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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	Pfizer
Information provided by (Responsible Party):	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00955929

Purpose

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.

Condition	Intervention
Penile Cancer Erectile Dysfunction Radical Prostatectomy	Drug: Placebo QHS and sildenafil and questionnaires Drug: Sildenafil and questionnaire Drug: Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized Trial of Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Erectile Dysfunction Rehabilitation

Drug Information available for: Sildenafil Sildenafil citrate Alprostadil

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Difference in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) between the 3 groups at 24 months post-RP. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The time to return of spontaneous functional erections. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The time for patients to respond to oral erectogenic therapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The proportion of patients who have normalization of their erectile function (normalization of the EF domain of the IIEF). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PRN Sildenafil 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.	Drug: Placebo QHS and sildenafil and questionnaires Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
Experimental: Nightly Sildenafil Arm 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.	Drug: 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. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window
Experimental: Combination Therapy Arm 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).	Drug: Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires Intracavernous injections of a trimix combination (Papaverine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL) will be injected three times a week, and sildenafil 50mg taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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
Testosterone level of > 300 ng/dL within 90 days of surgery
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955929

Contacts

Contact: John Mulhall, MD	646-422-4359
Contact: Peter Scardino, MD

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: John Mulhall, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Pfizer

Investigators

Principal Investigator:

John Mulhall, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00955929 History of Changes
Other Study ID Numbers:	09-005
Study First Received:	August 7, 2009
Last Updated:	January 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Penis
PLACEBO
SILDENAFIL CITRATE
TRIMIX

Viagra
09-005
Erectile Dysfunction following Bilateral Nerve-Sparing

Additional relevant MeSH terms:

Penile Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Penile Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Alprostadil

Sildenafil
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012