Study of Sildenafil Citrate During and After Radiotherapy/Hormone Therapy for Erectile Function Versus Radiotherapy/Hormone Therapy for Prostate Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostate Cancer, Erectile Dysfunction

In brief

Radiation sometimes affects the ability for a person to have a normal erection. Complete loss of erections after radiation treatment can happen in 40-50% of treated patients. There are medications, like sildenafil (also known as Viagra), that can help the ability to get back erections in almost 70% of such patients. The purpose of this study is to see if taking Viagra every day starting right before, during and for about 6 months after treatment, could reduce the risk of long-term erectile dysfunction.

Key facts

Study ID

NCT00142506

Run by

Memorial Sloan Kettering Cancer Center

People needed

290

Starts

2005-02-01

Expected to finish

2014-04-01

Last updated by the study team

2017-10-20

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• To receive external beam radiation therapy and/or brachytherapy for biopsy-proven prostate cancer.
• Baseline International Index of Erectile Function (IIEF) erectile function domain score >= 17.
• Patients receiving radiotherapy with hormone therapy undergoing a maximum of 9 months of hormone therapy will be acceptable.

You may not qualify if…

• Baseline IIEF-EF (1-30) domain score of <17 pre-therapy
• Current routine use of erectogenic agents (use of agents > 4 times per month would constitute "routine use")
• Neoadjuvant androgen deprivation therapy started more than 1 month prior to entry into study (intake of Bicalutamide alone does not constitute exclusion from study entry)
• Have a clinically significant penile deformity in the opinion of the investigator (ie: Peyronie's Disease)
• Non-organ confined disease
• Prior prostate surgery or cryotherapy
• Prior prostate radiotherapy started more than 2 weeks prior to entry into study
• Currently taking 0.8mg Flomax daily
• Penile implant history
• Present at baseline with chronic angina requiring nitrates, angina occurring during sexual intercourse or unstable angina within the last 6 months.
• History of myocardial infarction, coronary artery bypass graft surgery or percutaneous coronary intervention within 90 days of baseline visit.
• History of significant cardiac conduction defect within 90 days of baseline visit.
• Exhibit systolic blood pressure > 170 or < 90 mm Hg or diastolic blood pressure > 100 or < 50 mm Hg at baseline visit or have a history of malignant hypertension
• Have any condition that would interfere with the subject's ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results
• Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia or Proscar)
• Have a history of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.

Where it is running

• Memorial Sloan-Kettering Cancer Center at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center at Commack — Commack, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center at Mercy Medical Center — Rockville Centre, New York, United States
• Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center — Sleepy Hollow, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.