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Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00288080
Recruitment Status : Active, not recruiting
First Posted : February 7, 2006
Results First Posted : January 23, 2017
Last Update Posted : February 26, 2019
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 Drug: Dexamethasone
Drug: Prednisone
Drug: docetaxel
Drug: Oral antiandrogen
Radiation: Radiation therapy
Drug: LHRH agonist
Enrollment 612
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Androgen Suppression + Radiation Therapy (RT) Androgen Suppression + Radiation Therapy + Chemotherapy
Hide Arm/Group Description Androgen suppression (AS; luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Period Title: Overall Study
Started 307 305
Completed 281 [1] 282 [1]
Not Completed 26 23
Reason Not Completed
Withdrawal by Subject             1             3
Protocol Violation             25             20
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title Androgen Suppression + Radiation Therapy Androgen Suppression + Radiation Therapy + Chemotherapy Total
Hide Arm/Group Description Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression. Total of all reporting groups
Overall Number of Baseline Participants 281 282 563
Hide Baseline Analysis Population Description
Eligible patients who have not withdrawn consent.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 281 participants 282 participants 563 participants
66
(47 to 83)
66
(46 to 83)
66
(46 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 281 participants 282 participants 563 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
281
 100.0%
282
 100.0%
563
 100.0%
1.Primary Outcome
Title Overall Survival
Hide Description Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Time Frame From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Androgen Suppression + Radiation Therapy Androgen Suppression + Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Overall Number of Participants Analyzed 281 282
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.7
(84.3 to 91.9)
93.3
(89.6 to 95.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androgen Suppression + Radiation Therapy, Androgen Suppression + Radiation Therapy + Chemotherapy
Comments The study was designed to detect an improvement in the 4-year overall survival rate from 86% (AS+RT) to 93% (AS+RT+CT). Assuming an exponential survival distribution for each arm, then an absolute improvement of 7% in the 4-year overall survival rate translates to a 51% relative reduction (hazard ratio 0.49) in the yearly death rate. Under a 1-sided significance level of 0.05 and 90% power, at least 78 deaths and 486 cases were required to perform the primary endpoint analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0398
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Biochemical Control
Hide Description Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization.
Time Frame From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Androgen Suppression + Radiation Therapy Androgen Suppression + Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Overall Number of Participants Analyzed 281 282
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82.0
(76.7 to 86.1)
84.1
(79 to 88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androgen Suppression + Radiation Therapy, Androgen Suppression + Radiation Therapy + Chemotherapy
Comments Biochemical control rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-sided log-rank test with a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Local Control
Hide Description Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method.
Time Frame From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent
Arm/Group Title Androgen Suppression + Radiation Therapy Androgen Suppression + Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Overall Number of Participants Analyzed 281 282
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.2
(97.0 to 99.8)
99.5
(96.6 to 99.9)
4.Secondary Outcome
Title Distant Metastasis
Hide Description Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method.
Time Frame From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Androgen Suppression + Radiation Therapy Androgen Suppression + Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Overall Number of Participants Analyzed 281 282
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.6
(1.1 to 5)
1.9
(0.7 to 4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androgen Suppression + Radiation Therapy, Androgen Suppression + Radiation Therapy + Chemotherapy
Comments Distant failure rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-side log-rank test at the 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title Disease-free Survival
Hide Description A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method.
Time Frame From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent.
Arm/Group Title Androgen Suppression + Radiation Therapy Androgen Suppression + Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Overall Number of Participants Analyzed 281 282
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.0
(67.4 to 77.9)
78.5
(73.1 to 82.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Androgen Suppression + Radiation Therapy, Androgen Suppression + Radiation Therapy + Chemotherapy
Comments Disease-free survival rates were compared by a two-sided log-rank test at a significance level of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0484
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Incidence of Adverse Events
Hide Description Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted.
