This Protocol is a Randomized Prospective Study Comparing Prophylactic and on Demand Sildenafil Citrate Usage Administered During and After Radiotherapy With or Without Hormone Therapy Versus Radiotherapy With or Without Hormone Therapy Alone for the Preservation of Erectile Function After Therapy for Potent Patients With Clinically Localized Prostate Cancer
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 versus radiotherapy alone for the preservation of erectile function
in potent patients with clinically localized prostate cancer. The primary objectives of this
protocol are to determine if prophylactic and on demand usage of Sildenafil Citrate can
preserve spontaneous erectile function as well as diminish the time to restoration of
erectile function in potent men receiving radiotherapy with or without hormone therapy for
localized prostate cancer. Secondary objectives of this study are: to determine whether
prophylactic and on demand use of Sildenafil Citrate during therapy may improve the
long-term response to the drug following treatment; to determine whether prophylactic and on
demand use of Sildenafil Citrate during therapy will reduce acute and late urinary effects
of radiotherapy; to determine the impact of dosimetry and radiation exposure to both the
neurovascular bundle and bulb of the penis on erectile function preservation in the study
population undergoing brachytherapy and hormone therapy; to asses the impact on quality of
life following prophylactic and on demand Sildenafil Citrate usage in the study population;
to determine the relationship between testosterone levels, erectile function and efficacy of
prophylactic and on demand Sildenafil Citrate usage in the study population.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Determine if prophylactic sildenafil citrate used before, during & after course of radiotherapy (external beam radiotherapy &/or brachytherapy w or w/o hormone therapy) can prevent loss of spontaneous erectile function 2 yrs from start of radiation tx.
2 years from start of RT
No
Michael J Zelefsky, M.D.
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
05-007
NCT00142506
February 2005
May 2014
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Memorial Sloan-Kettering Cancer Center at Basking Ridge | Basking Ridge, New Jersey 07920 |
Memorial Sloan-Kettering Cancer Center at Commack | Commack, New York 11725 |
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center | Rockville Centre, New York 11570 |
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow, New York 10591 |