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Trial record 25 of 1449 for:    prostate cancer AND radiation

Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Rising Prostate-Specific Antigen Levels After Radical Prostatectomy for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00551525
Recruitment Status : Completed
First Posted : October 31, 2007
Results First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Radiation: Radiotherapy
Drug: Samarium 153
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiotherapy + Samarium 153
Hide Arm/Group Description Samarium 153 infusion followed by radiotherapy 12 weeks later
Period Title: Overall Study
Started 67
Completed 62 [1]
Not Completed 5
Reason Not Completed
Protocol Violation             5
[1]
Subjects with data available for analysis are considered to have completed the study
Arm/Group Title Radiotherapy + Samarium 153
Hide Arm/Group Description Samarium 153 infusion followed by radiotherapy 12 weeks later
Overall Number of Baseline Participants 62
Hide Baseline Analysis Population Description
All eligible patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 62 participants
65
(49 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
Female
0
   0.0%
Male
62
 100.0%
1.Primary Outcome
Title Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration
Hide Description A PSA response for each patient is calculated by (baseline PSA-current PSA)/baseline PSA. A decline of at least 30% is considered a response. Null hypothesis (H0): Samarium 153 is not effective (pt ≤ 0.1) vs alternative hypothesis (HA): Samarium 153 is effective (pt ≥ 0.25). The sample size of 69 analyzable patients (eligible patients receiving any protocol treatment with ≥ 12 weeks follow-up from the Samarium 153 injection) was calculated based on Fleming’s Multiple Testing Procedure at a significance level of 0.019 and 91% statistical power requiring 69 patients to conclude either the null or alternative hypotheses. With only 52 analyzable patients this study had only 78% power and needed at least 11 patients with a PSA response to reject H0.
Time Frame Twelve weeks from the date of Samarium 153 infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who received Samarium 153 with at least 12 weeks follow-up from the injection
Arm/Group Title Radiotherapy + Samarium 153
Hide Arm/Group Description:
Samarium 153 infusion followed by radiotherapy 12 weeks later
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: percentage of participants
7
2.Secondary Outcome
Title Completion of Therapy
Hide Description The completion of protocol treatment is defined as receiving at least 64.8 Gy radiation after the Samarium 153 injection. The null hypothesis that the proportion of the number of patients who complete the protocol treatment (the Samarium 153 and the radiation therapy) is less than or equal to 0.5 was tested using an exact test for a binomial proportion. If the true treatment completion proportion is 0.8, then the statistical power of a one-sided 0.378 level exact binomial test of proportion would be 94.1% with the sample size of 26. Therefore any number of analyzable patients greater than 26 patients provides enough power for this endpoint.
Time Frame 90 days from the end of radiation therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment and did not withdraw consent prior to 90 days from the end of radiation therapy
Arm/Group Title Radiotherapy + Samarium 153
Hide Arm/Group Description:
Samarium 153 infusion followed by radiotherapy 12 weeks later
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.3
(87.0 to 99.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiotherapy + Samarium 153
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Significance level 0.05, two-sided test
Method binomial proportion
Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients With Hematologic Toxicity at 12 Weeks
Hide Description Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Hematological toxicities consist of platelet grade 3-5, white blood cell grade 3-5, hemoglobin grade 3-5, and any secondary leukemia's.
Time Frame Twelve weeks from the date of Samarium 153 infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Radiotherapy + Samarium 153
Hide Arm/Group Description:
Samarium 153 infusion followed by radiotherapy 12 weeks later
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
15
  25.0%
4.Secondary Outcome
Title Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients)
Hide Description

Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. The treatment-related attribution includes definitely, probably or possibly related to treatment. The treatment-related adverse events are:

  • HEMATOLOGIC Platelet grade 3-5 White blood cell count (WBC) grade 3-5 Hemoglobin grade 3-5 Any secondary leukemia’s
  • HEMORRHAGE/BLEEDING Hemorrhage, gastrointestinal - anus, rectum grade 3-5 Hemorrhage, genitourinary - bladder, prostate, urethra grade 3-5
  • SAMARIUM 153-RELATED GRADE 5 ADVERSE EVENT PRIOR TO TREATMENT OF RADIATION.
Time Frame Twelve weeks from the date of Samarium 153 infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with adverse event data
Arm/Group Title Radiotherapy + Samarium 153
Hide Arm/Group Description:
Samarium 153 infusion followed by radiotherapy 12 weeks later
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
16
5.Secondary Outcome
Title Acute and Late Radiotherapy-Related Adverse Events
Time Frame 90 days from start of radiotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with adverse event data
Arm/Group Title Radiotherapy + Samarium 153
Hide Arm/Group Description:
Samarium 153 infusion followed by radiotherapy 12 weeks later
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Acute 35
Late 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radiotherapy + Samarium 153
Comments Modeling the association of age with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 [reference level]), baseline PSA, and Gleason score (<8 vs. 8-10[reference level]).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.984
Confidence Interval (2-Sided) 95%
0.910 to 1.063
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Radiotherapy + Samarium 153
Comments Modeling the association of baseline PSA with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 [reference level]), Gleason score (<8 vs. 8-10[reference level]), and age.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.020
Confidence Interval (2-Sided) 95%
0.890 to 1.169
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Radiotherapy + Samarium 153
Comments Modeling the association of clinical T-stage (pT2 vs. pT3 [reference level]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for baseline PSA, Gleason score (<8 vs. 8-10[reference level]), and age.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.307
Confidence Interval (2-Sided) 95%
0.364 to 4.697
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Radiotherapy + Samarium 153
Comments Modeling the association of Gleason score (<8 vs. 8-10[reference level]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 [reference level]), baseline PSA, and age.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.659
Confidence Interval (2-Sided) 95%
0.217 to 2.006
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Freedom From Progression (FFP) Rate at 2 Years
Hide Description Progression is defined as biochemical (PSA) failure at any time for 2 years after prostatic fossa radiation therapy (RT), initiation of systemic therapy, or clinical failure. Biochemical failure is defined as a rise of 0.2 ng/ml or more above the nadir PSA after completion of RT followed by another higher value, or a continued rise in the serum PSA despite RT. FFP rate at 2 years was to be compared to that predicted by the Kattan Nomograms. See "Limitations and Caveats" section.
Time Frame From randomization to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Radiotherapy + Samarium 153
Hide Arm/Group Description:
Samarium 153 infusion followed by radiotherapy 12 weeks later
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.50
(14.40 to 36.70)
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. Eligible patients with any adverse event data are included.
 
Arm/Group Title Radiotherapy + Samarium 153
Hide Arm/Group Description Samarium 153 infusion followed by radiotherapy 12 weeks later
All-Cause Mortality
Radiotherapy + Samarium 153
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Radiotherapy + Samarium 153
Affected / at Risk (%)
Total   5/60 (8.33%) 
General disorders   
Sudden death * 1  1/60 (1.67%) 
Investigations   
Leukopenia * 1  2/60 (3.33%) 
Neutrophil count decreased * 1  2/60 (3.33%) 
Platelet count decreased * 1  1/60 (1.67%) 
Vascular disorders   
Thrombosis * 1  1/60 (1.67%) 
*
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%
Radiotherapy + Samarium 153
Affected / at Risk (%)
Total   55/60 (91.67%) 
Blood and lymphatic system disorders   
Blood disorder * 1  7/60 (11.67%) 
Hemoglobin decreased * 1  25/60 (41.67%) 
Gastrointestinal disorders   
Constipation * 1  8/60 (13.33%) 
Diarrhea * 1  15/60 (25.00%) 
Gastrointestinal disorder * 1  9/60 (15.00%) 
Hemorrhoids * 1  4/60 (6.67%) 
Nausea * 1  6/60 (10.00%) 
Proctitis * 1  8/60 (13.33%) 
General disorders   
Fatigue * 1  30/60 (50.00%) 
Pain [other] * 1  3/60 (5.00%) 
Investigations   
Alanine aminotransferase increased * 1  3/60 (5.00%) 
Leukopenia * 1  39/60 (65.00%) 
Lymphopenia * 1  11/60 (18.33%) 
Neutrophil count decreased * 1  26/60 (43.33%) 
Platelet count decreased * 1  46/60 (76.67%) 
Metabolism and nutrition disorders   
Hyperglycemia * 1  6/60 (10.00%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity * 1  3/60 (5.00%) 
Nervous system disorders   
Dizziness * 1  3/60 (5.00%) 
Headache * 1  3/60 (5.00%) 
Renal and urinary disorders   
Urinary frequency * 1  26/60 (43.33%) 
Urinary incontinence * 1  16/60 (26.67%) 
Urinary retention * 1  4/60 (6.67%) 
Urogenital disorder * 1  10/60 (16.67%) 
Reproductive system and breast disorders   
Erectile dysfunction * 1  7/60 (11.67%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  3/60 (5.00%) 
Vascular disorders   
Hot flashes * 1  10/60 (16.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Comparison of freedom from progression rate at two years with Kattan Nomograms was not possible because the pretreatment data needed for the Kattan Nomograms was not collected.
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: NCT00551525     History of Changes
Obsolete Identifiers: NCT01317043
Other Study ID Numbers: RTOG-0622
CDR0000570622
NCI-2009-01094 ( Registry Identifier: CTRP(Clinical Trial Reporting Program) )
First Submitted: October 30, 2007
First Posted: October 31, 2007
Results First Submitted: September 6, 2016
Results First Posted: July 25, 2017
Last Update Posted: July 25, 2017