Time Frame From start of treatment until the end of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started protocol treatment and did not withdraw consent
Arm/Group Title Androgen Suppression + Radiation Therapy Androgen Suppression + Radiation Therapy + Chemotherapy
Hide Arm/Group Description:
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
Overall Number of Participants Analyzed 281 282
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 14.9 2.1
Grade 2 48.4 25.9
Grade 3 26.0 40.1
Grade 4 4.3 28.4
Grade 5 1.4 0.7
7.Secondary Outcome
Title The Time Interval Between Biochemical Failure and Distant Metastases With Respect to Testosterone Level
Hide Description [Not Specified]
Time Frame From date of biochemical failure to development of distant failure. Analysis occurs after all patients have been potentially followed for 4 years.
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Validity of PSA-defined Endpoints as a Surrogate for Overall Survival
Hide Description [Not Specified]
Time Frame From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description All patients who received protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title Androgen Suppression + Radiation Therapy Androgen Suppression + Radiation Therapy + Chemotherapy
Hide Arm/Group Description Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
All-Cause Mortality
Androgen Suppression + Radiation Therapy Androgen Suppression + Radiation Therapy + Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Androgen Suppression + Radiation Therapy Androgen Suppression + Radiation Therapy + Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   25/302 (8.28%)   91/302 (30.13%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  0/302 (0.00%)  12/302 (3.97%) 
Hemoglobin * 1  0/302 (0.00%)  10/302 (3.31%) 
Cardiac disorders     
Angina pectoris * 1  0/302 (0.00%)  1/302 (0.33%) 
Atrial fibrillation * 1  0/302 (0.00%)  3/302 (0.99%) 
Cardiac general - Other * 1  1/302 (0.33%)  3/302 (0.99%) 
Myocardial ischemia * 1  5/302 (1.66%)  5/302 (1.66%) 
Myocarditis NOS * 1  0/302 (0.00%)  1/302 (0.33%) 
Ventricular arrhythmia NOS * 1  0/302 (0.00%)  2/302 (0.66%) 
Gastrointestinal disorders     
Abdominal pain NOS * 1  0/302 (0.00%)  2/302 (0.66%) 
Colitis NOS * 1  0/302 (0.00%)  2/302 (0.66%) 
Colonic hemorrhage * 1  0/302 (0.00%)  1/302 (0.33%) 
Colonic perforation * 1  0/302 (0.00%)  1/302 (0.33%) 
Diarrhea NOS * 1  1/302 (0.33%)  9/302 (2.98%) 
Gastritis NOS * 1  0/302 (0.00%)  1/302 (0.33%) 
Gastrointestinal - Other * 1  0/302 (0.00%)  1/302 (0.33%) 
Ileus paralytic * 1  1/302 (0.33%)  0/302 (0.00%) 
Lower gastrointestinal hemorrhage * 1  0/302 (0.00%)  1/302 (0.33%) 
Nausea * 1  1/302 (0.33%)  3/302 (0.99%) 
Pancreatitis NOS * 1  0/302 (0.00%)  1/302 (0.33%) 
Proctalgia * 1  0/302 (0.00%)  1/302 (0.33%) 
Stomatitis * 1  0/302 (0.00%)  1/302 (0.33%) 
Vomiting NOS * 1  1/302 (0.33%)  1/302 (0.33%) 
General disorders     
Chest pain * 1  1/302 (0.33%)  0/302 (0.00%) 
Edema: limb * 1  1/302 (0.33%)  0/302 (0.00%) 
Fatigue * 1  0/302 (0.00%)  4/302 (1.32%) 
Multi-organ failure * 1  0/302 (0.00%)  1/302 (0.33%) 
