Recruiting

PRP-NR

Sponsor:

Sir Mortimer B. Davis - Jewish General Hospital

Code:

NCT07188064

Conditions

Prostate Cancer

Erectile Dysfunction Following Radical Prostatectomy

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Post radical prostatectomy nerve restoration procedure (PRP-NR)

Study Details

Brief summary:

A single arm prospective pilot trial evaluating the 1-year erectile recovery outcomes and the safety of patients undergoing a somatic to autonomic nerve grafting procedure for restoration of erectile function in patients who have lost erectile function following radical prostatectomy for prostate cancer. During this study a total of 100 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure (PRP-NR).

Conditions

Prostate Cancer

Erectile Dysfunction Following Radical Prostatectomy

Study ID

NCT07188064

Start date

Jan 30, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with persistent post prostatectomy erectile dysfunction as defined below:

1. Severe ED (IIEF score 5-7) and more than 12 months from prostatectomy OR
2. Moderate ED (IIEF score 8-11) and more than 18 months from prostatectomy
  • Patients must have had good pre-prostatectomy erectile function with a baseline IIEF score of ≥17 on self-reported assessment of historic function.

Exclusion Criteria:

  • Patients aged < 18 years at diagnosis
  • Legally incapable patients
  • Patients >5 years from prostatectomy.
  • Bilateral open inguinal hernia repair
  • Patients with pre-existing significant neurologic disease
  • Diabetes with evidence of peripheral nerve involvement and end organ dysfunction
  • Coronary artery disease with unstable angina
  • Mood disorder (anxiety/depression) with change in medical therapy within last 3 months
  • Pre-existing penile base surgery which would prevent grafting technique including suprapubic liposuction, suspensory ligament release
  • Pre-existing penile prosthesis
  • Current use of androgen deprivation therapy
  • Use of medications for chronic nerve pain (gabapentin, amitriptyline, nortriptyline, pregablin)
  • Previous untreated penile trauma
  • Patients deemed medically unfit for surgery

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Post radical prostatectomy nerve restoration procedure

A somatic to autonomic nerve grafting procedure which will use a nerve graft of ilioinguinal nerve harvested from the inguinal canal to perform a bilateral end to side junction between the dorsal penile nerve and the penile corpora cavernosa

Interventions

Post radical prostatectomy nerve restoration procedure (PRP-NR)

Somatic to autonomic nerve grafting procedure which uses a nerve graft of ilioinguinal nerve harvested from the inguinal canal to perform a bilateral end to side junction between the dorsal penile nerve and the penile corpora cavernosa

Primary outcome measure

  • International Index of Erectile Function-5 (IIEF-5) [ Time Frame: 4 weeks post PRP-NR ]
  • International Index of Erectile Function-5 (IIEF-5) [ Time Frame: 3 months post PRP-NR ]
  • Clinical Evolution of Erectile Function (CEEF) [ Time Frame: 24 months post PRP-NR ]
  • Clinical Evolution of Erectile Function (CEEF) [ Time Frame: 18 months post PRP-NR ]
  • Clinical Evolution of Erectile Function (CEEF) [ Time Frame: 12 months post PRP-NR ]
  • Clinical Evolution of Erectile Function (CEEF) [ Time Frame: 6 months post PRP-NR ]
  • Clinical Evolution of Erectile Function (CEEF) [ Time Frame: 3 months post PRP-NR ]
  • Clinical Evolution of Erectile Function (CEEF) [ Time Frame: 4 weeks post PRP-NR ]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 24 months post PRP-NR ]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 18 months post PRP-NR ]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 12 months post PRP-NR ]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 6 months post PRP-NR ]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 3 months post PRP-NR ]
  • Short Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: 4 weeks post PRP-NR ]
  • International Index of Erectile Function-5 (IIEF-5) [ Time Frame: 24 months post PRP-NR ]
  • International Index of Erectile Function-5 (IIEF-5) [ Time Frame: 18 months post PRP-NR ]
  • International Index of Erectile Function-5 (IIEF-5) [ Time Frame: 12 months post PRP-NR ]
  • International Index of Erectile Function-5 (IIEF-5) [ Time Frame: 6 months post PRP-NR ]

Central Contacts and Locations

Central contacts

Victor McPherson, MD

514-340-8222victor.mcpherson@mcgill.ca

Locations

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Victor McPherson, MD

514-340-8222victor.mcpherson@mcgill.ca

Oleg Loutochin, MD

514-340-8222oloutochin@jgh.mcgill.ca

More Information

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sir Mortimer B. Davis - Jewish General Hospital on 2026-03-10.