Trial · NCT00567580
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
NCT00567580, Phase 3, Unknown, Radiation Therapy Oncology Group; results first posted 2021-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT00567580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00567580
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT00567580
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 1,792 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Prostate Cancer
- Interventions
- PBRT, PLNRT, AA, LHRH agonist
- First posted
- 2007-12-05
- Last updated
- 2025-05-09
- Results first posted
- 2021-03-02
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Free From Progression (FFP) at 5 Years | From randomization to five years. | 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. |
| Secondary | Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure) | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | 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. |
| Secondary | Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease) | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | 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. |
| Secondary | Percentage of Participants With Local Failure | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | 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. |
| Secondary | Percentage of Participants With Distant Metastasis | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | 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. |
| Secondary | Percentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality) | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | 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. |
| Secondary | Percentage of Participants Alive (Overall Mortality) | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | 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. |
| Secondary | Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT) | From randomization to 90 days after completion of radiotherapy (approximately 7-8 weeks). | 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. |
| Secondary | Percentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT) | 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. | 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. |
| Secondary | 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) | From the 6th week of radiation therapy to 5 years post radiation therapy. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Free From Progression (FFP) at 5 Years | From randomization to five years. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure) | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease) | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Local Failure | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Distant Metastasis | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality) | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive (Overall Mortality) | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT) | From randomization to 90 days after completion of radiotherapy (approximately 7-8 weeks). | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT) | 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. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | 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) | From the 6th week of radiation therapy to 5 years post radiation therapy. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Free From Progression (FFP) at 5 Years | PBRT Alone | 70.3 | 95% Confidence Interval 66.2 to 74.3 | percentage of participants | |
| Percentage of Participants Free From Progression (FFP) at 5 Years | PBRT + STAD | 81.3 | 95% Confidence Interval 77.9 to 84.6 | percentage of participants | |
| Percentage of Participants Free From Progression (FFP) at 5 Years | PLNRT + PBRT + STAD | 87.4 | 95% Confidence Interval 84.6 to 90.3 | percentage of participants | |
| Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure) | PBRT Alone | 35.7 | 95% Confidence Interval 31.6 to 39.9 | percentage of participants | |
| Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure) | PBRT + STAD | 22.3 | 95% Confidence Interval 18.8 to 26.0 | percentage of participants | |
| Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure) | PLNRT + PBRT + STAD | 14.5 | 95% Confidence Interval 11.6 to 17.7 | percentage of participants | |
| Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease) | PBRT Alone | 2.9 | 95% Confidence Interval 1.7 to 4.7 | percentage of participants | |
| Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease) | PBRT + STAD | 2.4 | 95% Confidence Interval 1.3 to 4.1 | percentage of participants | |
| Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease) | PLNRT + PBRT + STAD | 1.2 | 95% Confidence Interval 0.5 to 2.5 | percentage of participants | |
| Percentage of Participants With Local Failure | PBRT Alone | 3.1 | 95% Confidence Interval 1.8 to 4.9 | percentage of participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PBRT Alone | 592 | |
| Overall Study | STARTED | PBRT + STAD | 602 | |
| Overall Study | STARTED | PLNRT + PBRT + STAD | 598 | |
| Overall Study | Eligible | PBRT Alone | 564 | |
| Overall Study | Eligible | PBRT + STAD | 578 | |
| Overall Study | Eligible | PLNRT + PBRT + STAD | 574 | |
| Overall Study | Eligible, Started Study Treatment, and Have Adverse Event Data | PBRT Alone | 547 | |
| Overall Study | Eligible, Started Study Treatment, and Have Adverse Event Data | PBRT + STAD | 563 | |
| Overall Study | Eligible, Started Study Treatment, and Have Adverse Event Data | PLNRT + PBRT + STAD | 563 | |
| Overall Study | COMPLETED | PBRT Alone | 564 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events240
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 | Hemoglobin decreased | Blood and lymphatic system disorders | PBRT Alone | 32 | 547 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | PBRT + STADT | 73 | 563 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | PLNRT + PBRT + STADT | 80 | 563 | |
| other | Constipation | Gastrointestinal disorders | PBRT Alone | 54 | 547 | |
| other | Constipation | Gastrointestinal disorders | PBRT + STADT | 53 | 563 | |
| other | Constipation | Gastrointestinal disorders | PLNRT + PBRT + STADT | 59 | 563 | |
| other | Diarrhea | Gastrointestinal disorders | PBRT Alone | 110 | 547 | |
| other | Diarrhea | Gastrointestinal disorders | PBRT + STADT | 127 | 563 | |
| other | Diarrhea | Gastrointestinal disorders | PLNRT + PBRT + STADT | 219 | 563 | |
| other | Gastrointestinal disorder | Gastrointestinal disorders | PBRT Alone | 36 | 547 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PBRT Alone | 48 | 547 |
| Total, all-cause mortality | PBRT + STADT | 43 | 563 |
| Total, all-cause mortality | PLNRT + PBRT + STADT | 43 | 563 |
| Total, other adverse events | PBRT Alone | 433 | 547 |
| Total, other adverse events | PBRT + STADT | 492 | 563 |
| Total, other adverse events | PLNRT + PBRT + STADT | 509 | 563 |
| Total, serious adverse events | PBRT Alone | 18 | 547 |
| Total, serious adverse events | PBRT + STADT | 29 | 563 |
| Total, serious adverse events | PLNRT + PBRT + STADT | 23 | 563 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35569466 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
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/NCT00567580
GET https://conductscience.org/api/trials/v1/NCT00567580/results?page=2