Status:
COMPLETED
Study of Sildenafil Citrate During and After Radiotherapy/Hormone Therapy for Erectile Function Versus Radiotherapy/Hormone Therapy for Prostate Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Beth Israel Medical Center
Conditions:
Prostate Cancer
Erectile Dysfunction
Eligibility:
MALE
Phase:
PHASE3
Brief 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, li...
Detailed Description
This protocol is a randomized prospective study comparing prophylactic and on demand Sildenafil Citrate usage administered during and after radiotherapy in combination with or without hormone therapy ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT00142506
Start Date
February 1 2005
End Date
April 1 2014
Last Update
October 20 2017
Active Locations (5)
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1
Memorial Sloan-Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
4
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570