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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142506
• Other study ID #: 05-007
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2005
• Last updated: September 19, 2017
• Start date: February 2005
• Est. completion date: April 2014

Study information

• Verified date: September 2017
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 <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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• sildenafil citrate and questionaires
Hormone therapy patients will be instructed to begin the study drug simultaneously or within 1 month of start of hormone therapy. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy.In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand open label, flexible dose fashion. Hormone patients will be offered on demand Sildenafil for approximately 15-21 months. Hormone therapy patients will complete assessments at baseline (within 4 weeks of start of study treatment) each month (only IIEF and QOL) before start of radiotherapy, at start of radiotherapy and at months 3, 6, 9, 12 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.
• placebo tablets and questionaires
Non-hormone therapy patients will be instructed to begin the study drug 3 days prior to start of radiotherapy. Patients beginning study drug anytime between 3 days before start of radiotherapy and 2 weeks after the first day of radiotherapy will also be acceptable. These patients will then continue to take the study drug for approximately 6 months following start of radiotherapy. In addition, during prophylactic phase (drug and placebo prophylactic arms) patients will have the opportunity to utilize oral 50 mg. tablets of Sildenafil Citrate in an on demand, open label, flexible dose fashion. Non-hormone patients will be offered on demand Sildenafil for approximately 12 months. Assessments (IIEF, IPSS, QOL) will be completed by non-hormone therapy patients at baseline (within 4 weeks of start of study treatment) and at approximately months 3, 6, 9, 12, 18 and 24 from start of radiotherapy. Testosterone assessments will take place at baseline, and months 12 and 24.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan-Kettering Cancer Center at Commack	Commack	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center at Mercy Medical Center	Rockville Centre	New York
United States	Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center	Sleepy Hollow	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Beth Israel Medical Center, Icahn School of Medicine at Mount Sinai, St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Erectile Dysfunction	The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).	Baseline, 6 months, 12 months, 24 months

External Links

•   Memorial Sloan-Kettering Cancer Center