Phase
Condition
Erectile Dysfunction
Impotence
Infertility
Treatment
N/AClinical Study ID
Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
To receive external beam radiation therapy and/or brachytherapy for biopsy-provenprostate cancer.
Baseline International Index of Erectile Function (IIEF) erectile function domainscore >= 17.
Patients receiving radiotherapy with hormone therapy undergoing a maximum of 9 monthsof hormone therapy will be acceptable.
Exclusion
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 wouldconstitute "routine use")
Neoadjuvant androgen deprivation therapy started more than 1 month prior to entry intostudy (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 duringsexual intercourse or unstable angina within the last 6 months.
History of myocardial infarction, coronary artery bypass graft surgery or percutaneouscoronary 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 > 100or < 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 informedconsent or comply with study instructions, would place subject at increased risk, ormight 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, asassessed by the investigator.
Study Design
Study Description
Connect with a study center
Memorial Sloan-Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey 07920
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York 11725
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10021
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York 11570
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York 10591
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.