Trial · NCT00002597
Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
NCT00002597, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2017-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer. Trials, record NCT00002597. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00002597
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
- NCT number
- NCT00002597
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,028 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Prostate Cancer
- Interventions
- flutamide, Zoladex, Lupron, radiation therapy
- First posted
- 2004-02-27
- Last updated
- 2018-06-14
- Results first posted
- 2017-06-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Rate (10-year) | From date of randomization to 10 years | Overall survival (OS) was calculated from randomization to the date of death from any cause and overall survival rates were estimated by the Kaplan-Meier method. |
| Secondary | Disease-specific Survival Rate (10 Years) | From registration to 10 years | Disease-specific failure is defined as death certified as due to prostate cancer (by central review), death due to complications of treatment (irrespective of malignancy status), death from unknown causes with active malignancy, or death from unknown causes with previously documented relapse (either clinical or biochemical). Survival rates were estimated by means of cumulative incidence functions. |
| Secondary | Local Progression Rate (10 Years) | From registration to 10 years | Local progression defined as documented local progression as determined by clinical exam . Failure rates were estimated by means of cumulative incidence functions. |
| Secondary | Distant Failure Rate (10 Years) | From registration to 10 years | Failure is defined as documented metastatic disease. Failure rates were estimated by means of cumulative incidence functions. |
| Secondary | Biochemical Failure Rate (10 Years) | From registration to 10 years | The Phoenix definition of biochemical failure was used - an increase in the prostate-specific antigen (PSA) level of \>2 ng per milliliter above the nadir. Failure rates were estimated by means of cumulative incidence functions. |
| Secondary | Clinical Relapse Rate (10 Years) | From registration to 10 years | Clinical relapse is defined as local progression or distant metastases. Failure rates were estimated by means of cumulative incidence functions. |
| Secondary | Second Biochemical Relapse Rate (10 Years) | From registration to 10 years | Second biochemical relapse is as defined as follows (after initiation of salvage hormone therapy): A rise in PSA on at least two consecutive cases above the nadir (after initiation of salvage hormone therapy), with the rises in PSA exceeding 1 ng/ml above the nadir; or failure to reach 4 ng/L or less at 18 months. The rates of second biochemical relapse were estimated by means of cumulative incidence functions. |
| Secondary | Disease-free Survival Rate (10 Years) | From registration to 10 years | Disease-free failure is defined as documentation of progression (local progression, distant failure, and biochemical failure) or death from any cause. Disease-free survival rates were estimated by the Kaplan-Meier method. |
| Secondary | Positive Re-biopsy Rate at Two Years | From registration to two years | The rate of prostate rebiopsy at two years is defined as the proportion of patients whose results are positive among all eligible patients who had a repeat biopsy at two years. The rate was estimated separately in each arm. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Rate (10-year) | From date of randomization to 10 years | All eligible patients. | percentage of patients | NUMBER |
| SECONDARY | Disease-specific Survival Rate (10 Years) | From registration to 10 years | All eligible patients. | percentage of participants | NUMBER |
| SECONDARY | Local Progression Rate (10 Years) | From registration to 10 years | All eligible patients. | percentage of participants | NUMBER |
| SECONDARY | Distant Failure Rate (10 Years) | From registration to 10 years | All eligible patients. | percentage of participants | NUMBER |
| SECONDARY | Biochemical Failure Rate (10 Years) | From registration to 10 years | All eligible patients. | percentage of participants | NUMBER |
| SECONDARY | Clinical Relapse Rate (10 Years) | From registration to 10 years | All eligible patients. | percentage of participants | NUMBER |
