Phase 3 N=290 Randomized Double-blind Prevention

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

Prostate Cancer · Erectile Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT00142506 ↗

Enrolled (actual)

290

Serious AEs

18.3%

Results posted

Oct 2017

Primary outcome: Primary: Assessment of Erectile Dysfunction — 64; 64; 59.00; 58 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: sildenafil citrate and questionaires (Drug); placebo tablets and questionaires (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Male
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Assessment of Erectile Dysfunction	64; 64; 59.00; 58; 58.00; 51	—

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.

Eligibility 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 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00142506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.