Clinical trial · Interventional
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life
NCT00057759CI-TRIAL-00019794completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
| Sexuality and Reproductive Issues | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| sildenafil citrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sildenafil citrate
- description
- Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.
- interventionNames
- Drug: sildenafil citrate
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo with similar "dose escalation" opportunity for 12 weeks.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Ability to obtain an erection, as measured by question 1 on the IIEF
- timeFrame
- From baseline to 12 weeks from the start of drug after crossover
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTHanisch 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
- RESULTWatkins 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
- RESULTBruner 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.