Trial · NCT00288080
Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer
NCT00288080, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2017-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer. Trials, record NCT00288080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00288080
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer
- NCT number
- NCT00288080
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 612 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Prostate Cancer
- Interventions
- Dexamethasone, Prednisone, docetaxel, Oral antiandrogen, Radiation therapy, LHRH agonist
- First posted
- 2006-02-07
- Last updated
- 2022-06-21
- Results first posted
- 2017-01-23
- Limitations and caveats
- Due to insufficient number of events, local control analysis was not conducted.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | Four-year rates are shown. 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 the date of last contact. |
| Secondary | Biochemical Control | From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. |
| Secondary | Local Control | From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method. |
| Secondary | Distant Metastasis | From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method. |
| Secondary | Disease-free Survival | From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method. |
| Secondary | Incidence of Adverse Events | From start of treatment until the end of follow-up | Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted. |
| Secondary | The Time Interval Between Biochemical Failure and Distant Failure Respect to Testosterone Level | From date of biochemical failure to development of distant metastasis. Maximum follow-up was 12.9 years. | Biochemical failure is defined as the first of either prostate-specific antigen (PSA) failure or the initiation of salvage hormone therapy. PSA failure is defined as a rise in PSA of 2 ng/ml over the nadir PSA. Distant failure is defined as the first occurrence of distant metastasis. |
| Secondary | Validity of PSA Endpoint as a Surrogate for Overall Survival | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | Prentice's operational criteria for determining whether determining whether biochemical failure (surrogate endpoint) is a suitable endpoint for overall survival (true endpoint): 1. Treatment is prognostic for true endpoint 2. Treatment is prognostic for surrogate endpoint 3. Surrogate is prognostic for true endpoint 4. The full effect of the treatment on the true endpoint is explained by the surrogate. If any of the criteria are not met, it is concluded that biochemical failure is not a suitable surrogate for overall survival. Therefore, if any of the criteria are met, the other criteria do not do not need to be evaluated. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | Eligible patients who did not withdraw consent. | percentage of participants | NUMBER |
| SECONDARY | Biochemical Control | From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | Eligible patients who did not withdraw consent. | percentage of participants | NUMBER |
| SECONDARY | Local Control | From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | Eligible patients who did not withdraw consent | percentage of participants | NUMBER |
| SECONDARY | Distant Metastasis | From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | Eligible patients who did not withdraw consent. | percentage of participants | NUMBER |
| SECONDARY | Disease-free Survival | From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | Eligible patients who did not withdraw consent. | percentage of participants | NUMBER |
| SECONDARY | Incidence of Adverse Events | From start of treatment until the end of follow-up | Eligible patients who started protocol treatment and did not withdraw consent | percentage of participants | NUMBER |
| SECONDARY | The Time Interval Between Biochemical Failure and Distant Failure Respect to Testosterone Level | From date of biochemical failure to development of distant metastasis. Maximum follow-up was 12.9 years. | The analysis will not be done because testosterone measurement dates were not collected. | ||
| SECONDARY | Validity of PSA Endpoint as a Surrogate for Overall Survival | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. | Because the second criterion is not met, further analysis was not performed. |
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 | Androgen Suppression + Radiation Therapy | 88.7 | 95% Confidence Interval 84.3 to 91.9 | percentage of participants | |
| Overall Survival | Androgen Suppression + Radiation Therapy + Chemotherapy | 93.3 | 95% Confidence Interval 89.6 to 95.7 | percentage of participants | |
| Biochemical Control | Androgen Suppression + Radiation Therapy | 82.0 | 95% Confidence Interval 76.7 to 86.1 | percentage of participants | |
| Biochemical Control | Androgen Suppression + Radiation Therapy + Chemotherapy | 84.1 | 95% Confidence Interval 79 to 88 | percentage of participants | |
| Local Control | Androgen Suppression + Radiation Therapy | 99.2 | 95% Confidence Interval 97.0 to 99.8 | percentage of participants | |
| Local Control | Androgen Suppression + Radiation Therapy + Chemotherapy | 99.5 | 95% Confidence Interval 96.6 to 99.9 | percentage of participants | |
| Distant Metastasis | Androgen Suppression + Radiation Therapy | 2.6 | 95% Confidence Interval 1.1 to 5 | percentage of participants | |
| Distant Metastasis | Androgen Suppression + Radiation Therapy + Chemotherapy | 1.9 | 95% Confidence Interval 0.7 to 4.1 | percentage of participants | |
| Disease-free Survival | Androgen Suppression + Radiation Therapy | 73.0 | 95% Confidence Interval 67.4 to 77.9 | percentage of participants | |
| Disease-free Survival | Androgen Suppression + Radiation Therapy + Chemotherapy | 78.5 | 95% Confidence Interval 73.1 to 82.9 | percentage of 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 | Androgen Suppression + Radiation Therapy (RT) | 307 | |
| Overall Study | STARTED | Androgen Suppression + Radiation Therapy + Chemotherapy | 305 | |
| Overall Study | COMPLETED | Androgen Suppression + Radiation Therapy (RT) | 281 | |
| Overall Study | COMPLETED | Androgen Suppression + Radiation Therapy + Chemotherapy | 282 | |
| Overall Study | NOT COMPLETED | Androgen Suppression + Radiation Therapy (RT) | 26 | |
| Overall Study | NOT COMPLETED | Androgen Suppression + Radiation Therapy + Chemotherapy | 23 |
Source ClinicalTrials.gov
Adverse events332
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 | Blood/bone marrow - Other | Blood and lymphatic system disorders | Androgen Suppression + Radiation Therapy | 3 | 302 | |
| other | Blood/bone marrow - Other | Blood and lymphatic system disorders | Androgen Suppression + Radiation Therapy + Chemotherapy | 18 | 302 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Androgen Suppression + Radiation Therapy | 37 | 302 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Androgen Suppression + Radiation Therapy + Chemotherapy | 176 | 302 | |
| other | Lacrimation increased | Eye disorders | Androgen Suppression + Radiation Therapy | 2 | 302 | |
| other | Lacrimation increased | Eye disorders | Androgen Suppression + Radiation Therapy + Chemotherapy | 16 | 302 | |
| other | Abdominal pain NOS | Gastrointestinal disorders | Androgen Suppression + Radiation Therapy | 15 | 302 | |
| other | Abdominal pain NOS | Gastrointestinal disorders | Androgen Suppression + Radiation Therapy + Chemotherapy | 23 | 302 | |
| other | Constipation | Gastrointestinal disorders | Androgen Suppression + Radiation Therapy | 29 | 302 | |
| other | Constipation | Gastrointestinal disorders | Androgen Suppression + Radiation Therapy + Chemotherapy | 54 | 302 |
1 to 10 of 332Source ClinicalTrials.gov
See all 332 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Androgen Suppression + Radiation Therapy | ||
| Total, all-cause mortality | Androgen Suppression + Radiation Therapy + Chemotherapy | ||
| Total, other adverse events | Androgen Suppression + Radiation Therapy | 278 | 302 |
| Total, other adverse events | Androgen Suppression + Radiation Therapy + Chemotherapy | 289 | 302 |
| Total, serious adverse events | Androgen Suppression + Radiation Therapy | 26 | 302 |
| Total, serious adverse events | Androgen Suppression + Radiation Therapy + Chemotherapy | 93 | 302 |
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 |
|---|
| Androgen Suppression + Radiation Therapy vs Androgen Suppression + Radiation Therapy + 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/NCT00288080
GET https://conductscience.org/api/trials/v1/NCT00288080/events?page=2