Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

NCT00057759 | Completed DMC

• 3 other identifiers: RTOG-0215CDR0000269135NCI-P-02-0234
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 30

Brief Summary

RATIONALE: Sildenafil may be effective in helping patients who have undergone treatment for prostate cancer to have an erection for sexual activity and may improve sexual satisfaction and quality of life. PURPOSE: Randomized clinical trial to study the effectiveness of sildenafil in treating erectile dysfunction in patients who have undergone radiation therapy and hormone therapy for prostate cancer in clinical trial RTOG-9910.

Conditions

Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment; Radiation Toxicity; Sexual Dysfunction; Sexuality and Reproductive Issues

Keywords

sexual dysfunction; sexuality and reproductive issues; radiation toxicity; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; psychosocial effects of cancer and its treatment

Outcome Measures

Primary Outcomes (1)

• Ability to obtain an erection, as measured by question 1 on the IIEF

  From baseline to 12 weeks from the start of drug after crossover

Secondary Outcomes (4)

• Overall sexual function and satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)

  From baseline to 12 weeks from the start of drug after crossover

• Partner sexual satisfaction as measured by the SAQ-Partner

  From baseline to 12 weeks from the start of drug after crossover

• Patient and spouse marital adjustment as measured by the Locke's Marital Adjustment Test

  From baseline to 12 weeks from the start of drug after crossover

• Predictors of erectile dysfunction therapy

  From baseline to 12 weeks from the start of drug after crossover

Study Arms (2)

Sildenafil citrate

EXPERIMENTAL

Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.

Drug: sildenafil citrate

Placebo

PLACEBO COMPARATOR

Placebo with similar "dose escalation" opportunity for 12 weeks.

Other: Placebo

Interventions

sildenafil citrate DRUG

Sildenafil citrate

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Prior treatment on RTOG-9910 for intermediate relapse-risk stage II or III prostate cancer as determined by any of the following combinations of factors: * T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10 ng/mL but no greater than 100 ng/mL * T1b-4, Gleason score 7, and PSA less than 20 ng/mL * T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL * Radiotherapy completed within the past 6 months to 5 years * Pretreatment (before enrollment on this study) erectile dysfunction as measured by International Index of Erectile Function Question #1 * Erectile dysfunction before starting prostate cancer therapy allowed * Patients without partners or without partners willing to participate allowed PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No myocardial infarction within the past year Other * No other invasive cancer within the past 5 years except localized basal cell or squamous cell skin cancer (stage 0-II) * No anatomical genital abnormalities or concurrent conditions that would prohibit sexual intercourse or preclude study participation * No other major medical or psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * More than 6 months since prior androgen suppression (e.g., leuprolide or goserelin), antiandrogen (e.g., bicalutamide, flutamide, or nilutamide), or estrogenic (e.g., diethylstilbestrol) agents Radiotherapy * See Disease Characteristics Surgery * No prior penile implant * No prior bilateral orchiectomy Other * No concurrent sildenafil * No concurrent participation in another medical research study to treat prostate cancer * No concurrent organic nitrate or requirement for nitrates (e.g., nitroglycerin as needed) * No concurrent ketoconazole, itraconazole, or erythromycin * No concurrent use of mechanical (vacuum) devices or intracorporeal, intraurethral, topical, or oral agents for erectile dysfunction

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (30)

Mount Diablo Regional Cancer Center

Concord, California, 94524-4110, United States

Location

Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital

Inglewood, California, 90301, United States

Location

John Muir/Mt. Diablo Comprehensive Cancer Center

Walnut Creek, California, 94598, United States

Location

Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Washoe Cancer Services at Washoe Medical Center - Reno

Reno, Nevada, 89502, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Fox Chase Virtua Health Cancer Program - Marlton

Marlton, New Jersey, 08053, United States

Location

Community Regional Cancer Center at Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

Salem, Ohio, 44460, United States

Location

Cancer Treatment Center

Wooster, Ohio, 44691, United States

Location

LaFortune Cancer Center at St. John Medical Center

Tulsa, Oklahoma, 74104, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Community Memorial Hospital

Menomonee Falls, Wisconsin, 53051, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

Related Publications (3)

• Hanisch LJ, Bryan CJ, James JL, Pisansky TM, Corbett TB, Parliament MB, Stewart CE, Hartford AC, Sandler H, Berk LB, Kachnic L, Bruner DW. Impact of sildenafil on marital and sexual adjustment in patients and their wives after radiotherapy and short-term androgen suppression for prostate cancer: analysis of RTOG 0215. Support Care Cancer. 2012 Nov;20(11):2845-50. doi: 10.1007/s00520-012-1409-8. Epub 2012 Feb 22.

  PMID: 22354624 RESULT

• Watkins Bruner D, James JL, Bryan CJ, Pisansky TM, Rotman M, Corbett T, Speight J, Byhardt R, Sandler H, Bentzen S, Kachnic L, Berk L. Randomized, double-blinded, placebo-controlled crossover trial of treating erectile dysfunction with sildenafil after radiotherapy and short-term androgen deprivation therapy: results of RTOG 0215. J Sex Med. 2011 Apr;8(4):1228-38. doi: 10.1111/j.1743-6109.2010.02164.x. Epub 2011 Jan 14.

  PMID: 21235716 RESULT

• Bruner DW, James J, Pisansky TM, et al.: RTOG 0215 treatment of erectile dysfunction (ED) in patients treated with neoadjuvant and concurrent androgen deprivation (AD) and radiotherapy (RT) for prostate cancer (PC). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-52, S30, 2007.

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries; Sexual Dysfunction, Physiological; Sexuality

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; Wounds and Injuries; Sexual Behavior; Behavior

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

Study Officials

• Deborah Watkins Bruner, RN, PhD

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: January 1, 2003
• Primary Completion: December 1, 2006
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

US (30)