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

NCT00955929

Last updated date
Study Location
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Penile Cancer, Erectile Dysfunction, Radical Prostatectomy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Penile Cancer, Erectile Dysfunction, Radical ProstatectomyPharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy
NCT00955929
  1. New York, New York
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy
Official Title  ICMJE A Randomized Trial of Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Penile Cancer
  • Erectile Dysfunction
  • Radical Prostatectomy
Intervention  ICMJE
  • 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.
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebo QHS and sildenafil and questionnaires
  • 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.
    Intervention: Drug: Sildenafil and questionnaire
  • 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).
    Intervention: Drug: Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2009)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Italy
 
Administrative Information
NCT Number  ICMJE NCT00955929
Other Study ID Numbers  ICMJE 09-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:John Mulhall, MDMemorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP