Trial · NCT00002874
Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy
NCT00002874, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2017-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy. Trials, record NCT00002874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00002874
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy
- NCT number
- NCT00002874
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 840 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Prostate Cancer
- Interventions
- bicalutamide, radiation therapy, placebo
- First posted
- 2003-01-27
- Last updated
- 2022-06-15
- Results first posted
- 2017-08-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (12-year Rates Reported) | From date of randomization to 12 years. | Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. |
| Secondary | Non-Prostate Cancer Death (12-year Rates Reported) | From date of randomization to 12 years. | Non-prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as any death that does not fall into the following categories: death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. All other deaths are considered competing risks. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Non-Prostate cancer death" is a more accurate wording for the protocol endpoint of "non-disease-specific survival", and matches the protocol definition. |
| Secondary | Second PSA Recurrence (12-year Rates Reported) | From date of randomization to 12 years. | Second PSA recurrence (SPSAR) rates (i.e. first PSA failure on study) were estimated by the cumulative incidence method, with failure defined as the first occurrence of one of the following events: 1. Increase in PSA following protocol treatment according to the following criteria met during protocol treatment: If PSA dropped to undetectable level (\<0.2 ng/ml) during protocol treatment (PT) then failure = increase after PT to \>= 0.5 ng/ml ; If PSA decreased to a detectable level (≥ 0.2 ng/ml) during PT, then failure = increase PT of \>= 0.3 ng/ml above the lowest detectable level; If PSA did not decrease during PT then failure = increase in PSA after PT of \>= 0.5 ng/ml above entry PSA level. 2. The start of salvage hormone therapy. Patients alive without SPSAR at time of analysis were censored. Death without SPSAR was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. |
| Secondary | Third PSA Recurrence (12-year Rates Reported) | From start of salvage hormone therapy to 12 years. | Third PSA recurrence rates (i.e. second PSA failure on study) were estimated by the cumulative incidence method, with failure defined as PSA value of 0.5ng/ml or higher or any disease progression after starting salvage hormone therapy. Patients alive without third PSA recurrence at time of analysis were censored. Death without third PSA recurrence was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. |
| Secondary | PSA Complete Response at End of Protocol Treatment | End of protocol treatment, which is planned to last for two years | Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml. Note that when the study opened many institutions could not detect PSA \< 05 ng/ml. |
| Secondary | Distant Failure (12-year Rates Reported) | From date of randomization to 12 years. | Distant failure rates were estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure. Patients alive without distant metastases at time of analysis were censored. Death without distant metastasis was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. |
| Secondary | Prostate Cancer Death (12-year Rates Reported) | From date of randomization to 12 years. | Prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Prostate cancer death" is a more accurate wording for the protocol endpoint of "disease-specific survival", and matches the protocol definition. |
| Secondary | Progression-free Survival (12-year Rates Reported) | From date of randomization to 12 years. | Progress-free survival rates were estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause. Patients alive without progression at time of analysis were censored. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Progression-free Survival" is more accurate wording for the protocol endpoint of "Freedom from Progression", and matches the protocol definition. |
| Secondary | Grade 3+ Toxicity | From date of randomization to four years. | Adverse events are graded using the Cooperative Group Common Toxicity Criteria and the Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring. Grade refers to severity, assigning Grades 1 through 5 based on this general guideline: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity. Toxicities reported to have occurred within 90 days from the start of radiotherapy are reported as "Acute Radiotherapy", all later toxicities are reported as "Hormone therapy and late radiotherapy toxicity". The highest grade toxicity event per subject is counted within each of these time periods. Four-year follow-up was required of all patients; patients are followed until death. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (12-year Rates Reported) | From date of randomization to 12 years. | Eligible patients who did not withdraw consent. | percentage of participants | NUMBER |
