Trial Outcomes & Findings for Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer (NCT NCT00002597)
NCT ID: NCT00002597
Last Updated: 2018-06-14
Results Overview
Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2028 participants
Primary outcome timeframe
From date of randomization to 10 years
Results posted on
2018-06-14
Participant Flow
Participant milestones
| Measure |
Hormone Therapy + Radiation Therapy
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
Radiation therapy alone
|
|---|---|---|
|
Overall Study
STARTED
|
1013
|
1015
|
|
Overall Study
COMPLETED
|
987
|
992
|
|
Overall Study
NOT COMPLETED
|
26
|
23
|
Reasons for withdrawal
| Measure |
Hormone Therapy + Radiation Therapy
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
Radiation therapy alone
|
|---|---|---|
|
Overall Study
Protocol Violation
|
19
|
17
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
Baseline Characteristics
Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Baseline characteristics by cohort
| Measure |
Hormone Therapy + Radiation Therapy
n=987 Participants
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
n=992 Participants
Radiation therapy alone
|
Total
n=1979 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
71 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
987 Participants
n=5 Participants
|
992 Participants
n=7 Participants
|
1979 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to 10 yearsPopulation: All eligible patients.
Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Hormone Therapy + Radiation Therapy
n=987 Participants
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
n=992 Participants
Radiation therapy alone
|
|---|---|---|
|
Overall Survival Rate (10-year)
|
61.9 percentage of patients
Interval 58.3 to 65.3
|
56.8 percentage of patients
Interval 53.2 to 60.2
|
SECONDARY outcome
Timeframe: From registration to 10 yearsPopulation: All eligible patients.
Disease-specific failure is defined as death certified as due to prostate cancer (by central review), death due to complications of treatment (irrespective of malignancy status), death from unknown causes with active malignancy, or death from unknown causes with previously documented relapse (either clinical or biochemical). Survival rates were estimated by means of cumulative incidence functions.
Outcome measures
| Measure |
Hormone Therapy + Radiation Therapy
n=987 Participants
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
n=992 Participants
Radiation therapy alone
|
|---|---|---|
|
Disease-specific Survival Rate (10 Years)
|
95.7 percentage of participants
Interval 94.3 to 97.2
|
92.6 percentage of participants
Interval 90.8 to 94.4
|
SECONDARY outcome
Timeframe: From registration to 10 yearsPopulation: All eligible patients.
Local progression defined as documented local progression as determined by clinical exam . Failure rates were estimated by means of cumulative incidence functions.
Outcome measures
| Measure |
Hormone Therapy + Radiation Therapy
n=987 Participants
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
n=992 Participants
Radiation therapy alone
|
|---|---|---|
|
Local Progression Rate (10 Years)
|
10.9 percentage of participants
Interval 8.8 to 12.9
|
16.1 percentage of participants
Interval 13.7 to 18.4
|
SECONDARY outcome
Timeframe: From registration to 10 yearsPopulation: All eligible patients.
Failure is defined as documented metastatic disease. Failure rates were estimated by means of cumulative incidence functions.
Outcome measures
| Measure |
Hormone Therapy + Radiation Therapy
n=987 Participants
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
n=992 Participants
Radiation therapy alone
|
|---|---|---|
|
Distant Failure Rate (10 Years)
|
5.5 percentage of participants
Interval 3.9 to 7.0
|
8.0 percentage of participants
Interval 6.2 to 9.8
|
SECONDARY outcome
Timeframe: From registration to 10 yearsPopulation: All eligible patients.
The Phoenix definition of biochemical failure was used - an increase in the prostate-specific antigen (PSA) level of \>2 ng per milliliter above the nadir. Failure rates were estimated by means of cumulative incidence functions.
Outcome measures
| Measure |
Hormone Therapy + Radiation Therapy
n=987 Participants
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
n=992 Participants
Radiation therapy alone
|
|---|---|---|
|
Biochemical Failure Rate (10 Years)
|
26.3 percentage of participants
Interval 23.4 to 29.2
|
41.1 percentage of participants
Interval 37.9 to 44.4
|
SECONDARY outcome
Timeframe: From registration to 10 yearsPopulation: All eligible patients.
Clinical relapse is defined as local progression or distant metastases. Failure rates were estimated by means of cumulative incidence functions.
Outcome measures
| Measure |
Hormone Therapy + Radiation Therapy
n=987 Participants
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
n=992 Participants
Radiation therapy alone
|
|---|---|---|
|
Clinical Relapse Rate (10 Years)
|
15.0 percentage of participants
Interval 12.6 to 17.3
|
21.7 percentage of participants
Interval 19.1 to 24.4
|
SECONDARY outcome
Timeframe: From registration to 10 yearsPopulation: All eligible patients.
Second biochemical relapse is as defined as follows (after initiation of salvage hormone therapy): A rise in PSA on at least two consecutive cases above the nadir (after initiation of salvage hormone therapy), with the rises in PSA exceeding 1 ng/ml above the nadir; or failure to reach 4 ng/L or less at 18 months. The rates of second biochemical relapse were estimated by means of cumulative incidence functions.
Outcome measures
| Measure |
Hormone Therapy + Radiation Therapy
n=987 Participants
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
n=992 Participants
Radiation therapy alone
|
|---|---|---|
|
Second Biochemical Relapse Rate (10 Years)
|
2.7 percentage of participants
Interval 1.6 to 3.8
|
6.1 percentage of participants
Interval 4.4 to 7.7
|
SECONDARY outcome
Timeframe: From registration to 10 yearsPopulation: All eligible patients.
Disease-free failure is defined as documentation of progression (local progression, distant failure, and biochemical failure) or death from any cause. Disease-free survival rates were estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Hormone Therapy + Radiation Therapy
n=987 Participants
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
n=992 Participants
Radiation therapy alone
|
|---|---|---|
|
Disease-free Survival Rate (10 Years)
|
51.7 percentage of participants
Interval 48.1 to 55.1
|
39.5 percentage of participants
Interval 36.1 to 42.9
|
SECONDARY outcome
Timeframe: From registration to two yearsPopulation: All eligible patients who had a repeat biopsy at 2 years.
The rate of prostate rebiopsy at two years is defined as the proportion of patients whose results are positive among all eligible patients who had a repeat biopsy at two years. The rate was estimated separately in each arm.
Outcome measures
| Measure |
Hormone Therapy + Radiation Therapy
n=439 Participants
Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
|
Radiation Therapy Alone
n=404 Participants
Radiation therapy alone
|
|---|---|---|
|
Positive Re-biopsy Rate at Two Years
|
20.2 percentage of participants
|
38.9 percentage of participants
|
Adverse Events
Neoadjuvant TAS 2 Months Before and During RT
Serious events: 33 serious events
Other events: 975 other events
Deaths: 0 deaths
Radiation Therapy Alone
Serious events: 16 serious events
Other events: 955 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neoadjuvant TAS 2 Months Before and During RT
n=1003 participants at risk
Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy
|
Radiation Therapy Alone
n=1003 participants at risk
Radiation therapy alone
|
|---|---|---|
|
Blood and lymphatic system disorders
Acute RT Toxicity: Hematologic: NOS
|
0.70%
7/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.50%
5/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hormone Toxicity: Hematologic : NOS
|
0.10%
1/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Late RT Toxicity: Hematologic: NOS
|
0.80%
8/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.30%
3/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Acute RT Toxicity: Bowel: NOS
|
0.10%
1/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Late RT Toxicity: Bowel: NOS
|
0.10%
1/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.30%
3/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Late RT Toxicity: Other GI: NOS
|
0.20%
2/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Late RT Toxicity: Other: NOS
|
0.30%
3/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Hepatobiliary disorders
Hormone Toxicity: Liver : NOS
|
0.30%
3/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Acute RT Toxicity: Bladder: NOS
|
0.40%
4/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.40%
4/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Late RT Toxicity: Bladder: NOS
|
1.2%
12/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Late RT Toxicity: Other GU: NOS
|
0.00%
0/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.10%
1/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
Neoadjuvant TAS 2 Months Before and During RT
n=1003 participants at risk
Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy
|
Radiation Therapy Alone
n=1003 participants at risk
Radiation therapy alone
|
|---|---|---|
|
Blood and lymphatic system disorders
Acute RT Toxicity: Hematologic: NOS
|
12.7%
127/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.7%
67/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hormone Toxicity: Hematologic : NOS
|
17.1%
172/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Late RT Toxicity: Hematologic: NOS
|
13.5%
135/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.9%
109/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Acute RT Toxicity: Bowel: NOS
|
43.8%
439/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
501/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Late RT Toxicity: Bowel: NOS
|
26.1%
262/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.9%
210/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Acute RT Toxicity: Other: NOS
|
13.5%
135/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
13.8%
138/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Late RT Toxicity: Other: NOS
|
8.4%
84/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.9%
99/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Hepatobiliary disorders
Hormone Toxicity: Liver : NOS
|
9.3%
93/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Acute RT Toxicity: Bladder: NOS
|
14.9%
149/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
18.9%
190/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Late RT Toxicity: Bladder: NOS
|
18.1%
182/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.6%
166/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Hormone Toxicity: Impotence : NOS
|
23.7%
238/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Late RT Toxicity: Other GU: NOS
|
6.9%
69/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.8%
78/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hormone Toxicity: Hot flashes : NOS
|
29.4%
295/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/1003
Eligible patients who received treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER