Trial · NCT00005044
Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
NCT00005044, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2017-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer. Trials, record NCT00005044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00005044
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
- NCT number
- NCT00005044
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,579 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Prostate Cancer
- Interventions
- Casodex, Eulexin, LHRH agonist, radiation therapy
- First posted
- 2003-01-27
- Last updated
- 2022-06-15
- Results first posted
- 2017-10-31
- Limitations and caveats
- The data monitoring committee decided in June 2012 after the first interim analysis that the trial should be reported early due to the low number of events.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease-specific Survival (DSS) (10-year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported. |
| Secondary | Overall Survival (OS) (10-year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Survival time is defined as time from randomization to the 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. Ten-year rate is reported. |
| Secondary | Disease-free Survival (DFS) (10-year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Disease-free survival time is defined as time from randomization to the date of disease progression or 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. Ten-year rate is reported. |
| Secondary | Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF \[protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy\], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported. |
| Secondary | Time to First Biochemical Failure (BF) (10-year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported. |
| Secondary | Time to Second Biochemical Failure (SBF) (10-year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported. |
| Secondary | Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Acute drug therapy and radiation (\<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease-specific Survival (DSS) (10-year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) (10-year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Disease-free Survival (DFS) (10-year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Eligible patients without follow-up data | percentage of participants | NUMBER |
| SECONDARY | Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Time to First Biochemical Failure (BF) (10-year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Time to Second Biochemical Failure (SBF) (10-year Rates Reported) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Eligible patients with follow-up data | percentage of participants | NUMBER |
| SECONDARY | Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient) | From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.) | Eligible patients with adverse event data in corresponding time frame (during hormone therapy and \<=90 days from RT start; \> 90 days from RT start) | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease-specific Survival (DSS) (10-year Rates Reported) | TAS x 8 Weeks | 95 | 95% Confidence Interval 93 to 97 | percentage of participants | |
| Disease-specific Survival (DSS) (10-year Rates Reported) | TAS x 28 Weeks | 96 | 95% Confidence Interval 95 to 98 | percentage of participants | |
| Overall Survival (OS) (10-year Rates Reported) | TAS x 8 Weeks | 66 | 95% Confidence Interval 62 to 70 | percentage of participants | |
| Overall Survival (OS) (10-year Rates Reported) | TAS x 28 Weeks | 67 | 95% Confidence Interval 63 to 71 | percentage of participants | |
| Disease-free Survival (DFS) (10-year Rates Reported) | TAS x 8 Weeks | 24 | 95% Confidence Interval 20 to 27 | percentage of participants | |
| Disease-free Survival (DFS) (10-year Rates Reported) | TAS x 28 Weeks | 23 | 95% Confidence Interval 20 to 27 | percentage of participants | |
| Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported) | TAS x 8 Weeks | Locoregional progression | 6 | 95% Confidence Interval 4 to 8 | percentage of participants |
| Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported) | TAS x 28 Weeks | Locoregional progression | 4 | 95% Confidence Interval 3 to 6 | percentage of participants |
| Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported) | TAS x 8 Weeks | Distant metastasis | 6 | 95% Confidence Interval 4 to 8 | percentage of participants |
| Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported) | TAS x 28 Weeks | Distant metastasis | 6 | 95% Confidence Interval 4 to 8 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAS x 8 Weeks | 790 | |
| Overall Study | STARTED | TAS x 28 Weeks | 789 | |
| Overall Study | COMPLETED | TAS x 8 Weeks | 752 | |
| Overall Study | COMPLETED | TAS x 28 Weeks | 737 | |
| Overall Study | NOT COMPLETED | TAS x 8 Weeks | 38 | |
| Overall Study | NOT COMPLETED | TAS x 28 Weeks | 52 |
Source ClinicalTrials.gov
Adverse events122
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 | Constipation | Gastrointestinal disorders | TAS x 8 Weeks | 25 | 747 | |
| other | Constipation | Gastrointestinal disorders | TAS x 28 Weeks | 42 | 735 | |
| other | Diarrhea NOS | Gastrointestinal disorders | TAS x 8 Weeks | 238 | 747 | |
| other | Diarrhea NOS | Gastrointestinal disorders | TAS x 28 Weeks | 245 | 735 | |
| other | Late RT Toxicity: Other GI: NOS | Gastrointestinal disorders | TAS x 8 Weeks | 135 | 747 | |
| other | Late RT Toxicity: Other GI: NOS | Gastrointestinal disorders | TAS x 28 Weeks | 159 | 735 | |
| other | Late RT Toxicity: Small/Large Intestine: NOS | Gastrointestinal disorders | TAS x 8 Weeks | 194 | 747 | |
| other | Late RT Toxicity: Small/Large Intestine: NOS | Gastrointestinal disorders | TAS x 28 Weeks | 196 | 735 | |
| other | Proctitis NOS | Gastrointestinal disorders | TAS x 8 Weeks | 173 | 747 | |
| other | Proctitis NOS | Gastrointestinal disorders | TAS x 28 Weeks | 164 | 735 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAS x 8 Weeks | ||
| Total, all-cause mortality | TAS x 28 Weeks | ||
| Total, other adverse events | TAS x 8 Weeks | 695 | 747 |
| Total, other adverse events | TAS x 28 Weeks | 707 | 735 |
| Total, serious adverse events | TAS x 8 Weeks | 121 | 747 |
| Total, serious adverse events | TAS x 28 Weeks | 109 | 735 |
Source ClinicalTrials.gov
Papers2
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 |
|---|
| TAS x 8 Weeks vs TAS x 28 Weeks: 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/NCT00005044
GET https://conductscience.org/api/trials/v1/NCT00005044/results?page=2