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

Primary Purpose

Penile Cancer, Erectile Dysfunction, Radical Prostatectomy

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Placebo QHS and sildenafil and questionnaires

Sildenafil and questionnaire

Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires

About this trial

This is an interventional treatment trial for Penile Cancer focused on measuring Penis, PLACEBO, SILDENAFIL CITRATE, TRIMIX, Bimix, Viagra, 09-005, Erectile Dysfunction following Bilateral Nerve-Sparing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

PRN Sildenafil

Nightly Sildenafil Arm

Combination Therapy Arm

Arm Description

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.

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).

Outcomes

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.

Secondary Outcome Measures

The Time to Return of Spontaneous Functional Erections.

The Time for Patients to Respond to Oral Erectogenic Therapy.

The Proportion of Patients Who Have Normalization of Their Erectile Function (Normalization of the EF Domain of the IIEF).

Full Information

NCT ID

NCT00955929

First Posted

August 7, 2009

Last Updated

November 9, 2021

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00955929

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Terminated

Why Stopped

The study was interrupted because of failure to recruit the target study population in a reasonable timeframe.

Study Start Date

August 6, 2009 (Actual)

Primary Completion Date

December 9, 2020 (Actual)

Study Completion Date

December 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Penile Cancer, Erectile Dysfunction, Radical Prostatectomy

Keywords

Penis, PLACEBO, SILDENAFIL CITRATE, TRIMIX, Bimix, Viagra, 09-005, Erectile Dysfunction following Bilateral Nerve-Sparing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRN Sildenafil

Arm Type

Experimental

Arm Description

Arm Title

Nightly Sildenafil Arm

Arm Type

Experimental

Arm Description

Arm Title

Combination Therapy Arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Placebo QHS and sildenafil and questionnaires

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Sildenafil and questionnaire

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

The Time to Return of Spontaneous Functional Erections.

Time Frame

2 years

Title

The Time for Patients to Respond to Oral Erectogenic Therapy.

Time Frame

2 years

Title

The Proportion of Patients Who Have Normalization of Their Erectile Function (Normalization of the EF Domain of the IIEF).

Time Frame

2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Mulhall, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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