Back to results

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

Primary Purpose

Prostate Cancer, Erectile Dysfunction

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

sildenafil citrate and questionaires

placebo tablets and questionaires

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate Cancer, Cancer of the Prostate, Prostate Neoplasms, Prostatic Cancer, Viagra, 05-007

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Memorial Sloan-Kettering Cancer Center at Basking Ridge
Memorial Sloan-Kettering Cancer Center at Commack
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

radiotherapy with hormones, questionaire assessments

radiotherapy without hormones, questionaire assessments

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT00142506

First Posted

August 31, 2005

Last Updated

September 19, 2017

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Icahn School of Medicine at Mount Sinai, Beth Israel Medical Center, St. Luke's-Roosevelt Hospital Center

1. Study Identification

Unique Protocol Identification Number

NCT00142506

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Icahn School of Medicine at Mount Sinai, Beth Israel Medical Center, St. Luke's-Roosevelt Hospital Center

4. Oversight

5. Study Description

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, 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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Erectile Dysfunction

Keywords

Prostate Cancer, Cancer of the Prostate, Prostate Neoplasms, Prostatic Cancer, Viagra, 05-007

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

290 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

radiotherapy with hormones, questionaire assessments

Arm Title

Arm Type

Placebo Comparator

Arm Description

radiotherapy without hormones, questionaire assessments

Intervention Type

Drug

Intervention Name(s)

sildenafil citrate and questionaires

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo tablets and questionaires

Intervention Description

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.

Primary Outcome Measure Information:

Title

Assessment of Erectile Dysfunction

Description

Time Frame

Baseline, 6 months, 12 months, 24 months

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael J Zelefsky, M.D.

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan-Kettering Cancer Center at Basking Ridge

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center at Commack

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center

City

Rockville Centre

State/Province

New York

ZIP/Postal Code

11570

Country

United States

Facility Name

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

City

Sleepy Hollow

State/Province

New York

ZIP/Postal Code

10591

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs