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Radiation Therapy in Treating Patients With Stage II Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00331773
Recruitment Status : Active, not recruiting
First Posted : May 31, 2006
Results First Posted : April 13, 2017
Last Update Posted : April 12, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Radiation: Conventional 3D-CRT or IMRT
Radiation: Hypofractionated 3D-CRT or IMRT
Enrollment 1115
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description Conventional 3D-CRT or intensity-modulated radiotherapy (IMRT): Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Period Title: Overall Study
Started 558 557
Completed 542 [1] 550 [1]
Not Completed 16 7
Reason Not Completed
Withdrawal by Subject             6             4
Protocol Violation             10             3
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT Total
Hide Arm/Group Description Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy. Total of all reporting groups
Overall Number of Baseline Participants 542 550 1092
Hide Baseline Analysis Population Description
Eligible patients who did not withdraw consent.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 542 participants 550 participants 1092 participants
67
(42 to 85)
67
(45 to 84)
67
(42 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 542 participants 550 participants 1092 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
542
 100.0%
550
 100.0%
1092
 100.0%
1.Primary Outcome
Title Five-year Disease-free Survival (DFS) Rate
Hide Description Five-year rates are estimated by the Kaplan-Meier method. DFS events included local progression, distant metastatic progression, biochemical recurrence as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, or death from any cause. Patients who experienced second primary cancers remained under observation for DFS events.
Time Frame Analysis occurs after all patients have been followed for five years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description:
Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Number of Participants Analyzed 542 550
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85.3
(81.9 to 88.1)
86.3
(83.1 to 89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments This trial was designed to establish with 90% power and a two-sided significance level of 0.05 that Arm 2 (Hypofractionated 3D-CRT) results in a 5-year DFS that is not lower than Arm 1 by more than 7.65% (hazard ratio [HR] , 1.52). Patients analyzed according to assignment, with time-to event duration originating at random assignment. DFS distributions calculated using the Kaplan-Meier method. Treatment efficacy for DFS was tested by comparing cause-specific hazards with the log-rank statistic.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.64 to 1.14
Estimation Comments Reference arm = Conventional 3D-CRT
2.Secondary Outcome
Title Five-year Local Progression Rate
Hide Description Clinical criteria for local recurrence are progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by 2 years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local recurrence are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than 2 years after the start of treatment. The arms were not statistically compared because of an insufficient number of events.
Time Frame Analysis occurs after all patients have been followed for five years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible patients.
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description:
Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Number of Participants Analyzed 542 550
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.2
(0.5 to 2.4)
0.4
(0.1 to 1.3)
3.Secondary Outcome
Title Five-year Disease-specific Survival Rate
Hide Description

An event was death in association with any of the following conditions:

  • Primary cause of death certified as due to prostate cancer
  • Further clinical tumor progression occurring after initiation of "salvage" anti-tumor (e.g., (androgen suppression) therapy
  • A rise (that exceeds 1.0 ng/mL) in the serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after "salvage" androgen suppression therapy
  • Disease progression in the absence of any anti-tumor therapy
  • Death from a complication of therapy, irrespective of disease status. The arms were not statistically compared because of an insufficient number of events.
Time Frame Analysis occurs after all patients have been followed for five years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible patients
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description:
Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Number of Participants Analyzed 542 550
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.2
(0.0 to 1.0)
0.2
(0.1 to 1.1)
4.Secondary Outcome
Title Five-year PSA Failure Rate
Hide Description Five-year rates are shown (cumulative incidence estimates). Note, although the protocol calls this endpoint "Freedom from biochemical recurrence", it defines the endpoint as "The time to PSA failure". An event for PSA, i.e. biochemical, failure was the first of the following: initiation of non-protocol (e.g., salvage) hormone therapy, or an increase in PSA of at least 2 ng/dl. Time to biochemical failure was measured from study entry until the date of failure.
Time Frame Analysis occurs after all patients have been followed for five years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description:
Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Number of Participants Analyzed 542 550
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.1
(5.9 to 10.6)
6.3
(4.5 to 8.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Patients who died without biochemical failure were considered as competing risk at the time of death. Patients alive without biochemical failure at last follow-up were censored at that date. Estimates were calculated using cumulative risk and non-inferiority was assessed against a HR of 1.67. The log-rank test was used with a two-sided p-value of 0.05.
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.51 to 1.17
Estimation Comments Reference arm = Conventional 3D-CRT
5.Secondary Outcome
Title Five-year Overall Survival Rate
Hide Description Five-year rates Kaplan-Meier estimates. Overall survival (OS) was measured from study entry until the date of death. Patients still alive at the time of analysis were censored at the date of last follow-up
Time Frame Analysis occurs after all patients have been followed for five years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description:
Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Number of Participants Analyzed 542 550
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.2
(90.7 to 95.1)
92.5
(89.9 to 94.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was assessed against a HR of 1.54, translated from a 5% difference in overall survival with 90% overall survival in the Conventional 3D-CRT arm. The log-rank test was used with a two-sided p-value of 0.05.
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.64 to 1.41
Estimation Comments Reference arm = Conventional 3D-CRT
6.Secondary Outcome
Title Frequency of Patients With GU and GI Acute and Late Toxicity
Hide Description The frequency of genitourinary (GU) and gastrointestinal (GI) adverse events as defined and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3) were compared between treatment arms. Acute toxicity was defined as any toxicity beginning within 90 days of completion of RT, and late toxicity was defined as any toxicity beginning more than 90 days after the completion of RT. Acute and late GU and GI toxicity rates were tabulated and reported in two ways: dichotomized as < grade 2 vs ≥ grade 2, and dichotomized as < grade 3 vs ≥ grade 3. Higher grade indicates more severity.
Time Frame Acute toxicity is measured from start of treatment to 90 days from the completion of treatment. Late toxicity is defined as toxicity occuring after 90 days from completion of treatment. Analysis occured at the time of the primary endpoint analysis.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment and did not withdraw consent
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description:
Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Number of Participants Analyzed 534 545
Measure Type: Number
Unit of Measure: participants
Acute GI: Grade >= 2: 55 58
Acute GI: Grade >= 3 3 4
Acute GU: Grade >= 2 145 147
Acute GU: Grade >= 3 13 18
Late GI: Grade >= 2 75 121
Late GI: Grade >= 3 14 22
Late GU: Grade >= 2 121 161
Late GU: Grade >= 3 12 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments Acute GI toxicity rates were tabulated and dichotomized as < grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% confidence intervals (CIs) were computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments 2-sided
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.73 to 1.46
Estimation Comments Reference arm = Conventional 3D-CRT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments Acute GI toxicity rates were tabulated and dichotomized as < grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments 2-sided
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.29 to 5.81
Estimation Comments Reference arm = Conventional 3D-CRT
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments Acute GU toxicity rates were tabulated and dichotomized as < grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments 2-sided
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.82 to 1.21
Estimation Comments Reference Arm = Conventional 3D-CRT
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments Acute GU toxicity rates were tabulated and dichotomized as < grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments 2-sided
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.67 to 2.74
Estimation Comments Reference arm = Conventional 3D-CRT
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments Late GI toxicity rates were tabulated and dichotomized as < grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments 2-sided
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
1.22 to 2.06
Estimation Comments Reference arm = Conventional 3D-CRT
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments Late GI toxicity rates were tabulated and dichotomized as < grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments 2-sided
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
0.80 to 2.99
Estimation Comments Reference arm = Conventional 3D-CRT
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments Late GU toxicity rates were tabulated and dichotomized as < grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments 2-sided
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
1.07 to 1.61
Estimation Comments Reference arm = Conventional 3D-CRT
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments Late GU toxicity rates were tabulated and dichotomized as < grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments 2-sided
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
0.76 to 3.18
Estimation Comments Reference arm = Conventional 3D-CRT
7.Secondary Outcome
Title Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC
Hide Description Prostate cancer (PC) Health-Related Quality of Life (HRQOL) outcomes as measured by change over time in the Expanded Prostate Cancer Index Composite [EPIC], a PC HRQOL instrument measuring a broad spectrum of urinary, bowel, and sexual symptoms related to radiotherapy, is compared between arms. The EPIC questionnaire was grouped into four domains (bowel, urinary, sexual, hormonal), each with a score ranging from 0 (worst) to 100 (best), and was assessed at baseline, 6, 12, and 24 months, and 5 years. The difference in score from baseline to each time point was calculated and the Wilcoxon test statistic was used to test the null hypothesis that responses are the same across the two treatment arms vs. the alternative hypothesis that they are different, using a 2-sided alpha of 0.05 at each timepoint, resulting in an alpha of 0.0125 for each domain. Each row refers to a separate analysis.
