Trial · NCT00033631
Radiation Therapy in Treating Patients With Stage II Prostate Cancer
NCT00033631, Phase 3, Completed, Radiation Therapy Oncology Group; results first posted 2017-02-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Radiation Therapy in Treating Patients With Stage II Prostate Cancer. Trials, record NCT00033631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00033631
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Radiation Therapy in Treating Patients With Stage II Prostate Cancer
- NCT number
- NCT00033631
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,534 participants, actual
- Lead sponsor
- Radiation Therapy Oncology Group
- Conditions
- Prostate Cancer
- Interventions
- 70.2 Gy 3D-CRT/IMRT, 79.2 Gy 3D-CRT/IMRT
- First posted
- 2003-01-27
- Last updated
- 2023-01-18
- Results first posted
- 2017-02-08
- Limitations and caveats
- The data monitoring committee (DMC) recommended early reporting of the trial when the third interim analysis futility boundary was crossed.
Source ClinicalTrials.gov
Registered outcomes11
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 failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years. | 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 know to be alive are censored at date of last contact. |
| Secondary | Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition | From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years. | Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact. |
| Secondary | Disease Specific Survival | From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint. | Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy. |
| Secondary | Local Progression | From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. | Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. |
| Secondary | Distant Metastases | From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. | Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. |
| Secondary | Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity | From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint | Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0 |
| Secondary | Percentage of Participants With Erectile Disfuction at 12 Months | Twelve months from randomization | The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 ("How often were you able to get an erection during sexual activity?") is scored from: none/almost never (response 0-1) or \< half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction. |
| Secondary | Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months | Baseline and 12 months from randomization | The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change \>= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM \< change \< SEM; Declined: when change \<= SEM. |
| Secondary | Quality Adjusted Survival by SQLI | From randomization to 5 years. | |
| Secondary | Tumor Control Probability | From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years. | All eligible patients who did not withdraw consent | percentage of participants | NUMBER |
| SECONDARY | Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition | From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years. | All eligible patients who did not withdraw consent | percentage of participants | NUMBER |
| SECONDARY | Disease Specific Survival | From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint. | All eligible patients who did not withdraw consent | percentage of participants | NUMBER |
| SECONDARY | Local Progression | From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. | All eligible patients who have not withdrawn consent | percentage of participants | NUMBER |
| SECONDARY | Distant Metastases | From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. | All eligible patients who have not withdrawn consent | percentage of participants | NUMBER |
| SECONDARY | Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity | From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint | Eligible patients with acute adverse event data who did not withdraw consent. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Erectile Disfuction at 12 Months | Twelve months from randomization | Eligible patients with a response of 4 or 5 (most times/almost always/always) to IIEF question 1 at baseline | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months | Baseline and 12 months from randomization | Eligible participants with baseline and 12 month SQLI | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality Adjusted Survival by SQLI | From randomization to 5 years. | This analysis will not be done because we are unable to find the required algorithm for converting SQLI scores into utilities, which is needed for quality adjusted survival analysis. | ||
| SECONDARY | Tumor Control Probability | From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults 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 | 70.2 Gy | 88.5 | 95% Confidence Interval 86.2 to 90.9 | percentage of participants | |
| Overall Survival | 79.2 Gy | 88.1 | 95% Confidence Interval 85.7 to 90.4 | percentage of participants | |
| Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition | 70.2 Gy | 40.2 | 95% Confidence Interval 36.6 to 43.7 | percentage of participants | |
| Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition | 79.2 Gy | 25.2 | 95% Confidence Interval 22.1 to 28.4 | percentage of participants | |
| Disease Specific Survival | 70.2 Gy | 1.4 | 95% Confidence Interval 0.7 to 2.5 | percentage of participants | |
| Disease Specific Survival | 79.2 Gy | 0.8 | 95% Confidence Interval 0.4 to 1.8 | percentage of participants | |
| Local Progression | 70.2 Gy | 3.5 | 95% Confidence Interval 2.3 to 5 | percentage of participants | |
| Local Progression | 79.2 Gy | 1.8 | 95% Confidence Interval 1 to 3 | percentage of participants | |
| Distant Metastases | 70.2 Gy | 3.1 | 95% Confidence Interval 2.0 to 4.6 | percentage of participants | |
| Distant Metastases | 79.2 Gy | 2.2 | 95% Confidence Interval 1.3 to 3.5 | 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 | 70.2 Gy | 769 | |
| Overall Study | STARTED | 79.2 Gy | 763 | |
| Overall Study | COMPLETED | 70.2 Gy | 751 | |
| Overall Study | COMPLETED | 79.2 Gy | 748 | |
| Overall Study | NOT COMPLETED | 70.2 Gy | 18 | |
| Overall Study | NOT COMPLETED | 79.2 Gy | 15 |
Source ClinicalTrials.gov
Adverse events60
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 | Diarrhea NOS | Gastrointestinal disorders | 70.2 Gy | 58 | 744 | |
| other | Diarrhea NOS | Gastrointestinal disorders | 79.2 Gy | 50 | 737 | |
| other | Late RT Toxicity: Bowel : NOS | Gastrointestinal disorders | 70.2 Gy | 90 | 744 | |
| other | Late RT Toxicity: Bowel : NOS | Gastrointestinal disorders | 79.2 Gy | 128 | 737 | |
| other | Late RT Toxicity: Other GI : NOS | Gastrointestinal disorders | 70.2 Gy | 90 | 744 | |
| other | Late RT Toxicity: Other GI : NOS | Gastrointestinal disorders | 79.2 Gy | 107 | 737 | |
| other | Proctitis NOS | Gastrointestinal disorders | 70.2 Gy | 33 | 744 | |
| other | Proctitis NOS | Gastrointestinal disorders | 79.2 Gy | 45 | 737 | |
| other | Fatigue | General disorders | 70.2 Gy | 51 | 744 | |
| other | Fatigue | General disorders | 79.2 Gy | 51 | 737 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 70.2 Gy | ||
| Total, all-cause mortality | 79.2 Gy | ||
| Total, other adverse events | 70.2 Gy | 714 | 744 |
| Total, other adverse events | 79.2 Gy | 704 | 737 |
| Total, serious adverse events | 70.2 Gy | 30 | 744 |
| Total, serious adverse events | 79.2 Gy | 43 | 737 |
Source ClinicalTrials.gov
Papers7
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 |
|---|
| 70.2 Gy vs 79.2 Gy: 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/NCT00033631
GET https://conductscience.org/api/trials/v1/NCT00033631/events?page=2