Pyrexia * 1  0/302 (0.00%)  1/302 (0.33%) 
Sudden death * 1  3/302 (0.99%)  0/302 (0.00%) 
Syndromes - Other * 1  0/302 (0.00%)  1/302 (0.33%) 
Immune system disorders     
Hypersensitivity NOS * 1  0/302 (0.00%)  1/302 (0.33%) 
Infections and infestations     
Bladder infection NOS * 1  0/302 (0.00%)  1/302 (0.33%) 
Infection - Other * 1  1/302 (0.33%)  0/302 (0.00%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Brain + Spinal cord (encephalomyelitis) * 1  0/302 (0.00%)  1/302 (0.33%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Blood * 1  0/302 (0.00%)  1/302 (0.33%) 
Infection with unknown ANC: Skin (cellulitis) * 1  0/302 (0.00%)  1/302 (0.33%) 
Kidney infection NOS * 1  1/302 (0.33%)  0/302 (0.00%) 
Lymph gland infection * 1  0/302 (0.00%)  1/302 (0.33%) 
Pneumonia NOS * 1  1/302 (0.33%)  0/302 (0.00%) 
Urinary tract infection NOS * 1  1/302 (0.33%)  1/302 (0.33%) 
Injury, poisoning and procedural complications     
Dermatitis radiation NOS * 1  1/302 (0.33%)  0/302 (0.00%) 
Fracture NOS * 1  1/302 (0.33%)  1/302 (0.33%) 
Vascular access NOS complication * 1  0/302 (0.00%)  1/302 (0.33%) 
Investigations     
Blood creatine phosphokinase increased * 1  0/302 (0.00%)  1/302 (0.33%) 
Blood creatinine increased * 1  0/302 (0.00%)  2/302 (0.66%) 
Hypercholesterolemia * 1  1/302 (0.33%)  1/302 (0.33%) 
Leukopenia NOS * 1  0/302 (0.00%)  24/302 (7.95%) 
Lymphopenia * 1  0/302 (0.00%)  4/302 (1.32%) 
Metabolic/laboratory - Other * 1  1/302 (0.33%)  1/302 (0.33%) 
Neutrophil count * 1  0/302 (0.00%)  34/302 (11.26%) 
Platelet count decreased * 1  1/302 (0.33%)  1/302 (0.33%) 
Troponin I increased * 1  0/302 (0.00%)  2/302 (0.66%) 
Weight decreased * 1  0/302 (0.00%)  2/302 (0.66%) 
Metabolism and nutrition disorders     
Anorexia * 1  0/302 (0.00%)  2/302 (0.66%) 
Dehydration * 1  1/302 (0.33%)  4/302 (1.32%) 
Glucose tolerance impaired * 1  0/302 (0.00%)  2/302 (0.66%) 
Hyperglycemia NOS * 1  0/302 (0.00%)  4/302 (1.32%) 
Hyperkalemia * 1  0/302 (0.00%)  2/302 (0.66%) 
Hypertriglyceridemia * 1  0/302 (0.00%)  1/302 (0.33%) 
Hypokalemia * 1  0/302 (0.00%)  1/302 (0.33%) 
Hyponatremia * 1  0/302 (0.00%)  1/302 (0.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/302 (0.00%)  1/302 (0.33%) 
Bone pain * 1  0/302 (0.00%)  2/302 (0.66%) 
Chest wall pain * 1  0/302 (0.00%)  1/302 (0.33%) 
Muscle weakness NOS * 1  1/302 (0.33%)  0/302 (0.00%) 
Musculoskeletal/soft tissue - Other * 1  1/302 (0.33%)  0/302 (0.00%) 
Myalgia * 1  0/302 (0.00%)  1/302 (0.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Secondary Malignancy - possibly related to cancer treatment * 1  1/302 (0.33%)  0/302 (0.00%) 
Nervous system disorders     
Cerebral ischemia * 1  1/302 (0.33%)  1/302 (0.33%) 
Dizziness * 1  1/302 (0.33%)  1/302 (0.33%) 
Neurology - Other * 1  1/302 (0.33%)  0/302 (0.00%) 
Peripheral motor neuropathy * 1  1/302 (0.33%)  1/302 (0.33%) 
Peripheral sensory neuropathy * 1  0/302 (0.00%)  2/302 (0.66%) 
Syncope * 1  0/302 (0.00%)  2/302 (0.66%) 
Psychiatric disorders     
Depression * 1  0/302 (0.00%)  1/302 (0.33%) 
Euphoric mood * 1  0/302 (0.00%)  1/302 (0.33%) 
Insomnia * 1  0/302 (0.00%)  1/302 (0.33%) 
Libido decreased * 1  0/302 (0.00%)  1/302 (0.33%) 
Renal and urinary disorders     
Cystitis NOS * 1  1/302 (0.33%)  2/302 (0.66%) 
Pollakiuria * 1  1/302 (0.33%)  2/302 (0.66%) 
Renal failure NOS * 1  1/302 (0.33%)  3/302 (0.99%) 
Urinary incontinence * 1  0/302 (0.00%)  2/302 (0.66%) 
Urinary retention * 1  0/302 (0.00%)  1/302 (0.33%) 
Reproductive system and breast disorders     
Erectile dysfunction NOS * 1  0/302 (0.00%)  4/302 (1.32%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  0/302 (0.00%)  1/302 (0.33%) 
Cough * 1  0/302 (0.00%)  1/302 (0.33%) 
Dyspnea * 1  3/302 (0.99%)  4/302 (1.32%) 
Hypoxia * 1  1/302 (0.33%)  0/302 (0.00%) 
Pneumonitis NOS * 1  1/302 (0.33%)  2/302 (0.66%) 
Pulmonary/upper respiratory - Other * 1  0/302 (0.00%)  1/302 (0.33%) 
Skin and subcutaneous tissue disorders     
Dermatology/skin - Other * 1  1/302 (0.33%)  0/302 (0.00%) 
Localised exfoliation * 1  0/302 (0.00%)  1/302 (0.33%) 
Sweating increased * 1  1/302 (0.33%)  0/302 (0.00%) 
Vascular disorders     
Hot flushes NOS * 1  2/302 (0.66%)  1/302 (0.33%) 
Hypertension NOS * 1  0/302 (0.00%)  1/302 (0.33%) 
Hypotension NOS * 1  1/302 (0.33%)  2/302 (0.66%) 
Peripheral ischemia * 1  1/302 (0.33%)  0/302 (0.00%) 
Thrombosis * 1  0/302 (0.00%)  2/302 (0.66%) 
*
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%
Androgen Suppression + Radiation Therapy Androgen Suppression + Radiation Therapy + Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   278/302 (92.05%)   289/302 (95.70%) 
Blood and lymphatic system disorders     
Blood/bone marrow - Other * 1  3/302 (0.99%)  18/302 (5.96%) 
Hemoglobin * 1  37/302 (12.25%)  176/302 (58.28%) 
Eye disorders     
Lacrimation increased * 1  2/302 (0.66%)  16/302 (5.30%) 
Gastrointestinal disorders     
Abdominal pain NOS * 1  15/302 (4.97%)  23/302 (7.62%) 
Constipation * 1  28/302 (9.27%)  53/302 (17.55%) 
Diarrhea NOS * 1  153/302 (50.66%)  159/302 (52.65%) 
Dyspepsia * 1  5/302 (1.66%)  25/302 (8.28%) 
Fecal incontinence * 1  15/302 (4.97%)  13/302 (4.30%) 
Gastrointestinal - Other * 1  19/302 (6.29%)  24/302 (7.95%) 
Nausea * 1  13/302 (4.30%)  81/302 (26.82%) 
Proctitis NOS * 1  43/302 (14.24%)  47/302 (15.56%) 
Rectal hemorrhage * 1  37/302 (12.25%)  41/302 (13.58%) 
Stomatitis * 1  0/302 (0.00%)  29/302 (9.60%) 
Vomiting NOS * 1  8/302 (2.65%)  18/302 (5.96%) 
General disorders     
Edema: limb * 1  15/302 (4.97%)  51/302 (16.89%) 
Fatigue * 1  157/302 (51.99%)  235/302 (77.81%) 
Pain - Other * 1  14/302 (4.64%)  25/302 (8.28%) 
Investigations     
Alanine aminotransferase increased * 1  16/302 (5.30%)  31/302 (10.26%) 
Aspartate aminotransferase increased * 1  17/302 (5.63%)  23/302 (7.62%) 
Blood alkaline phosphatase increased * 1  7/302 (2.32%)  15/302 (4.97%) 
Leukopenia NOS * 1  20/302 (6.62%)  145/302 (48.01%) 
Lymphopenia * 1  23/302 (7.62%)  63/302 (20.86%) 
Metabolic/laboratory - Other * 1  4/302 (1.32%)  25/302 (8.28%) 
Neutrophil count * 1  3/302 (0.99%)  107/302 (35.43%) 
Platelet count decreased * 1  11/302 (3.64%)  34/302 (11.26%) 
Weight decreased * 1  5/302 (1.66%)  17/302 (5.63%) 
Weight increased * 1  21/302 (6.95%)  40/302 (13.25%) 
Metabolism and nutrition disorders     
Anorexia * 1  7/302 (2.32%)  33/302 (10.93%) 
Hyperglycemia NOS * 1  16/302 (5.30%)  102/302 (33.77%) 
Hypoalbuminemia * 1  5/302 (1.66%)  32/302 (10.60%) 
Hypokalemia * 1  2/302 (0.66%)  16/302 (5.30%) 
Hyponatremia * 1  3/302 (0.99%)  28/302 (9.27%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  25/302 (8.28%)  63/302 (20.86%) 
Back pain * 1  24/302 (7.95%)  44/302 (14.57%) 
Bone pain * 1  9/302 (2.98%)  18/302 (5.96%) 
Muscle weakness NOS * 1  16/302 (5.30%)  23/302 (7.62%) 
Musculoskeletal/soft tissue - Other * 1  7/302 (2.32%)  17/302 (5.63%) 
Myalgia * 1  10/302 (3.31%)  36/302 (11.92%) 
Pain in extremity * 1  10/302 (3.31%)  29/302 (9.60%) 
Nervous system disorders     
Dizziness * 1  8/302 (2.65%)  29/302 (9.60%) 
Dysgeusia * 1  2/302 (0.66%)  53/302 (17.55%) 
Peripheral motor neuropathy * 1  6/302 (1.99%)  19/302 (6.29%) 
Peripheral sensory neuropathy * 1  20/302 (6.62%)  110/302 (36.42%) 
Psychiatric disorders     
Anxiety * 1  7/302 (2.32%)  15/302 (4.97%) 
Depression * 1  20/302 (6.62%)  20/302 (6.62%) 
Insomnia * 1  22/302 (7.28%)  53/302 (17.55%) 
Libido decreased * 1  65/302 (21.52%)  63/302 (20.86%) 
Renal and urinary disorders     
Bladder pain * 1  6/302 (1.99%)  18/302 (5.96%) 
Cystitis NOS * 1  33/302 (10.93%)  41/302 (13.58%) 
Pollakiuria * 1  207/302 (68.54%)  211/302 (69.87%) 
Renal/genitourinary - Other * 1  37/302 (12.25%)  46/302 (15.23%) 
Urinary incontinence * 1  33/302 (10.93%)  46/302 (15.23%) 
Urinary retention * 1  55/302 (18.21%)  56/302 (18.54%) 
Urogenital hemorrhage * 1  10/302 (3.31%)  15/302 (4.97%) 
Reproductive system and breast disorders     
Ejaculatory disorder NOS * 1  22/302 (7.28%)  23/302 (7.62%) 
Erectile dysfunction NOS * 1  121/302 (40.07%)  120/302 (39.74%) 
Gynecomastia * 1  20/302 (6.62%)  25/302 (8.28%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  10/302 (3.31%)  40/302 (13.25%) 
Dyspnea * 1  27/302 (8.94%)  68/302 (22.52%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  7/302 (2.32%)  119/302 (39.40%) 
Dermatitis exfoliative NOS * 1  7/302 (2.32%)  28/302 (9.27%) 
Dermatology/skin - Other * 1  12/302 (3.97%)  24/302 (7.95%) 
Dry skin * 1  3/302 (0.99%)  18/302 (5.96%) 
Nail disorder NOS * 1  1/302 (0.33%)  51/302 (16.89%) 
Sweating increased * 1  14/302 (4.64%)  22/302 (7.28%) 
Vascular disorders     
Hot flushes NOS * 1  206/302 (68.21%)  192/302 (63.58%) 
Hypertension NOS * 1  8/302 (2.65%)  15/302 (4.97%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Due to insufficient number of events, local control analysis was not conducted.
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
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00288080     History of Changes
Other Study ID Numbers: RTOG-0521
CDR0000462375
NCI-2009-00728 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: February 6, 2006
First Posted: February 7, 2006
Results First Submitted: November 28, 2016
Results First Posted: January 23, 2017
Last Update Posted: February 26, 2019