Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy

Not Applicable

Terminated

Interventions: Drug: Sildenafil and questionnaire
Drug: Placebo QHS and sildenafil and questionnaires
Drug: Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires

Brief Summary: When a bilateral nerve-sparing radical prostatectomy (RP) is performed, recovery of erectile function (rigid erections) is reported for up to 80% of patients, who are less than 60 years old. Erectile function recovery is also impacted by patient age, erectile function before surgery, and the length of time after surgery.

Current evidence from studies suggests that developing erections is important, however, these studies have been small, and the evidence is not definite. Animal studies suggest that erection medication (Viagra, Levitra, Cialis) may protect erection tissue, even in the absence of erections. However, the correct treatment plan is unknown. For example, how often does a man need to take sildenafil (Viagra®) to protect his erectile function or to maximize his erectile function recovery? Is only using erection medication enough for erectile function recovery? Would penile injections, which almost ensure production of an erection, be better than using sildenafil (Viagra®), or might a combination be even better at helping recovery of erections? These are types of questions this study might answer.

Recruitment & Eligibility

Inclusion Criteria

Male, must be ≥ 18 years of age, with histologically confirmed prostate adenocarcinoma, that is clinically localized to the prostate gland
Stable sexual relationship for ≥ 6 months
Open or laparoscopic bilateral nerve-sparing radical prostatectomy
Baseline score of ≥ 22 on the International Index of Erectile Function Domain (Appendix A)
Able to speak, read and write in the English language
Calculated creatinine clearance using the 4 variable MDRD equation based on serum creatinine, age, race, and gender of > 60 cc/min
Patient is able to walk up two flights of stairs briskly without chest pain
Patient needs to have their baseline sitting AND standing blood pressure and pulse done at the time of consent

Exclusion Criteria

Preoperative or planned postoperative pelvic radiation therapy
Preoperative or planned postoperative androgen deprivation
Presence of Peyronie's disease at baseline
Presence of a penile prosthesis at baseline
Resection of one or both nerve bundles at surgery
Any contraindications to sildenafil:
- Patient is currently using nitrates;
- Presence of retinitis pigmentosa;
- Presence macular degeneration;
- MI or CVA within 3 months;
- Patient is currently using MAOI medications
Patient is currently using penile self injection medication (Trimix, Bimix, or PGE-1)
Patient requiring sildenafil for penetration
Use of sildenafil within 30 days of consent

Arm && Interventions

Group	Intervention	Description
Nightly Sildenafil Arm	Sildenafil and questionnaire	Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery.
PRN Sildenafil	Placebo QHS and sildenafil and questionnaires	Placebo QHS (blinded) and sildenafil 100mgs (open-label) as required for sexual relations. The placebo will be omitted on nights that 100mgs is used. Placebo will start within 24-48 hours post-surgery.
Combination Therapy Arm	Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires	Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL), at initial dose of 5 units (0.05ml) will be given; the first 2 injections will be done in the MSKCC urology outpatient clinic (if needed, the investigator can determine appropriate amount of injections for patient training).

Primary Outcome Measures

Name	Time	Method
Difference in the Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF) Between the 3 Groups at 24 Months.	2 years

Secondary Outcome Measures

Name	Time	Method
The Proportion of Patients Who Have Normalization of Their Erectile Function (Normalization of the EF Domain of the IIEF).	2 years
The Time for Patients to Respond to Oral Erectogenic Therapy.	2 years
The Time to Return of Spontaneous Functional Erections.	2 years

Locations (1): Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States