| SECONDARY | Non-Prostate Cancer Death (12-year Rates Reported) | From date of randomization to 12 years. | Eligible patients who did not withdraw consent. | percentage of participants | NUMBER |
| SECONDARY | Second PSA Recurrence (12-year Rates Reported) | From date of randomization to 12 years. | Eligible patients who did not withdraw consent. | percentage of participants | NUMBER |
| SECONDARY | Third PSA Recurrence (12-year Rates Reported) | From start of salvage hormone therapy to 12 years. | Eligible patients who did not withdraw consent and who started salvage hormone therapy. | percentage of participants | NUMBER |
| SECONDARY | PSA Complete Response at End of Protocol Treatment | End of protocol treatment, which is planned to last for two years | Eligible patients who did not withdraw consent. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Distant Failure (12-year Rates Reported) | From date of randomization to 12 years. | Eligible patients who did not withdraw consent. | percentage of participants | NUMBER |
| SECONDARY | Prostate Cancer Death (12-year Rates Reported) | From date of randomization to 12 years. | Eligible patients who did not withdraw consent. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (12-year Rates Reported) | From date of randomization to 12 years. | Eligible patients who did not withdraw consent. | percentage of participants | NUMBER |
| SECONDARY | Grade 3+ Toxicity | From date of randomization to four years. | Eligible patients who started protocol treatment and did not withdraw consent. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (12-year Rates Reported) | Placebo | 71.3 | 95% Confidence Interval 66.5 to 76.0 | percentage of participants | |
| Overall Survival (12-year Rates Reported) | Bicalutamide | 76.3 | 95% Confidence Interval 71.9 to 80.8 | percentage of participants | |
| Non-Prostate Cancer Death (12-year Rates Reported) | Placebo | 15.3 | 95% Confidence Interval 11.8 to 19.3 | percentage of participants | |
| Non-Prostate Cancer Death (12-year Rates Reported) | Bicalutamide | 17.9 | 95% Confidence Interval 14.0 to 22.1 | percentage of participants | |
| Second PSA Recurrence (12-year Rates Reported) | Placebo | 67.9 | 95% Confidence Interval 62.7 to 72.5 | percentage of participants | |
| Second PSA Recurrence (12-year Rates Reported) | Bicalutamide | 44.0 | 95% Confidence Interval 38.8 to 49.1 | percentage of participants | |
| Third PSA Recurrence (12-year Rates Reported) | Placebo | 80.7 | 95% Confidence Interval 73.2 to 86.3 | percentage of participants | |
| Third PSA Recurrence (12-year Rates Reported) | Bicalutamide | 84.2 | 95% Confidence Interval 75.0 to 90.3 | percentage of participants | |
| PSA Complete Response at End of Protocol Treatment | Placebo | 259 | Participants | ||
| PSA Complete Response at End of Protocol Treatment | Bicalutamide | 360 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bicalutamide | 421 | |
| Overall Study | STARTED | Placebo | 419 | |
| Overall Study | COMPLETED | Bicalutamide | 376 | |
| Overall Study | COMPLETED | Placebo | 384 | |
| Overall Study | NOT COMPLETED | Bicalutamide | 45 | |
| Overall Study | NOT COMPLETED | Placebo | 35 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acute RT Toxicity: Hematologic: NOS | Blood and lymphatic system disorders | Placebo | 34 | 382 | |
| other | Acute RT Toxicity: Hematologic: NOS | Blood and lymphatic system disorders | Bicalutamide | 28 | 374 | |
| other | Hematologic: NOS | Blood and lymphatic system disorders | Placebo | 58 | 382 | |
| other | Hematologic: NOS | Blood and lymphatic system disorders | Bicalutamide | 36 | 374 | |
| other | Cardiac: NOS | Cardiac disorders | Placebo | 21 | 382 | |
| other | Cardiac: NOS | Cardiac disorders | Bicalutamide | 10 | 374 | |
| other | Acute RT Toxicity: Bowel: NOS | Gastrointestinal disorders | Placebo | 232 | 382 | |
| other | Acute RT Toxicity: Bowel: NOS | Gastrointestinal disorders | Bicalutamide | 235 | 374 | |
| other | Bowel/GI: NOS | Gastrointestinal disorders | Placebo | 192 | 382 | |
| other | Bowel/GI: NOS | Gastrointestinal disorders | Bicalutamide | 168 | 374 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Bicalutamide | ||
| Total, other adverse events | Placebo | 346 | 382 |
| Total, other adverse events | Bicalutamide | 374 | 374 |
| Total, serious adverse events | Placebo | 84 | 382 |
| Total, serious adverse events | Bicalutamide | 97 | 374 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bicalutamide vs Placebo: PSA Complete Response at End of Protocol Treatment | Trial comparisons |
| Bicalutamide vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00002874
GET https://conductscience.org/api/trials/v1/NCT00002874/events?page=2