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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Beth Israel Medical Center; Icahn School of Medicine at Mount Sinai; St. Luke's-Roosevelt Hospital Center
• Treatments: Citric Acid; Hormones; Sildenafil Citrate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.