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Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00567580
Recruitment Status : Active, not recruiting
First Posted : December 5, 2007
Results First Posted : March 2, 2021
Last Update Posted : May 13, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
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: PBRT
Radiation: PLNRT
Drug: AA
Drug: LHRH agonist
Enrollment 1792
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PBRT Alone PBRT + STAD PLNRT + PBRT + STAD
Hide Arm/Group Description Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Period Title: Overall Study
Started 592 602 598
Eligible 564 578 574
Eligible, Started Study Treatment, and Have Adverse Event Data 547 563 563
Completed [1] 564 578 574
Not Completed 28 24 24
Reason Not Completed
Protocol Violation             28             24             24
[1]
Participants contributing data to analysis are considered to have completed the study.
Arm/Group Title PBRT Alone PBRT + STAD PLNRT + PBRT + STAD Total
Hide Arm/Group Description Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). Total of all reporting groups
Overall Number of Baseline Participants 564 578 574 1716
Hide Baseline Analysis Population Description
Eligible participants
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 564 participants 578 participants 574 participants 1716 participants
64
(42 to 84)
64
(39 to 80)
64
(44 to 80)
64
(39 to 84)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age (years) Number Analyzed 564 participants 578 participants 574 participants 1716 participants
<=49
19
   3.4%
15
   2.6%
8
   1.4%
42
   2.4%
50-59
118
  20.9%
137
  23.7%
138
  24.0%
393
  22.9%
60-69
307
  54.4%
299
  51.7%
307
  53.5%
913
  53.2%
>=70
120
  21.3%
127
  22.0%
121
  21.1%
368
  21.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 564 participants 578 participants 574 participants 1716 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
564
 100.0%
578
 100.0%
574
 100.0%
1716
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 564 participants 578 participants 574 participants 1716 participants
Hispanic or Latino
21
   3.7%
23
   4.0%
30
   5.2%
74
   4.3%
Not Hispanic or Latino
511
  90.6%
527
  91.2%
517
  90.1%
1555
  90.6%
Unknown or Not Reported
32
   5.7%
28
   4.8%
27
   4.7%
87
   5.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 564 participants 578 participants 574 participants 1716 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
5
   0.9%
5
   0.3%
Asian
3
   0.5%
6
   1.0%
8
   1.4%
17
   1.0%
Native Hawaiian or Other Pacific Islander
1
   0.2%
4
   0.7%
0
   0.0%
5
   0.3%
Black or African American
74
  13.1%
69
  11.9%
77
  13.4%
220
  12.8%
White
464
  82.3%
482
  83.4%
474
  82.6%
1420
  82.8%
More than one race
3
   0.5%
0
   0.0%
0
   0.0%
3
   0.2%
Unknown or Not Reported
19
   3.4%
17
   2.9%
10
   1.7%
46
   2.7%
Zubrod Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 564 participants 578 participants 574 participants 1716 participants
0
522
  92.6%
539
  93.3%
540
  94.1%
1601
  93.3%
1
42
   7.4%
39
   6.7%
34
   5.9%
115
   6.7%
[1]
Measure Description: 0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, <50% in bed during the day; 3 = Symptomatic, >50% in bed, but not bedbound; 4 = Bedbound; 5 = Death
Pathologic Seminal Vesicle Involvement  
Measure Type: Count of Participants
Unit of measure:  Participants
No Number Analyzed 564 participants 578 participants 574 participants 1716 participants
482
  85.5%
494
  85.5%
488
  85.0%
1464
  85.3%
Yes Number Analyzed 564 participants 578 participants 574 participants 1716 participants
82
  14.5%
84
  14.5%
86
  15.0%
252
  14.7%
Prostatectomy Tumor Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
pT2 Number Analyzed 564 participants 578 participants 574 participants 1716 participants
292
  51.8%
317
  54.8%
304
  53.0%
913
  53.2%
pT3 Extraprostatic extension NOS Number Analyzed 564 participants 578 participants 574 participants 1716 participants
13
   2.3%
15
   2.6%
18
   3.1%
46
   2.7%
pT3a Extraprostatic extension Number Analyzed 564 participants 578 participants 574 participants 1716 participants
177
  31.4%
162
  28.0%
166
  28.9%
505
  29.4%
pT3b Seminal vesicle invasion Number Analyzed 564 participants 578 participants 574 participants 1716 participants
82
  14.5%
84
  14.5%
86
  15.0%
252
  14.7%
[1]
Measure Description: Tumor stage per the American Joint Committee on Cancer (AJCC) 6th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b.
Gleason Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
4 Number Analyzed 564 participants 578 participants 574 participants 1716 participants
0
   0.0%
1
   0.2%
1
   0.2%
2
   0.1%
5 Number Analyzed 564 participants 578 participants 574 participants 1716 participants
3
   0.5%
1
   0.2%
5
   0.9%
9
   0.5%
6 Number Analyzed 564 participants 578 participants 574 participants 1716 participants
80
  14.2%
85
  14.7%
89
  15.5%
254
  14.8%
7: 3+4 Number Analyzed 564 participants 578 participants 574 participants 1716 participants
226
  40.1%
240
  41.5%
221
  38.5%
687
  40.0%
7:4+3 Number Analyzed 564 participants 578 participants 574 participants 1716 participants
153
  27.1%
148
  25.6%
156
  27.2%
457
  26.6%
7: primary/secondary not indicated Number Analyzed 564 participants 578 participants 574 participants 1716 participants
9
   1.6%
5
   0.9%
3
   0.5%
17
   1.0%
8 Number Analyzed 564 participants 578 participants 574 participants 1716 participants
57
  10.1%
60
  10.4%
57
   9.9%
174
  10.1%
9 Number Analyzed 564 participants 578 participants 574 participants 1716 participants
36
   6.4%
38
   6.6%
42
   7.3%
116
   6.8%
[1]
Measure Description: Gleason score describes prostate cancer based on how abnormal the cancer cells in a biopsy sample look under a microscope. Cells are scored 1-5 with 1 indicating "low-grade" looking similar to normal cells and 5 indicating "high-grade" barely resembling normal cells due to mutation. A pathologist assigns a Gleason grade to the first and second most predominant patterns in the biopsy. The two grades are added together to calculate the Gleason score (between 2 and 10). Cancers with lower scores tend to be less aggressive, while cancers with higher scores end to be more aggressive.
Prostatectomy Margins  
Measure Type: Count of Participants
Unit of measure:  Participants
Positive Number Analyzed 564 participants 578 participants 574 participants 1716 participants
288
  51.1%
289
  50.0%
284
  49.5%
861
  50.2%
Negative Number Analyzed 564 participants 578 participants 574 participants 1716 participants
267
  47.3%
284
  49.1%
287
  50.0%
838
  48.8%
Unknown Number Analyzed 564 participants 578 participants 574 participants 1716 participants
9
   1.6%
5
   0.9%
3
   0.5%
17
   1.0%
Pelvic Lymphadenectomy  
Measure Type: Count of Participants
Unit of measure:  Participants
No Number Analyzed 564 participants 578 participants 574 participants 1716 participants
189
  33.5%
207
  35.8%
209
  36.4%
605
  35.3%
Yes Number Analyzed 564 participants 578 participants 574 participants 1716 participants
375
  66.5%
371
  64.2%
365
  63.6%
1111
  64.7%
Number of Lymph Nodes Examined   [1] 
Median (Full Range)
Unit of measure:  Lymph nodes
Number Analyzed 349 participants 336 participants 336 participants 1021 participants
5
(0 to 34)
6
(1 to 54)
5
(1 to 32)
6
(0 to 54)
[1]
Measure Analysis Population Description: Eligible with lymphadenectomy details
Pre-RT Entry PSA   [1] 
Median (Full Range)
Unit of measure:  Ng/ml
Number Analyzed 564 participants 578 participants 574 participants 1716 participants
0.32
(0.1 to 1.96)
0.40
(0.1 to 1.93)
0.32
(0.1 to 1.93)
0.35
(0.1 to 1.96)
[1]
Measure Description: Prostate-specific antigen (PSA) is a protein made by the prostate gland and found in the blood. PSA blood levels may be higher than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland, and are often used to monitor patients who have been treated for prostate cancer to see if their cancer has recurred.
