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

NCT00142506 | Completed Phase 3 Results

• 1 other identifier: 05-007
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostate Cancer; Erectile Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

radiotherapy with hormones, questionaire assessments

Drug: sildenafil citrate and questionaires

2

PLACEBO COMPARATOR

radiotherapy without hormones, questionaire assessments

Drug: placebo tablets and questionaires

Interventions

sildenafil citrate and questionaires DRUG

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.

1

placebo tablets and questionaires DRUG

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.

2

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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")
• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Beth Israel Medical Center: collaborator
• St. Luke's-Roosevelt Hospital Center: collaborator

Study Sites (5)

Memorial Sloan-Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan-Kettering Cancer Center at Commack

Commack, New York, 11725, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Sleepy Hollow, New York, 10591, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: MICHAEL J ZELEFSKY
• Organization: MEMORIAL SLOAN KETTERING CANCER CENTER

zelefskm@MSKCC.ORG

+1212-639-6802

Study Officials

• Michael J Zelefsky, M.D.

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: February 1, 2005
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 20, 2017
• Results First Posted: October 20, 2017

Record last verified: 2017-09

Locations

US (5)