|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00931528 |
Purpose
RATIONALE: Tadalafil may help prevent erectile dysfunction 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Sexual Dysfunction |
Drug: tadalafil Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | A Randomized, Double-blind, Placebo-controlled Phase III Trial to Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in Prevention of Erectile Dysfunction in Patients Treated With Radiotherapy for Prostate Cancer |
| Estimated Enrollment: | 218 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
|
Drug: tadalafil
Given orally
|
|
Placebo Comparator: Arm II
Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
|
Other: placebo
Given orally
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Diagnosis of adenocarcinoma of the prostate within the past 6 months
Clinically negative lymph nodes established by imaging (pelvic ± abdominal CT or MRI), nodal sampling, or dissection within the past 3 months
No evidence of bone metastases on bone scan within the past 3 months
Baseline serum PSA value performed with an FDA-approved assay within the past 3 months and meets 1 of the following criteria:
Spouse or partner of these patients (optional)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 171 Study Locations| Principal Investigator: | Deborah Watkins Bruner, RN, PhD | Abramson Cancer Center of the University of Pennsylvania |
More Information
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00931528 History of Changes |
| Other Study ID Numbers: | CDR0000647146, RTOG-0831 |
| Study First Received: | June 30, 2009 |
| Last Updated: | February 19, 2012 |
| Health Authority: | United States: Federal Government |
|
sexual dysfunction stage IIB prostate cancer stage IIA prostate cancer adenocarcinoma of the prostate |
|
Prostatic Neoplasms Erectile Dysfunction Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual and Gender Disorders |
Mental Disorders Tadalafil Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses |