Trial · NCT01342367
Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer
NCT01342367, Not applicable, Active not recruiting, University of Chicago; results first posted 2021-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer. Trials, record NCT01342367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01342367
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer
- NCT number
- NCT01342367
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 74 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Prostate Cancer
- Interventions
- Bicalutamide, Dutasteride, Finasteride, Radiation
- First posted
- 2011-04-27
- Last updated
- 2025-06-10
- Results first posted
- 2021-10-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | Baseline, 6 months, and 24 months | Questionnaires were completed in writing by the patient. Questionnaires were administered at 1-2 months after initiation of hormonal treatment (before RT), at 3-4 months (during RT), and at 6 months after initiation of study therapy. Patients also completed questionnaires at 12, 18, and 24 months after completion of radiation therapy. Of primary interest were the baseline and 6 month and 24 month timepoints which are reported here. Scale scores could range from 0-100, with higher scores indicating better quality of life. |
| Secondary | Percentage of Participants Free From Biochemical Failure | 4 years | Increase in prostate-specific antigen (PSA) measured over time. Freedom from biochemical failure (FFBF) was defined from the time of enrollment until PSA failure occurs as defined by the Phoenix definition of a rise to 2 ng/mL above the nadir PSA value. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | Baseline, 6 months, and 24 months | score on a scale | MEAN | |
| SECONDARY | Percentage of Participants Free From Biochemical Failure | 4 years | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | SOC Cohort | Baseline | 92 | Standard Deviation 0.04 | score on a scale |
| Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | Oral ADT Group | Baseline | 89 | Standard Deviation 0.04 | score on a scale |
| Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | SOC Cohort | 6 month | 81 | Standard Deviation 0.07 | score on a scale |
| Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | Oral ADT Group | 6 month | 88 | Standard Deviation 0.07 | score on a scale |
| Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | SOC Cohort | 24 month | 83 | Standard Deviation 0.05 | score on a scale |
| Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | Oral ADT Group | 24 month | 84 | Standard Deviation 0.05 | score on a scale |
| Percentage of Participants Free From Biochemical Failure | SOC Cohort | 81 | percentage of participants | ||
| Percentage of Participants Free From Biochemical Failure | Oral ADT Group | 88 | 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 | SOC Cohort | 32 | |
| Overall Study | STARTED | Oral ADT Group | 42 | |
| Overall Study | COMPLETED | SOC Cohort | 30 | |
| Overall Study | COMPLETED | Oral ADT Group | 40 | |
| Overall Study | NOT COMPLETED | SOC Cohort | 2 | |
| Overall Study | NOT COMPLETED | Oral ADT Group | 2 |
Source ClinicalTrials.gov
Adverse events6
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 | GI Toxicity | Gastrointestinal disorders | SOC Cohort | 10 | 30 | 10 |
| other | GI Toxicity | Gastrointestinal disorders | Oral ADT Group | 12 | 40 | 12 |
| other | GU toxicity | Renal and urinary disorders | SOC Cohort | 14 | 30 | 14 |
| other | GU toxicity | Renal and urinary disorders | Oral ADT Group | 18 | 40 | 18 |
| serious | GI Toxicity | Gastrointestinal disorders | SOC Cohort | 2 | 30 | 2 |
| serious | GI Toxicity | Gastrointestinal disorders | Oral ADT Group | 2 | 40 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SOC Cohort | 8 | 30 |
| Total, all-cause mortality | Oral ADT Group | 7 | 40 |
| Total, other adverse events | SOC Cohort | 14 | 30 |
| Total, other adverse events | Oral ADT Group | 18 | 40 |
| Total, serious adverse events | SOC Cohort | 2 | 30 |
| Total, serious adverse events | Oral ADT Group | 2 | 40 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SOC Cohort vs Oral ADT Group: deaths from any cause | Trial comparisons |
| SOC Cohort vs Oral ADT Group: serious adverse events | 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/NCT01342367
GET https://conductscience.org/api/trials/v1/NCT01342367/registered