| SECONDARY | Second Biochemical Relapse Rate (10 Years) | From registration to 10 years | All eligible patients. | percentage of participants | NUMBER |
| SECONDARY | Disease-free Survival Rate (10 Years) | From registration to 10 years | All eligible patients. | percentage of participants | NUMBER |
| SECONDARY | Positive Re-biopsy Rate at Two Years | From registration to two years | All eligible patients who had a repeat biopsy at 2 years. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival Rate (10-year) | Hormone Therapy + Radiation Therapy | 61.9 | 95% Confidence Interval 58.3 to 65.3 | percentage of patients | |
| Overall Survival Rate (10-year) | Radiation Therapy Alone | 56.8 | 95% Confidence Interval 53.2 to 60.2 | percentage of patients | |
| Disease-specific Survival Rate (10 Years) | Hormone Therapy + Radiation Therapy | 95.7 | 95% Confidence Interval 94.3 to 97.2 | percentage of participants | |
| Disease-specific Survival Rate (10 Years) | Radiation Therapy Alone | 92.6 | 95% Confidence Interval 90.8 to 94.4 | percentage of participants | |
| Local Progression Rate (10 Years) | Hormone Therapy + Radiation Therapy | 10.9 | 95% Confidence Interval 8.8 to 12.9 | percentage of participants | |
| Local Progression Rate (10 Years) | Radiation Therapy Alone | 16.1 | 95% Confidence Interval 13.7 to 18.4 | percentage of participants | |
| Distant Failure Rate (10 Years) | Hormone Therapy + Radiation Therapy | 5.5 | 95% Confidence Interval 3.9 to 7.0 | percentage of participants | |
| Distant Failure Rate (10 Years) | Radiation Therapy Alone | 8.0 | 95% Confidence Interval 6.2 to 9.8 | percentage of participants | |
| Biochemical Failure Rate (10 Years) | Hormone Therapy + Radiation Therapy | 26.3 | 95% Confidence Interval 23.4 to 29.2 | percentage of participants | |
| Biochemical Failure Rate (10 Years) | Radiation Therapy Alone | 41.1 | 95% Confidence Interval 37.9 to 44.4 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hormone Therapy + Radiation Therapy | 1,013 | |
| Overall Study | STARTED | Radiation Therapy Alone | 1,015 | |
| Overall Study | COMPLETED | Hormone Therapy + Radiation Therapy | 987 | |
| Overall Study | COMPLETED | Radiation Therapy Alone | 992 | |
| Overall Study | NOT COMPLETED | Hormone Therapy + Radiation Therapy | 26 | |
| Overall Study | NOT COMPLETED | Radiation Therapy Alone | 23 |
Source ClinicalTrials.gov
Adverse events48
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 | Acute RT Toxicity: Hematologic: NOS | Blood and lymphatic system disorders | Neoadjuvant TAS 2 Months Before and During RT | 127 | 1,003 | |
| other | Acute RT Toxicity: Hematologic: NOS | Blood and lymphatic system disorders | Radiation Therapy Alone | 67 | 1,003 | |
| other | Hormone Toxicity: Hematologic : NOS | Blood and lymphatic system disorders | Neoadjuvant TAS 2 Months Before and During RT | 172 | 1,003 | |
| other | Hormone Toxicity: Hematologic : NOS | Blood and lymphatic system disorders | Radiation Therapy Alone | 0 | 1,003 | |
| other | Late RT Toxicity: Hematologic: NOS | Blood and lymphatic system disorders | Neoadjuvant TAS 2 Months Before and During RT | 135 | 1,003 | |
| other | Late RT Toxicity: Hematologic: NOS | Blood and lymphatic system disorders | Radiation Therapy Alone | 109 | 1,003 | |
| other | Acute RT Toxicity: Bowel: NOS | Gastrointestinal disorders | Neoadjuvant TAS 2 Months Before and During RT | 439 | 1,003 | |
| other | Acute RT Toxicity: Bowel: NOS | Gastrointestinal disorders | Radiation Therapy Alone | 501 | 1,003 | |
| other | Late RT Toxicity: Bowel: NOS | Gastrointestinal disorders | Neoadjuvant TAS 2 Months Before and During RT | 262 | 1,003 | |
| other | Late RT Toxicity: Bowel: NOS | Gastrointestinal disorders | Radiation Therapy Alone | 210 | 1,003 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neoadjuvant TAS 2 Months Before and During RT | ||
| Total, all-cause mortality | Radiation Therapy Alone | ||
| Total, other adverse events | Neoadjuvant TAS 2 Months Before and During RT | 975 | 1,003 |
| Total, other adverse events | Radiation Therapy Alone | 955 | 1,003 |
| Total, serious adverse events | Neoadjuvant TAS 2 Months Before and During RT | 33 | 1,003 |
| Total, serious adverse events | Radiation Therapy Alone | 16 | 1,003 |
Source ClinicalTrials.gov
Papers4
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 |
|---|
| Neoadjuvant TAS 2 Months Before and During RT vs Radiation Therapy Alone: 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/NCT00002597
GET https://conductscience.org/api/trials/v1/NCT00002597/events?page=2