Time Frame Baseline, 6, 12, and 24 months, and 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with both a baseline and follow-up EPIC domain score, who did not withdraw consent
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description:
Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Number of Participants Analyzed 542 550
Mean (Standard Deviation)
Unit of Measure: units on a scale
6 mo. EPIC Bowel Domain Number Analyzed 371 participants 401 participants
-4  (12.1) -3.7  (11.7)
6 mo. EPIC Urinary Domain Number Analyzed 292 participants 338 participants
0  (10.5) -1.5  (11.9)
6 mo. EPIC Sexual Domain Number Analyzed 274 participants 310 participants
-8.1  (20.9) -7.8  (17.8)
6 mo. EPIC Hormonal Domain Number Analyzed 285 participants 326 participants
-2.4  (10.5) -1.8  (10)
12 mo. EPIC Bowel Domain (n=273, 294) Number Analyzed 273 participants 294 participants
-3.7  (11.4) -7.5  (14.6)
12 mo. EPIC Urinary Domain Number Analyzed 275 participants 299 participants
-0.3  (10.4) -1.8  (13.1)
12 mo. EPIC Sexual Domain Number Analyzed 261 participants 271 participants
-8.1  (19.7) -8.4  (20)
12 mo. EPIC Hormonal Domain Number Analyzed 263 participants 288 participants
-1.6  (8.5) -1.6  (9.4)
24 mo. EPIC Bowel Domain Number Analyzed 251 participants 266 participants
-4.4  (12.4) -6  (12.7)
24 mo. EPIC Urinary Domain Number Analyzed 255 participants 271 participants
-0.5  (10.6) -0.7  (12.4)
24 mo. EPIC Sexual Domain Number Analyzed 238 participants 245 participants
-9.7  (21.1) -10.4  (21)
24 mo. EPIC Hormonal Domain Number Analyzed 244 participants 253 participants
-2.4  (9.5) -1.7  (10.5)
60 mo. EPIC Bowel Domain Number Analyzed 217 participants 239 participants
-3.6  (11.8) -5.2  (12.6)
60 mo. EPIC Urinary Domain Number Analyzed 222 participants 238 participants
-1.2  (12.4) -3.1  (15)
60 mo. EPIC Sexual Domain Number Analyzed 199 participants 217 participants
-13.5  (22.1) -15.7  (24.4)
60 mo. EPIC Hormonal Domain Number Analyzed 209 participants 226 participants
-2.1  (10.3) -2.1  (10.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Bowel Domain at 6 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Urinary Domain at 6 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Sexual Domain at 6 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Hormonal Domain at 6 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Bowel Domain at 12 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0037
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Urinary Domain at 12 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Sexual Domain at 12 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Hormonal Domain at 12 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Bowel Domain at 24 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Urinary Domain at 24 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Sexual Domain at 24 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Hormonal Domain at 24 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Bowel Domain at 60 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Urinary Domain at 60 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Sexual Domain at 60 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments EPIC Hormonal Domain at 60 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title The Utilization of Sexual Medications/Devices Questionaire
Hide Description The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The percentage of "Yes" responses to the following questions are reported: "Do you have a penile prosthesis", "Have you used an medications or devices to aid or improve erections?".
Time Frame Baseline, 6, 12, and 24 months, and 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients answering the questionaire, who did not withdraw consent
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description:
Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Number of Participants Analyzed 478 484
Measure Type: Number
Unit of Measure: percentage of participants
Baseline penile prosthesis question Number Analyzed 399 participants 414 participants
2.0 0.0
Baseline medications/devices question Number Analyzed 375 participants 400 participants
24.5 23.0
6 mo. penile prosthesis question Number Analyzed 314 participants 361 participants
2.5 0.6
6 mo. medications/devices question Number Analyzed 292 participants 345 participants
25.0 24.1
12 mo. penile prosthesis question Number Analyzed 286 participants 309 participants
0.3 0.6
12 mo. medications/devices question Number Analyzed 270 participants 300 participants
29.6 30.3
24 mo. penile prosthesis question Number Analyzed 268 participants 283 participants
1.5 0
24 mo. medications/devices question Number Analyzed 259 participants 279 participants
36.3 33.3
60 mo. penile prosthesis question Number Analyzed 232 participants 255 participants
1.7 1.2
60 mo. medications/devices question Number Analyzed 227 participants 252 participants
35.2 31.7
9.Secondary Outcome
Title Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25
Hide Description Anxiety and depression were measured with the Hopkins Symptom Checklist (HSCL-25). It consists of 25 items: Part I of the HSCL-25 has 10 items for anxiety symptoms; Part II has 15 items for depression symptoms. The scale for each question includes four categories of response (“Not at all,” “A little,” “Quite a bit,” “Extremely,” rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items and ranges from 0 to 100. A higher score indicates worse symptoms. The HSCL-25 tool was assessed at baseline, 6 months, 12 months, 24 months, and 5 years. For each patient, the change in score from baseline to the time point is calculated by subtracting the baseline value from the time point value.
Time Frame Baseline, 6 months, 12 months, 24 months, and 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with a follow-up HSCL-25 who did not withdraw consent
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description:
Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Number of Participants Analyzed 298 336
Mean (Standard Deviation)
Unit of Measure: units on a scale
6 months Number Analyzed 298 participants 336 participants
31.2  (7.8) 31.8  (8.1)
12 months Number Analyzed 288 participants 308 participants
31.2  (7.3) 32.2  (9)
24 months Number Analyzed 230 participants 263 participants
31.1  (7.5) 31.7  (7.7)
5 years Number Analyzed 182 participants 189 participants
30.8  (7.1) 32.1  (7.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments The distribution of HSCL-25 at 6 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments The distribution of HSCL-25 at 12 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments The distribution of HSCL-25 at 24 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments The distribution of HSCL-25 at 60 months (5 years) was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title EQ-5D Scores
Hide Description The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 ―Worst health stat and 1 ―Best health state. A two-sided Wilcoxon test with alpha 0.05 was used due to the skewed, thus non-normal, nature of the data.
Time Frame Baseline, 6 months, 12 months, 24 months, and 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with a baseline or follow-up EQ-5D score who did not withdraw consent
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description:
Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Number of Participants Analyzed 418 439
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Baseline VAS Score Number Analyzed 402 participants 430 participants
85.0
(79.0 to 90.0)
82.0
(75.0 to 90.0)
Baseline Index Score Number Analyzed 416 participants 434 participants
1.0
(0.8 to 1.0)
1.0
(0.8 to 1.0)
6 mo. VAS Score Number Analyzed 316 participants 360 participants
85.0
(75.0 to 90.0)
85.0
(75.0 to 90.0)
6 mo. Index Score Number Analyzed 321 participants 364 participants
1.0
(0.8 to 1.0)
1.0
(0.8 to 1.0)
12 mo. VAS Score Number Analyzed 287 participants 0312 participants
85.0
(75.0 to 90.0)
81.5
(75.0 to 90.0)
12 mo. Index Score Number Analyzed 301 participants 319 participants
1.0
(0.8 to 1.0)
1.0
(0.8 to 1.0)
24 mo. VAS Score Number Analyzed 276 participants 280 participants
85.0
(75.0 to 90.0)
85.0
(75.0 to 90.0)
24 mo. Index Score Number Analyzed 275 participants 278 participants
1.0
(0.8 to 1.0)
1.0
(0.8 to 1.0)
60 mo. VAS Score Number Analyzed 231 participants 243 participants
85.0
(75.0 to 90.0)
82.0
(73.0 to 90.0)
60 mo. Index Score Number Analyzed 229 participants 248 participants
0.9
(0.8 to 1.0)
0.9
(0.8 to 1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments Baseline VAS score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Two-sided significance level = 0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments Baseline index score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments Two-sided significance level = 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments 6-month VAS score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments Two-sided significance level = 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments 6-month index score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments Two-sided significance level = 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments 12-month VAS score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments Two-sided significance level = 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments 12-month index score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments Two-sided significance level = 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments 24-month VAS score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments Two-sided significance level = 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments 24-month index score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments Two-sided significance level = 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments 60-month VAS score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments Two-sided significance level = 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Conventional 3D-CRT, Hypofractionated 3D-CRT
Comments 60-month index score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments Two-sided significance level = 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Assessment of Trade-off Between Disease-free Survival and Quality of Life.
