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NCT00931528 · ClinicalTrials.gov registry record · Phase 3
Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy
A Phase 3 study of Prostate Cancer and Sexual Dysfunction, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 242
- Enrollment target
- 20
- Study locations
NCT00931528: Completed Phase 3 study of Prostate Cancer and Sexual Dysfunction, sponsored by Radiation Therapy Oncology Group.
NCT00931528 is a Phase 3 study of Prostate Cancer and Sexual Dysfunction that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 242 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00931528, a Phase 3 study of Prostate Cancer and Sexual Dysfunction, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 242 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Tadalafil may help prevent erectile dysfunction (ED) in patients with prostate cancer that has been treated with radiation therapy. It is not yet known whether tadalafil is more effective than a placebo in preventing erectile dysfunction. PURPOSE: This randomized phase III trial is studying tadalafil to see how well it works compared with a placebo in preventing erectile dysfunction in patients with prostate cancer treated with radiation therapy.
Primary Outcome
EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item for measuring patient-reported erectile function. Question 1 asks "How often were you able to get an erection during sexual activity?" Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lowe
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Tadalafil
Study Locations (20)
California
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- Mercy San Juan Medical Center - Carmichael
- Enloe Medical Center - Chico
- Saint Agnes Medical Center - Fresno
- Veterans Administration Long Beach Medical Center - Long Beach
- Northridge Hospital Medical Center - Northridge
- Kaiser Permanente Oakland-Broadway - Oakland
- Sutter Cancer Centers Radiation Oncology Services-Roseville - Roseville
- Radiological Associates of Sacramento - Sacramento
- Mercy General Hospital Radiation Oncology Center - Sacramento
- UCSF-Mount Zion - San Francisco
- California Pacific Medical Center - San Francisco
Arizona
- Arizona Center for Cancer Care-Peoria - Peoria
- Mayo Clinic in Arizona - Scottsdale
- Arizona Oncology Services Foundation - Scottsdale
- Arizona Oncology Associates-West Orange Grove - Tucson
Alabama
- University of Alabama at Birmingham - Birmingham
- Providence Hospital - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT00931528 record still lists
NCT00931528 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00931528 names 20 study sites across 3 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT00931528 about?
NCT00931528 is a clinical study titled "Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy". RATIONALE: Tadalafil may help prevent erectile dysfunction (ED) in patients with prostate cancer that has been treated with radiation therapy. It is not yet known whether tadalafil is more effective than a placebo in preventing erectile dysfunction. PURPOSE: This randomized phase III trial is study...
What is the current status of trial NCT00931528?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 242 participants. The study started on 2009-11. Estimated completion is 2014-11.
What conditions does trial NCT00931528 study?
This clinical trial studies the following conditions: Prostate Cancer, Sexual Dysfunction.
What interventions are being tested in trial NCT00931528?
The interventions under investigation include: Placebo (OTHER), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT00931528?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00931528 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00931528's enrollment target sits among peer trials
242 191st of 735 higher than 545 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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