TriangleNCT00002874 · STUDY IN CONTEXT
Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- trial label
- Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0000
- source section id
- NCT00002874-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (12-year Rates Reported)
- endpoint definition
- 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.
- time origin
- From date of randomization to 12 years.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who did not withdraw consent.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0001
- source section id
- NCT00002874-om-0001
- source outcome index
- 1
- endpoint
- Non-Prostate Cancer Death (12-year Rates Reported)
- endpoint definition
- 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.
- time origin
- From date of randomization to 12 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who did not withdraw consent.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0002
- source section id
- NCT00002874-om-0002
- source outcome index
- 2
- endpoint
- Second PSA Recurrence (12-year Rates Reported)
- endpoint definition
- 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.
- time origin
- From date of randomization to 12 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who did not withdraw consent.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0003
- source section id
- NCT00002874-om-0003
- source outcome index
- 3
- endpoint
- Third PSA Recurrence (12-year Rates Reported)
- endpoint definition
- 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.
- time origin
- From start of salvage hormone therapy to 12 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who did not withdraw consent and who started salvage hormone therapy.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0004
- source section id
- NCT00002874-om-0004
- source outcome index
- 4
- endpoint
- PSA Complete Response at End of Protocol Treatment
- endpoint definition
- 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.
- time origin
- End of protocol treatment, which is planned to last for two years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who did not withdraw consent.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0005
- source section id
- NCT00002874-om-0005
- source outcome index
- 5
- endpoint
- Distant Failure (12-year Rates Reported)
- endpoint definition
- 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.
- time origin
- From date of randomization to 12 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients who did not withdraw consent.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Placebo
- regimen
- Radiation therapy (64.8 Gy) + placebo (daily 2 years)
- analyzed count
- 394
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
- analyzed count
- 376
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Placebo
- regimen
- Radiation therapy (64.8 Gy) + placebo (daily 2 years)
- analyzed count
- 376
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
- analyzed count
- 384
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Placebo
- regimen
- Radiation therapy (64.8 Gy) + placebo (daily 2 years)
- analyzed count
- 376
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
- analyzed count
- 384
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Placebo
- regimen
- Radiation therapy (64.8 Gy) + placebo (daily 2 years)
- analyzed count
- 167
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
- analyzed count
- 111
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Placebo
- regimen
- Radiation therapy (64.8 Gy) + placebo (daily 2 years)
- analyzed count
- 376
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
- analyzed count
- 384
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Placebo
- regimen
- Radiation therapy (64.8 Gy) + placebo (daily 2 years)
- analyzed count
- 376
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Bicalutamide
- regimen
- Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
- analyzed count
- 384
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00002874-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- harm key
- EG000
- source section id
- NCT00002874-ae
- event group key
- EG000
- event group label
- Placebo
- serious affected
- 84
- serious at risk
- 382
- other affected
- 346
- other at risk
- 382
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Subjects who started protocol treatment are included. Subjects experiencing more than one of a given toxicity are counted only once for that toxicity. Adverse events were graded with a combination of the Cooperative Group Common Toxicity Criteria and RTOG Acute and Late Radiation Morbidity Scoring. Grade refers to severity of toxicity assigning Grades 1-5: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT00002874
- harm key
- EG001
- source section id
- NCT00002874-ae
- event group key
- EG001
- event group label
- Bicalutamide
- serious affected
- 97
- serious at risk
- 374
- other affected
- 374
- other at risk
- 374
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Subjects who started protocol treatment are included. Subjects experiencing more than one of a given toxicity are counted only once for that toxicity. Adverse events were graded with a combination of the Cooperative Group Common Toxicity Criteria and RTOG Acute and Late Radiation Morbidity Scoring. Grade refers to severity of toxicity assigning Grades 1-5: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice