Improving Erectile Function and Quality of Life After Prostate Cancer Treatment

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a research study of erectile dysfunction (ED) in men diagnosed with prostate cancer. 144 patients and partners will participate in the study. The purpose of this study is to test a new treatment that combines a cognitive-behavioral intervention with medication and a vacuum constrictive device to treat ED. This new treatment consists of multiple therapeutic elements that enhance compliance with medical treatment and increase sexual activity through enhancement of the sensual pleasure of sex and partner support.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborators: The Cleveland Clinic; University Hospitals Cleveland Medical Center
• Treatments: Citric Acid; Sildenafil Citrate

Criteria

Inclusion Criteria:

• Stage I, II, and III prostate cancer

• Having completed definite treatment of localized prostate cancer (surgery or radiation);

• Presence of erectile dysfunction symptoms;

• Have a stable partner for six months who is willing to participate;

• Sexually active prior to cancer treatment (≥17 on the Sexual Health Inventory For Men- ("SHIM")).

• Prostatectomy with or without radiation for the pilot study patients only.

Exclusion Criteria:

• Receiving hormonal treatment;

• Cognitive impairment (≥5 on the Short Portable Mental Status Questionnaire (SPMSQ));

• Severe marital maladjustment that prevents a patient from benefiting from the proposed intervention (<85 on the Locke-Wallace Marital Adjustment Test);

• Taking nitrates of any kind;

• Congenital bleeding disorder or predisposition to priapism that is contraindicative to VCD use;

• Having untreated clinical depression and other psychotic mental disorders (e.g., bipolar, schizophrenia) (≥27 on the Center for Epidemiological Studies Depression Scale (CES-D)).

• Patients taking any potent inhibitor of cytochrome P450 3A4 (e.g., ketoconazole, itraconazole, erythromycin, etc).

• Patients taking concomitant alpha-adrenergic blocking agents.

• Patients with a clinically significant abnormality on screening ECG (taken within 12 weeks) that in the opinion of the investigator/co-investigator may increase the patient's cardiovascular risk in this study.

• Patients with a history of left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis).

• Patients with a history of severely impaired autonomic control of blood pressure.

• Patients with resting hypotension (BP < 90/50 mm Hg), or resting hypertension (BP > 170/110 mm Hg) at Screening.

• Patients with known hypersensitivity to Sildenafil or other ingredients of Sildenafil.

• Patients with retinitis pigmentosa.

• Patients with active peptic ulceration.

• Patients who have previously experienced non-arteritic ischemic optic neuropathy (NAION).

• Patients taking other phosphodiesterase Type 5 (PDE5) inhibitors.

• Patients taking Coumadin, Pradaxa or other blood thinner drugs.