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COMPLETED Phase 3

Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy

NCT00931528 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 242 participants
Start Date 2009-11
Est. Completion 2014-11
Phase Phase 3

Sponsor

Radiation Therapy Oncology Group

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00931528

The ClinicalTrials.gov registry entry for NCT00931528 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 242 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00931528 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00931528?

The interventions under investigation include: Placebo (OTHER), Tadalafil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00931528?

This trial is sponsored by Radiation Therapy Oncology Group, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial