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), 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 your treatment, could reduce your risk of long-term erectile dysfunction.

Condition	Intervention	Phase
Prostate Cancer	Drug: Sildenafil Citrate	Phase IV

Further Study Details: 

Primary Outcomes: To determine if prophylactic sildenafil citrate used before, during and after a course of radiotherapy (external beam radiotherapy or brachytherapy) can prevent loss of spontaneous erectile function 2 yrs from the start of radiation treatment.
Secondary Outcomes: To determine if the prophylactic use of sildenafil citrate during radiotherapy may improve the long-term response to the drug following treatment.
Expected Total Enrollment:  300

This protocol is a randomized prospective study comparing prophylactic sildenafil citrate usage administered during and after radiotherapy for the preservation of erectile function versus radiotherapy alone for patients with clinically localized prostate cancer. The primary objective of this protocol is to determine if prophylactic sildenafil citrate used before, during and after a course of radiotherapy (external beam radiotherapy or brachytherapy) can prevent loss of spontaneous erectile function two years following radiation treatment. Secondary endpoints of this study include the determination whether prophylactic use of sildenafil citrate during radiotherapy may improve the long-term response to the drug following treatment. An additional endpoint will be to determine if sildenafil citrate used during a course of external beam radiotherapy or brachytherapy will reduce acute and late urinary effects from radiotherapy

To determine if prophylactic sildenafil citrate used before, during and after a course of radiotherapy (external beam radiotherapy or brachytherapy) can prevent loss of spontaneous erectile function two years from the start of radiation treatment (primary objective).

To determine if the prophylactic use of sildenafil citrate during radiotherapy may improve the long-term response to the drug following treatment (secondary objective).

To determine if sildenafil citrate used during a course of external beam radiotherapy or brachytherapy among patients will reduce acute and late urinary effects of radiotherapy (secondary objective).

Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

• To receive external beam radiation therapy and/or brachytherapy for biopsy- proven prostate cancer.
• Baseline IIEF erectile function domain score >=22.

Exclusion Criteria:

• IIEF erectile function domain score <22 pre-therapy
• Current routine use of erectogenic agents (use of agents >4 times per month would constitute “routine use”)
• Neoadjuvant androgen deprivation therapy (intake of Bicalutamide alone would not constitute exclusion from study entry)
• Non-organ confined disease
• Pre-existing Peyronie''''s disease
• Prior prostate surgery, prostate radiotherapy or cryotherapy
• Currently taking nitrate medication
• Currently taking 2 Flomax

Please refer to this study by ClinicalTrials.gov identifier  NCT00142506

Michael J. Zelefsky, M.D.      212-639-6802    zelefskm@mskcc.org

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

Michael J Zelefsky, M.D.,  Principal Investigator,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  05-007
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00142506
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06