Trial · NCT00936390
Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer
NCT00936390, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2022-10-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer. Trials, record NCT00936390. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00936390
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer
- NCT number
- NCT00936390
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,538 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Prostate Cancer
- Interventions
- bicalutamide, flutamide, LHRH agonist (antagonist) therapy, Dose-Escalated Radiation Therapy
- First posted
- 2009-07-10
- Last updated
- 2026-03-06
- Results first posted
- 2022-10-06
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Alive (Overall Survival) | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. |
| Secondary | Percentage of Participants With Biochemical Failure | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Biochemical failure is defined as an increase of at least 2 ng/ml above the nadir PSA. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. |
| Secondary | Percentage of Participants With Local Recurrence | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Local recurrence (failure) is defined as clinical (palpable) suspicion of local recurrence \[this date is used\] confirmed by biopsy. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. |
| Secondary | Percentage of Participants With Regional Recurrence | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.3 years. | Regional recurrence is defined as the documented progression in pelvic lymph nodes. If discovered on image of the pelvis prompted by a biochemical failure, then the event date would be the date of documented biochemical failure. |
| Secondary | Percentage of Participants With Distant Metastasis | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Distant metastasis (failure) is defined as metastatic disease documented by any method. If diagnosed on diagnostic imaging prompted by biochemical failure, then the event date will be the date of biochemical progression. Failure time is defined as time from randomization to the date of first failure, last known follow-up (competing risk), or death without failure (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. |
| Secondary | Percentage of Participants Dead Due to Prostate Cancer (Prostate Cancer-specific Mortality) | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Prostate cancer specific mortality (failure) is defined as death due to prostate cancer or a complication from treatment. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. |
| Secondary | Percentage of Participants Dead Due to Cause Other Than Prostate Cancer (Non-Prostate Cancer-specific Mortality) | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Non-prostate cancer specific mortality is defined as a death without evidence of prostate cancer or a complication from treatment. . Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. |
| Secondary | Percentage of Participants Receiving Salvage Androgen Deprivation Therapy (ADT) | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Salvage (non-protocol) ADT administration is defined as the first administration of subsequent ADT (either LHRH agonist or anti-androgen) Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Salvage ADT rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of salvage ADT times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. |
| Secondary | Percentage of Participants Alive (Overall Survival) by Radiation Therapy Modality | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. |
| Secondary | Number of Participants With Acute Adverse Events | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. | Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Acute adverse events are defined as occuring within 30 days of completion of radiation therapy. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Alive (Overall Survival) | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Biochemical Failure | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Local Recurrence | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Regional Recurrence | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.3 years. | Regional recurrence data was not collected and therefore cannot be reported. | ||
| SECONDARY | Percentage of Participants With Distant Metastasis | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Dead Due to Prostate Cancer (Prostate Cancer-specific Mortality) | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Dead Due to Cause Other Than Prostate Cancer (Non-Prostate Cancer-specific Mortality) | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Receiving Salvage Androgen Deprivation Therapy (ADT) | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Eligible participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive (Overall Survival) by Radiation Therapy Modality | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. | Eligible participants with radiation treatment data. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Acute Adverse Events | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. | Eligible participants who started protocol treatment and have adverse event data | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group85
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Alive (Overall Survival) | Dose-Escalated Radiation Therapy Alone | 90.0 | 95% Confidence Interval 87.7 to 92.2 | percentage of participants | |
| Percentage of Participants Alive (Overall Survival) | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 91.0 | 95% Confidence Interval 88.8 to 93.1 | percentage of participants | |
| Percentage of Participants With Biochemical Failure | Dose-Escalated Radiation Therapy Alone | 13.9 | 95% Confidence Interval 11.5 to 16.6 | percentage of participants | |
| Percentage of Participants With Biochemical Failure | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 7.7 | 95% Confidence Interval 5.9 to 9.9 | percentage of participants | |
| Percentage of Participants With Local Recurrence | Dose-Escalated Radiation Therapy Alone | 2.6 | 95% Confidence Interval 1.6 to 4.1 | percentage of participants | |
| Percentage of Participants With Local Recurrence | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 0.6 | 95% Confidence Interval 0.2 to 1.5 | percentage of participants | |
| Percentage of Participants With Distant Metastasis | Dose-Escalated Radiation Therapy Alone | 3.1 | 95% Confidence Interval 2.0 to 4.6 | percentage of participants | |
| Percentage of Participants With Distant Metastasis | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 0.6 | 95% Confidence Interval 0.2 to 1.4 | percentage of participants | |
| Percentage of Participants Dead Due to Prostate Cancer (Prostate Cancer-specific Mortality) | Dose-Escalated Radiation Therapy Alone | 0.90 | 95% Confidence Interval 0.4 to 1.9 | percentage of participants | |
| Percentage of Participants Dead Due to Prostate Cancer (Prostate Cancer-specific Mortality) | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose-Escalated Radiation Therapy Alone | 771 | |
| Overall Study | STARTED | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 767 | |
| Overall Study | Eligible | Dose-Escalated Radiation Therapy Alone | 750 | |
| Overall Study | Eligible | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 742 | |
| Overall Study | Eligible, started protocol treatment, has adverse event data | Dose-Escalated Radiation Therapy Alone | 733 | |
| Overall Study | Eligible, started protocol treatment, has adverse event data | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 725 | |
| Overall Study | Eligible with radiation treatment data | Dose-Escalated Radiation Therapy Alone | 725 | |
| Overall Study | Eligible with radiation treatment data | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 707 | |
| Overall Study | Eligible and consented to quality of life component | Dose-Escalated Radiation Therapy Alone | 215 | |
| Overall Study | Eligible and consented to quality of life component | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 205 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events182
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 | Dose-Escalated Radiation Therapy Alone | 30 | 733 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 74 | 725 | |
| other | Constipation | Gastrointestinal disorders | Dose-Escalated Radiation Therapy Alone | 86 | 733 | |
| other | Constipation | Gastrointestinal disorders | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 96 | 725 | |
| other | Diarrhea | Gastrointestinal disorders | Dose-Escalated Radiation Therapy Alone | 134 | 733 | |
| other | Diarrhea | Gastrointestinal disorders | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 186 | 725 | |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Dose-Escalated Radiation Therapy Alone | 72 | 733 | |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 77 | 725 | |
| other | Hemorrhoids | Gastrointestinal disorders | Dose-Escalated Radiation Therapy Alone | 43 | 733 | |
| other | Hemorrhoids | Gastrointestinal disorders | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 47 | 725 |
1 to 10 of 182Source ClinicalTrials.gov
See all 182 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose-Escalated Radiation Therapy Alone | 119 | 750 |
| Total, all-cause mortality | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 100 | 742 |
| Total, other adverse events | Dose-Escalated Radiation Therapy Alone | 597 | 733 |
| Total, other adverse events | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 647 | 725 |
| Total, serious adverse events | Dose-Escalated Radiation Therapy Alone | 20 | 733 |
| Total, serious adverse events | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 33 | 725 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37104748 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dose-Escalated Radiation Therapy Alone vs Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation: Number of Participants With Acute Adverse Events | Trial comparisons |
| Dose-Escalated Radiation Therapy Alone vs Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation: deaths from any cause | Trial comparisons |
| Dose-Escalated Radiation Therapy Alone vs Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation: 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/NCT00936390
GET https://conductscience.org/api/trials/v1/NCT00936390/registered?page=2