Pre-RT Entry PSA  
Measure Type: Count of Participants
Unit of measure:  Participants
>= 0.1 and <= 0.2 ng/ml Number Analyzed 564 participants 578 participants 574 participants 1716 participants
155
  27.5%
126
  21.8%
154
  26.8%
435
  25.3%
> 0.2 and <= 0.5 ng/ml Number Analyzed 564 participants 578 participants 574 participants 1716 participants
247
  43.8%
256
  44.3%
247
  43.0%
750
  43.7%
> 0.5 and <= 1.0 ng/ml Number Analyzed 564 participants 578 participants 574 participants 1716 participants
105
  18.6%
130
  22.5%
114
  19.9%
349
  20.3%
> 1.0 and < 2.0 ng/ml Number Analyzed 564 participants 578 participants 574 participants 1716 participants
57
  10.1%
66
  11.4%
59
  10.3%
182
  10.6%
1.Primary Outcome
Title Percentage of Participants Free From Progression (FFP) at 5 Years
Hide Description Progression is defined as the first occurrence of the following events: biochemical failure by the Phoenix definition (prostate-specific antigen [PSA] ≥ 2 ng/ml over the nadir PSA), clinical failure (local, regional or distant), or death from any cause. The initiation of second salvage therapy before progression was a protocol violation and resulted in censoring. Progression time is defined as time from randomization to the date of progression, second salvage therapy (censored), or last known follow-up (censored). Freedom from progression rates are estimated using the Kaplan-Meier method. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.
Time Frame From randomization to five years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title PBRT Alone PBRT + STAD PLNRT + PBRT + STAD
Hide Arm/Group Description:
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Overall Number of Participants Analyzed 564 578 574
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70.3
(66.2 to 74.3)
81.3
(77.9 to 84.6)
87.4
(84.6 to 90.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PBRT + STAD
Comments Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments One-sided significance level = 0.001
Method Z test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBRT + STAD, PLNRT + PBRT + STAD
Comments Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Z-test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PLNRT + PBRT + STAD
Comments Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Z-test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure)
Hide Description Secondary biochemical (failure) is defined as either of two occurrences: 1. For detectable post-baseline PSA values (≥ 0.1), the first occurrence of a PSA value that is both ≥ 0.4 and a second rise above nadir; 2.The start of second salvage therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title PBRT Alone PBRT + STAD PLNRT + PBRT + STAD
Hide Arm/Group Description:
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Overall Number of Participants Analyzed 564 578 574
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35.7
(31.6 to 39.9)
22.3
(18.8 to 26.0)
14.5
(11.6 to 17.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.57
Confidence Interval (2-Sided) 97.5%
0.45 to 0.72
Estimation Comments Reference level = PBRT Alone
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBRT + STAD, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.67
Confidence Interval (2-Sided) 97.5%
0.51 to 0.89
Estimation Comments Reference level = PBRT + STAD
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.39
Confidence Interval (2-Sided) 97.5%
0.30 to 0.51
Estimation Comments Reference level = PBRT Alone
3.Secondary Outcome
Title Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease)
Hide Description Hormone-refractory disease (failure) is defined as three rises in PSA after the start of second salvage androgen deprivation therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title PBRT Alone PBRT + STAD PLNRT + PBRT + STAD
Hide Arm/Group Description:
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Overall Number of Participants Analyzed 564 578 574
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.9
(1.7 to 4.7)
2.4
(1.3 to 4.1)
1.2
(0.5 to 2.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 97.5%
0.39 to 1.39
Estimation Comments Reference level = PBRT Alone
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBRT + STAD, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.39
Confidence Interval (2-Sided) 97.5%
0.16 to 0.95
Estimation Comments Reference level = PBRT + STAD
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.29
Confidence Interval (2-Sided) 97.5%
0.12 to 0.68
Estimation Comments Reference level = PBRT Alone
4.Secondary Outcome
Title Percentage of Participants With Local Failure
Hide Description Local failure is defined as first occurrence of local clinical progression. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title PBRT Alone PBRT + STAD PLNRT + PBRT + STAD
Hide Arm/Group Description:
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Overall Number of Participants Analyzed 564 578 574
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.1
(1.8 to 4.9)
1.2
(0.5 to 2.4)
0.4
(0.1 to 1.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.37
Confidence Interval (2-Sided) 97.5%
0.14 to 1.01
Estimation Comments Reference level = PBRT Alone
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBRT + STAD, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.56
Confidence Interval (2-Sided) 97.5%
0.14 to 2.30
Estimation Comments Reference level = PBRT + STAD
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.21
Confidence Interval (2-Sided) 97.5%
0.06 to 0.71
Estimation Comments Reference level = PBRT Alone
5.Secondary Outcome
Title Percentage of Participants With Distant Metastasis
Hide Description Distant metastasis (failure) is defined as the occurrence of distant metastasis determined by imaging. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title PBRT Alone PBRT + STAD PLNRT + PBRT + STAD
Hide Arm/Group Description:
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Overall Number of Participants Analyzed 564 578 574
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.3
(6.1 to 11.0)
5.9
(4.1 to 8.2)
4.7
(3.1 to 6.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Confidence Interval (2-Sided) 97.5%
0.49 to 1.22
Estimation Comments Reference level = PBRT Alone
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBRT + STAD, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.62
Confidence Interval (2-Sided) 97.5%
0.36 to 1.06
Estimation Comments Reference level = PBRT + STAD
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.48
Confidence Interval (2-Sided) 97.5%
0.29 to 0.81
Estimation Comments Reference level = PBRT Alone
6.Secondary Outcome
Title Percentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality)
Hide Description Cause-specific mortality (failure) is defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), or death following disease progression (clinical or biochemical) in the absence of or after the initiation of any salvage therapy. [Biochemical progression is indicated by any rise in PSA.] Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title PBRT Alone PBRT + STAD PLNRT + PBRT + STAD
Hide Arm/Group Description:
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Overall Number of Participants Analyzed 564 578 574
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.7
(1.5 to 4.4)
1.1
(0.4 to 2.3)
0.8
(0.3 to 1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 97.5%
0.35 to 1.43
Estimation Comments Reference level = PBRT Alone
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBRT + STAD, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.141
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 97.5%
0.30 to 1.54
Estimation Comments Reference level = PBRT + STAD
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.47
Confidence Interval (2-Sided) 97.5%
0.21 to 1.03
Estimation Comments Reference level = PBRT Alone
7.Secondary Outcome
Title Percentage of Participants Alive (Overall Mortality)
Hide Description Survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. Pairwise comparisons of the overall distributions of failure times are reported in statistical analysis section, with five-year rates reported here. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
Time Frame From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title PBRT Alone PBRT + STAD PLNRT + PBRT + STAD
Hide Arm/Group Description:
(Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
(Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
(Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Overall Number of Participants Analyzed 564 578 574
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.9
(91.8 to 96.0)
96.1
(94.4 to 97.8)
95.7
(94.0 to 97.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.235
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 97.5%
0.54 to 1.38
Estimation Comments Reference level = PBRT Alone
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBRT + STAD, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.481
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 97.5%
0.61 to 1.60
Estimation Comments Reference level = PBRT + STAD
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PLNRT + PBRT + STAD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.213
Comments One-sided significance level = 0.0125
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 97.5%
0.53 to 1.35
Estimation Comments Reference level = PBRT Alone
8.Secondary Outcome
Title Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT)
Hide Description Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Pairwise comparisons of Arm 2 vs Arm 1 and Arm 3 vs. Arm 2 are reported in the statistical analysis.
Time Frame From randomization to 90 days after completion of radiotherapy (approximately 7-8 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title PBRT Alone PBRT + STAD PLNRT + PBRT + STAD
Hide Arm/Group Description:
Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Overall Number of Participants Analyzed 564 578 574
Measure Type: Number
Unit of Measure: percentage of participants
Grade 2+ 18.8 36.3 43.6
Grade 3+ 4.4 8.7 12.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PBRT + STAD
Comments Acute grade 2+ acute adverse events
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments One-sided significance level = 0.025
Method Regression, Logistic
Comments Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.47
Confidence Interval (2-Sided) 97.5%
1.81 to 3.37
Estimation Comments Reference level = PBRT Alone
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBRT + STAD, PLNRT + PBRT + STAD
Comments Acute grade 2+ acute adverse events
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments One-sided significance level = 0.025
Method Regression, Logistic
Comments Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.35
Confidence Interval (2-Sided) 97.5%
1.03 to 1.77
Estimation Comments Reference level = PBRT + STAD
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PBRT + STAD
Comments Acute grade 3+ acute adverse events
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments One-sided significance level = 0.025
Method Regression, Logistic
Comments Univariate model was used due to the low number of events.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.04
Confidence Interval (2-Sided) 97.5%
1.16 to 3.60
Estimation Comments Reference level = PBRT Alone
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PBRT + STAD, PLNRT + PBRT + STAD
Comments Acute grade 3+ adverse events
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments One-sided significance level = 0.025
Method Regression, Logistic
Comments Univariate model was used due to the low number of events.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
0.975 to 2.27
Estimation Comments Reference level = PBRT + STAD
9.Secondary Outcome
Title Percentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT)
Hide Description Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Late adverse events (AE) are defined as occurring > 90 days from the completion of RT. Failure time is defined as time from randomization to the date of first late grade 2 or grade 3 adverse event, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times between Arm 2 and Arm 1 and between Arm 3 and Arm 2, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored.
Time Frame AE: from 91 days after completion of RT (approximately 7-8 weeks) to last follow-up. Vital status: from randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants
Arm/Group Title PBRT Alone PBRT + STAD PLNRT + PBRT + STAD
Hide Arm/Group Description:
Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.
Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
Overall Number of Participants Analyzed 564 578 574
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Grade 2+
52.8
(48.4 to 57.0)
54.8
(50.4 to 58.9)
58.6
(54.3 to 62.6)
Grade 3+
10.3
(7.8 to 13.2)
11.4
(8.9 to 14.3)
14.4
(11.6 to 17.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PBRT + STAD
Comments Late grade 2+ adverse events
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.268
Comments One-sided significance level = 0.025
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Confidence Interval (2-Sided) 97.5%
0.88 to 1.26
Estimation Comments Reference level = PBRT Alone
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PBRT + STAD, PLNRT + PBRT + STAD
Comments Late grade 2+ adverse events
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.101
Comments One-sided significance level = 0.025
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.10
Confidence Interval (2-Sided) 97.5%
0.93 to 1.32
Estimation Comments Reference level = PBRT + STAD
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PBRT Alone, PBRT + STAD
Comments Late grade 3+ adverse events
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments One-sided significance level = 0.025
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.22
Confidence Interval (2-Sided) 97.5%
0.83 to 1.80
Estimation Comments Reference level = PBRT Alone
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PBRT + STAD, PLNRT + PBRT + STAD
Comments Late grade 3+ adverse events
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.170
Comments One-sided significance level = 0.025
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.16
Confidence Interval (2-Sided) 97.5%
0.82 to 1.65
Estimation Comments Reference level = PBRT + STAD
10.Secondary Outcome
Title Comparison of Disease-specific Health Related Quality of Life (HRQOL) Change by the Expanded Prostate Cancer Index Composite (EPIC), Hopkins Verbal Learning Test Revised (HVLT-R), Trail Making Test A & B, and Controlled Oral Word Association Test (COWAT)
Hide Description [Not Specified]
Time Frame From the 6th week of radiation therapy to 5 years post radiation therapy.
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Assessment of Mood and Depression Change Using QOL Measured by the Hopkins Symptom Checklist (HSCL-25)
Hide Description [Not Specified]
Time Frame From the 6th week of radiation therapy to 5 years post radiation therapy.
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Assessment and Comparison of Quality Adjusted Life Year (QALY) and Quality Adjusted FFP Year (QAFFPY)
Hide Description [Not Specified]
Time Frame From the 6th week of radiation therapy to 5 years post radiation therapy.
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Evaluation and Comparison of the Cost-utility Using EuroQoL - 5 Dimensions (EQ-5D)
Hide Description [Not Specified]
Time Frame From the 6th week of radiation therapy to 5 years post radiation therapy.
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints
Hide Description [Not Specified]
Time Frame Date of randomization to timepoint of the respective primary or secondary endpoint.
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Assessment of the Relationship(s) Between the American Urological Association Symptom Index (AUA SI) and Urinary Morbidity (Adverse Event Terms: Urinary Frequency/Urgency) Using the CTCAE v. 3.0 Grading System
Hide Description [Not Specified]
Time Frame From the 6th week of radiation therapy to 5 years post radiation therapy.
Outcome Measure Data Not Reported
Time Frame Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years.
Adverse Event Reporting Description Eligible participants who started study treatment and have adverse event data.
 
Arm/Group Title PBRT Alone PBRT + STADT PLNRT + PBRT + STADT
Hide Arm/Group Description Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).
All-Cause Mortality
PBRT Alone PBRT + STADT PLNRT + PBRT + STADT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   48/547 (8.78%)   43/563 (7.64%)   43/563 (7.64%) 
Hide Serious Adverse Events
PBRT Alone PBRT + STADT PLNRT + PBRT + STADT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/547 (3.29%)   29/563 (5.15%)   23/563 (4.09%) 
Blood and lymphatic system disorders       
Blood disorder * 1  0/547 (0.00%)  0/563 (0.00%)  1/563 (0.18%) 
Cardiac disorders       
Cardiac disorder * 1  0/547 (0.00%)  1/563 (0.18%)  1/563 (0.18%) 
Left ventricular failure * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
Myocardial ischemia * 1  1/547 (0.18%)  2/563 (0.36%)  0/563 (0.00%) 
Pericarditis * 1  0/547 (0.00%)  0/563 (0.00%)  1/563 (0.18%) 
Ventricular tachycardia * 1  0/547 (0.00%)  0/563 (0.00%)  1/563 (0.18%) 
Eye disorders       
Eye disorder * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
Gastrointestinal disorders       
Abdominal pain * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
Anal pain * 1  0/547 (0.00%)  0/563 (0.00%)  1/563 (0.18%) 
Colonic obstruction * 1  0/547 (0.00%)  0/563 (0.00%)  2/563 (0.36%) 
Diarrhea * 1  1/547 (0.18%)  2/563 (0.36%)  1/563 (0.18%) 
Esophageal hemorrhage * 1  0/547 (0.00%)  0/563 (0.00%)  1/563 (0.18%) 
Esophageal mucositis * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Esophagitis * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Ileus * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Pancreatitis * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
Proctitis * 1  0/547 (0.00%)  0/563 (0.00%)  1/563 (0.18%) 
Rectal hemorrhage * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Small intestinal obstruction * 1  0/547 (0.00%)  1/563 (0.18%)  1/563 (0.18%) 
General disorders       
Fatigue * 1  2/547 (0.37%)  0/563 (0.00%)  0/563 (0.00%) 
Hepatobiliary disorders       
Cholecystitis * 1  0/547 (0.00%)  0/563 (0.00%)  1/563 (0.18%) 
Infections and infestations       
Bladder infection [with unknown ANC] * 1  1/547 (0.18%)  1/563 (0.18%)  0/563 (0.00%) 
Bone infection [with unknown ANC] * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Infection [other] * 1  0/547 (0.00%)  1/563 (0.18%)  1/563 (0.18%) 
Sepsis [with unknown ANC] * 1  0/547 (0.00%)  0/563 (0.00%)  1/563 (0.18%) 
Urinary tract infection [with unknown ANC] * 1  3/547 (0.55%)  0/563 (0.00%)  0/563 (0.00%) 
Injury, poisoning and procedural complications       
Intraoperative complications * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  0/547 (0.00%)  2/563 (0.36%)  2/563 (0.36%) 
Aspartate aminotransferase increased * 1  0/547 (0.00%)  0/563 (0.00%)  1/563 (0.18%) 
Metabolism and nutrition disorders       
Dehydration * 1  0/547 (0.00%)  2/563 (0.36%)  0/563 (0.00%) 
Hyperglycemia * 1  0/547 (0.00%)  1/563 (0.18%)  1/563 (0.18%) 
Musculoskeletal and connective tissue disorders       
Bone pain * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Joint pain * 1  0/547 (0.00%)  0/563 (0.00%)  1/563 (0.18%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Treatment related secondary malignancy * 1  0/547 (0.00%)  2/563 (0.36%)  0/563 (0.00%) 
Nervous system disorders       
Ischemia cerebrovascular * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Syncope vasovagal * 1  0/547 (0.00%)  0/563 (0.00%)  1/563 (0.18%) 
Renal and urinary disorders       
Bladder hemorrhage * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Bladder obstruction * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Bladder stenosis * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Cystitis * 1  2/547 (0.37%)  4/563 (0.71%)  3/563 (0.53%) 
Hemorrhage urinary tract * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
Renal hemorrhage * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Ureteric obstruction * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
Urethral obstruction * 1  0/547 (0.00%)  2/563 (0.36%)  0/563 (0.00%) 
Urethral stricture * 1  1/547 (0.18%)  0/563 (0.00%)  0/563 (0.00%) 
Urinary frequency * 1  1/547 (0.18%)  3/563 (0.53%)  2/563 (0.36%) 
Urinary incontinence * 1  4/547 (0.73%)  1/563 (0.18%)  2/563 (0.36%) 
Urinary retention * 1  1/547 (0.18%)  1/563 (0.18%)  1/563 (0.18%) 
Urogenital disorder * 1  5/547 (0.91%)  2/563 (0.36%)  1/563 (0.18%) 
Reproductive system and breast disorders       
Erectile dysfunction * 1  1/547 (0.18%)  1/563 (0.18%)  0/563 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
Pleural effusion * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
Respiratory disorder * 1  0/547 (0.00%)  1/563 (0.18%)  1/563 (0.18%) 
Skin and subcutaneous tissue disorders       
Skin disorder * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
Vascular disorders       
Hot flashes * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
Lymphocele * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
Thrombosis * 1  0/547 (0.00%)  1/563 (0.18%)  0/563 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PBRT Alone PBRT + STADT PLNRT + PBRT + STADT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   433/547 (79.16%)   492/563 (87.39%)   509/563 (90.41%) 
Blood and lymphatic system disorders       
Hemoglobin decreased * 1  32/547 (5.85%)  73/563 (12.97%)  80/563 (14.21%) 
Gastrointestinal disorders       
Constipation * 1  54/547 (9.87%)  53/563 (9.41%)  59/563 (10.48%) 
Diarrhea * 1  110/547 (20.11%)  127/563 (22.56%)  219/563 (38.90%) 
Gastrointestinal disorder * 1  36/547 (6.58%)  36/563 (6.39%)  33/563 (5.86%) 
Hemorrhoids * 1  26/547 (4.75%)  29/563 (5.15%)  33/563 (5.86%) 
Proctitis * 1  62/547 (11.33%)  55/563 (9.77%)  66/563 (11.72%) 
Rectal hemorrhage * 1  43/547 (7.86%)  50/563 (8.88%)  48/563 (8.53%) 
General disorders       
Fatigue * 1  148/547 (27.06%)  211/563 (37.48%)  217/563 (38.54%) 
Pain [other] * 1  30/547 (5.48%)  31/563 (5.51%)  43/563 (7.64%) 
Investigations       
Alanine aminotransferase increased * 1  8/547 (1.46%)  35/563 (6.22%)  23/563 (4.09%) 
Aspartate aminotransferase increased * 1  11/547 (2.01%)  35/563 (6.22%)  20/563 (3.55%) 
Leukopenia * 1  32/547 (5.85%)  29/563 (5.15%)  40/563 (7.10%) 
Lymphopenia * 1  28/547 (5.12%)  26/563 (4.62%)  50/563 (8.88%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  30/547 (5.48%)  35/563 (6.22%)  26/563 (4.62%) 
Psychiatric disorders       
Libido decreased * 1  35/547 (6.40%)  67/563 (11.90%)  83/563 (14.74%) 
Renal and urinary disorders       
Cystitis * 1  69/547 (12.61%)  72/563 (12.79%)  71/563 (12.61%) 
Hemorrhage urinary tract * 1  36/547 (6.58%)  29/563 (5.15%)  36/563 (6.39%) 
Urinary frequency * 1  281/547 (51.37%)  333/563 (59.15%)  348/563 (61.81%) 
Urinary incontinence * 1  237/547 (43.33%)  215/563 (38.19%)  239/563 (42.45%) 
Urinary retention * 1  69/547 (12.61%)  69/563 (12.26%)  78/563 (13.85%) 
Urogenital disorder * 1  77/547 (14.08%)  64/563 (11.37%)  80/563 (14.21%) 
Reproductive system and breast disorders       
Erectile dysfunction * 1  155/547 (28.34%)  185/563 (32.86%)  202/563 (35.88%) 
Vascular disorders       
Hot flashes * 1  36/547 (6.58%)  327/563 (58.08%)  325/563 (57.73%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Three interim analyses were planned when there were 397, 794, and 1191 eligible patients with five years of potential follow-up from the randomization date. Due to findings from the third interim analysis, the data monitoring committee recommended that study results be reported early for all arms, while recognizing that the originally planned full analysis will provide additional insight for the Arm 3 vs. Arm 2 comparison.
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
Organization: NRG Oncology
Phone: 215-574-3208
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00567580    
Obsolete Identifiers: NCT01312974
Other Study ID Numbers: RTOG-0534
CDR0000577574
NCI-2009-00733 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: December 4, 2007
First Posted: December 5, 2007
Results First Submitted: February 1, 2021
Results First Posted: March 2, 2021
Last Update Posted: May 13, 2021