Trial · NCT00004054
Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
NCT00004054, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2015-01-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer. Trials, record NCT00004054. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00004054
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
- NCT number
- NCT00004054
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 397 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Prostate Cancer
- Interventions
- bicalutamide, estramustine phosphate sodium, etoposide, flutamide, paclitaxel, Luteinizing hormone releasing hormone [LHRH] agonist, Radiation therapy, warfarin
- First posted
- 2003-01-27
- Last updated
- 2020-10-22
- Results first posted
- 2015-01-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (5-year Rate Reported) | From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. | Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 5 years. |
| Secondary | Rate of Biochemical Failure at 5 Years | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. | Biochemical failure uses the American Society for Radiation Oncology (ASTRO) definition of prostate-specific antigen (PSA) rises on three consecutive occasions, with biochemical failure date being midway between the last non-rising PSA and the first rise in PSA. Time to biochemical failure is defined as time from randomization to biochemical failure, last known follow-up (censored), or death (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. |
| Secondary | Rate of Local Progression at 5 Years | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. | Local progression is defined as documented clinical local and/or regional progression. Time to local progression is defined as time from randomization to local progression, last known follow-up (censored), or death (competing risk). Local progression rates are estimated using the cumulative incidence method. |
| Secondary | Rate of Distant Metastasis at Five Years | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. | Distant metastasis (DM) is defined as documented metastatic disease. Time to distant metastasis is defined as time from randomization to distant metastatic disease, last known follow-up (censored), or death (competing risk). Distant metastasis rates are estimated using the cumulative incidence method. |
| Secondary | Disease-free Survival Rate at 5 Years | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. | Disease-free survival (DFS) was measured from the date of randomization to the date of documentation of progression (local, distant, biochemical failure), death, or last follow-up (censored). The Kaplan-Meier method was used to estimate DFS rates. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (5-year Rate Reported) | From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. | All randomized patients. | percentage of participants | NUMBER |
| SECONDARY | Rate of Biochemical Failure at 5 Years | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. | All randomized patients | percentage of participants | NUMBER |
| SECONDARY | Rate of Local Progression at 5 Years | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. | All randomized patients | percentage of participants | NUMBER |
| SECONDARY | Rate of Distant Metastasis at Five Years | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. | All randomized patients | percentage of participants | NUMBER |
| SECONDARY | Disease-free Survival Rate at 5 Years | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years. | All randomized patients | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (5-year Rate Reported) | Hormones and RT | 84.9 | 95% Confidence Interval 79.9 to 90 | percentage of participants | |
| Overall Survival (5-year Rate Reported) | Hormones and RT Plus Chemotherapy | 87.2 | 95% Confidence Interval 82.4 to 91.9 | percentage of participants | |
| Rate of Biochemical Failure at 5 Years | Hormones and RT | 48.0 | 95% Confidence Interval 40.7 to 54.8 | percentage of participants | |
| Rate of Biochemical Failure at 5 Years | Hormones and RT Plus Chemotherapy | 47.9 | 95% Confidence Interval 40.7 to 54.8 | percentage of participants | |
| Rate of Local Progression at 5 Years | Hormones and RT | 5.8 | 95% Confidence Interval 3.1 to 9.7 | percentage of participants | |
| Rate of Local Progression at 5 Years | Hormones and RT Plus Chemotherapy | 4.1 | 95% Confidence Interval 1.9 to 7.6 | percentage of participants | |
| Rate of Distant Metastasis at Five Years | Hormones and RT | 10.4 | 95% Confidence Interval 6.6 to 15.2 | percentage of participants | |
| Rate of Distant Metastasis at Five Years | Hormones and RT Plus Chemotherapy | 8.3 | 95% Confidence Interval 4.9 to 12.7 | percentage of participants | |
| Disease-free Survival Rate at 5 Years | Hormones and RT | 39.1 | 95% Confidence Interval 32.2 to 46.0 | percentage of participants | |
| Disease-free Survival Rate at 5 Years | Hormones and RT Plus Chemotherapy | 42.9 | 95% Confidence Interval 35.9 to 49.9 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hormones and RT | 197 | |
| Overall Study | STARTED | Hormones and RT Plus Chemotherapy | 200 | |
| Overall Study | COMPLETED | Hormones and RT | 197 | |
| Overall Study | COMPLETED | Hormones and RT Plus Chemotherapy | 200 | |
| Overall Study | NOT COMPLETED | Hormones and RT | 0 | |
| Overall Study | NOT COMPLETED | Hormones and RT Plus Chemotherapy | 0 |
Source ClinicalTrials.gov
Adverse events174
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 | Hematologic-Other | Blood and lymphatic system disorders | Hormones and RT | 1 | 197 | |
| other | Hematologic-Other | Blood and lymphatic system disorders | Hormones and RT Plus Chemotherapy | 10 | 200 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Hormones and RT | 23 | 197 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Hormones and RT Plus Chemotherapy | 145 | 200 | |
| other | Edema NOS | Cardiac disorders | Hormones and RT | 7 | 197 | |
| other | Edema NOS | Cardiac disorders | Hormones and RT Plus Chemotherapy | 31 | 200 | |
| other | Constipation | Gastrointestinal disorders | Hormones and RT | 11 | 197 | |
| other | Constipation | Gastrointestinal disorders | Hormones and RT Plus Chemotherapy | 13 | 200 | |
| other | Diarrhea NOS | Gastrointestinal disorders | Hormones and RT | 76 | 197 | |
| other | Diarrhea NOS | Gastrointestinal disorders | Hormones and RT Plus Chemotherapy | 91 | 200 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hormones and RT | ||
| Total, all-cause mortality | Hormones and RT Plus Chemotherapy | ||
| Total, other adverse events | Hormones and RT | 189 | 197 |
| Total, other adverse events | Hormones and RT Plus Chemotherapy | 198 | 200 |
| Total, serious adverse events | Hormones and RT | 6 | 197 |
| Total, serious adverse events | Hormones and RT Plus Chemotherapy | 70 | 200 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Hormones and RT vs Hormones and RT Plus Chemotherapy: serious adverse events |
Source 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/NCT00004054
GET https://conductscience.org/api/trials/v1/NCT00004054/events?page=2