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

NCT00931528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2018-02-14

Study results available
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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.

Conditions

Interventions

DRUG

Tadalafil

Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.

OTHER

Placebo

Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    collaborator OTHER

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Deborah Watkins Bruner, RN, PhD · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-12-31
Completion
2014-11-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00931528 on ClinicalTrials.gov