Hide Description To examine trade-offs between the survival time and QOL, we were to combine them for each patient into two single measurements: quality adjusted live year (QALY) and quality adjusted disease-free survival year (QADFSY). We were to use Glasziou‘s multiple health-state (Q-TWiST) models to use the repeated measures of EQ-5D. This analysis was not conducted because there were no differences in EQ-5D scores. See results presented for Outcome Measure 10: Evaluation and Comparison of the Cost-utility of Each Treatment Arm Using EQ-5D.
Time Frame From baseline to 5 years from the start of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description:
Conventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy
Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Statistical Modeling of Genomic Biomarkers
Hide Description Biomarker data has not been obtained yet therefore this analysis has not occurred.
Time Frame Baseline biomarker collection will be used. Analysis occurs after the primary endpoint analysis.
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Collection of Paraffin-embedded Tissue Block, Serum, Plasma, and Buffy Coat Cells for Future Translational Research Analyses
Hide Description [Not Specified]
Time Frame From baseline to 5 years from the start of treatment.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title Conventional 3D-CRT Hypofractionated 3D-CRT
Hide Arm/Group Description CConventional 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy Hypofractionated 3D-CRT or IMRT: Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
All-Cause Mortality
Conventional 3D-CRT Hypofractionated 3D-CRT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Conventional 3D-CRT Hypofractionated 3D-CRT
Affected / at Risk (%) Affected / at Risk (%)
Total   26/534 (4.87%)   32/545 (5.87%) 
Blood and lymphatic system disorders     
Blood/bone marrow - Other * 1  0/534 (0.00%)  1/545 (0.18%) 
Hemoglobin * 1  1/534 (0.19%)  0/545 (0.00%) 
Cardiac disorders     
Arrhythmia NOS * 1  1/534 (0.19%)  0/545 (0.00%) 
Atrial fibrillation * 1  4/534 (0.75%)  0/545 (0.00%) 
Cardio-respiratory arrest * 1  1/534 (0.19%)  0/545 (0.00%) 
Palpitations * 1  1/534 (0.19%)  0/545 (0.00%) 
Sinus bradycardia * 1  1/534 (0.19%)  0/545 (0.00%) 
Gastrointestinal disorders     
Constipation * 1  2/534 (0.37%)  0/545 (0.00%) 
Diarrhea NOS * 1  2/534 (0.37%)  0/545 (0.00%) 
Duodenal obstruction * 1  1/534 (0.19%)  0/545 (0.00%) 
Fecal incontinence * 1  1/534 (0.19%)  0/545 (0.00%) 
Gastrointestinal - Other * 1  1/534 (0.19%)  0/545 (0.00%) 
Pancreatitis NOS * 1  0/534 (0.00%)  1/545 (0.18%) 
Proctalgia * 1  0/534 (0.00%)  1/545 (0.18%) 
Proctitis NOS * 1  3/534 (0.56%)  2/545 (0.37%) 
Rectal hemorrhage * 1  2/534 (0.37%)  2/545 (0.37%) 
Rectal perforation * 1  1/534 (0.19%)  0/545 (0.00%) 
General disorders     
Edema: limb * 1  1/534 (0.19%)  0/545 (0.00%) 
Fatigue * 1  1/534 (0.19%)  0/545 (0.00%) 
Hepatobiliary disorders     
Cholecystitis NOS * 1  0/534 (0.00%)  1/545 (0.18%) 
Infections and infestations     
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Gallbladder (cholecystitis) * 1  0/534 (0.00%)  1/545 (0.18%) 
Pneumonia NOS * 1  1/534 (0.19%)  0/545 (0.00%) 
Investigations     
Hypercholesterolemia * 1  0/534 (0.00%)  1/545 (0.18%) 
Metabolic/laboratory - Other * 1  1/534 (0.19%)  0/545 (0.00%) 
Metabolism and nutrition disorders     
Acidosis NOS * 1  0/534 (0.00%)  1/545 (0.18%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/534 (0.19%)  0/545 (0.00%) 
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower * 1  0/534 (0.00%)  1/545 (0.18%) 
Neck pain * 1  1/534 (0.19%)  0/545 (0.00%) 
Nervous system disorders     
Cerebral ischemia * 1  0/534 (0.00%)  2/545 (0.37%) 
Convulsions NOS * 1  1/534 (0.19%)  0/545 (0.00%) 
Dizziness * 1  0/534 (0.00%)  1/545 (0.18%) 
Psychiatric disorders     
Depression * 1  0/534 (0.00%)  1/545 (0.18%) 
Libido decreased * 1  1/534 (0.19%)  0/545 (0.00%) 
Renal and urinary disorders     
Bladder obstruction * 1  0/534 (0.00%)  1/545 (0.18%) 
Bladder pain * 1  0/534 (0.00%)  1/545 (0.18%) 
Pollakiuria * 1  4/534 (0.75%)  5/545 (0.92%) 
Renal/genitourinary - Other * 1  0/534 (0.00%)  2/545 (0.37%) 
Urinary bladder hemorrhage * 1  0/534 (0.00%)  1/545 (0.18%) 
Urinary incontinence * 1  0/534 (0.00%)  2/545 (0.37%) 
Urinary retention * 1  1/534 (0.19%)  2/545 (0.37%) 
Reproductive system and breast disorders     
Ejaculatory disorder NOS * 1  1/534 (0.19%)  0/545 (0.00%) 
Erectile dysfunction NOS * 1  4/534 (0.75%)  3/545 (0.55%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  1/534 (0.19%)  0/545 (0.00%) 
Atelectasis * 1  0/534 (0.00%)  1/545 (0.18%) 
Cough * 1  1/534 (0.19%)  0/545 (0.00%) 
Dyspnea * 1  3/534 (0.56%)  3/545 (0.55%) 
Vascular disorders     
Thrombosis * 1  1/534 (0.19%)  0/545 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Conventional 3D-CRT Hypofractionated 3D-CRT
Affected / at Risk (%) Affected / at Risk (%)
Total   457/534 (85.58%)   494/535 (92.34%) 
Gastrointestinal disorders     
Constipation * 1  53/534 (9.93%)  57/535 (10.65%) 
Diarrhea NOS * 1  170/534 (31.84%)  211/535 (39.44%) 
Fecal incontinence * 1  17/534 (3.18%)  33/535 (6.17%) 
Gastrointestinal - Other * 1  49/534 (9.18%)  71/535 (13.27%) 
Hemorrhoids * 1  36/534 (6.74%)  52/535 (9.72%) 
Proctitis NOS * 1  116/534 (21.72%)  160/535 (29.91%) 
Rectal hemorrhage * 1  88/534 (16.48%)  137/535 (25.61%) 
General disorders     
Fatigue * 1  159/534 (29.78%)  153/535 (28.60%) 
Pain - Other * 1  31/534 (5.81%)  40/535 (7.48%) 
Psychiatric disorders     
Libido decreased * 1  28/534 (5.24%)  35/535 (6.54%) 
Renal and urinary disorders     
Bladder pain * 1  31/534 (5.81%)  25/535 (4.67%) 
Cystitis NOS * 1  86/534 (16.10%)  105/535 (19.63%) 
Pollakiuria * 1  370/534 (69.29%)  400/535 (74.77%) 
Renal/genitourinary - Other * 1  81/534 (15.17%)  122/535 (22.80%) 
Urethral pain * 1  15/534 (2.81%)  32/535 (5.98%) 
Urinary incontinence * 1  62/534 (11.61%)  89/535 (16.64%) 
Urinary retention * 1  123/534 (23.03%)  139/535 (25.98%) 
Reproductive system and breast disorders     
Ejaculatory disorder NOS * 1  30/534 (5.62%)  33/535 (6.17%) 
Erectile dysfunction NOS * 1  196/534 (36.70%)  212/535 (39.63%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
Publications of Results:
McDonald AM, Dobelbower MC, Kim RY, et al.: Efficacy and rectal toxicity of hypofractionated radiation therapy with daily image guidance. [Abstract] J Clin Oncol 29 (Suppl 7): A-85, 2011.
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00331773     History of Changes
Other Study ID Numbers: RTOG-0415
CDR0000481119
NCI-2009-00721 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: May 30, 2006
First Posted: May 31, 2006
Results First Submitted: November 29, 2016
Results First Posted: April 13, 2017
Last Update Posted: April 12, 2018