NCT07188064

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
32mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

September 15, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

September 15, 2025

Last Update Submit

March 7, 2026

Conditions

Prostate CancerErectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (18)

  • International Index of Erectile Function-5 (IIEF-5)

    The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).

    4 weeks post PRP-NR

  • International Index of Erectile Function-5 (IIEF-5)

    The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).

    3 months post PRP-NR

  • Clinical Evolution of Erectile Function (CEEF)

    A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).

    24 months post PRP-NR

  • Clinical Evolution of Erectile Function (CEEF)

    A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).

    18 months post PRP-NR

  • Clinical Evolution of Erectile Function (CEEF)

    A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).

    12 months post PRP-NR

  • Clinical Evolution of Erectile Function (CEEF)

    A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).

    6 months post PRP-NR

  • Clinical Evolution of Erectile Function (CEEF)

    A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).

    3 months post PRP-NR

  • Clinical Evolution of Erectile Function (CEEF)

    A one question visual questionnaire evaluating the erectile function, from 0 (no erection - Worst Possible Outcome) to 10 (sexual intercourse - Best Possible Outcome).

    4 weeks post PRP-NR

  • Short Form McGill Pain Questionnaire (SF-MPQ)

    The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)

    24 months post PRP-NR

  • Short Form McGill Pain Questionnaire (SF-MPQ)

    The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)

    18 months post PRP-NR

  • Short Form McGill Pain Questionnaire (SF-MPQ)

    The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)

    12 months post PRP-NR

  • Short Form McGill Pain Questionnaire (SF-MPQ)

    The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)

    6 months post PRP-NR

  • Short Form McGill Pain Questionnaire (SF-MPQ)

    The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)

    3 months post PRP-NR

  • Short Form McGill Pain Questionnaire (SF-MPQ)

    The SF-MPQ was designed to measure post-surgical pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The sum of the scores gives a range of outcomes; a score of 0 (no pain - Best Possible Outcome) to a score of 45 (Most severe pain - Worst Possible Outcome)

    4 weeks post PRP-NR

  • International Index of Erectile Function-5 (IIEF-5)

    The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).

    24 months post PRP-NR

  • International Index of Erectile Function-5 (IIEF-5)

    The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).

    18 months post PRP-NR

  • International Index of Erectile Function-5 (IIEF-5)

    The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).

    12 months post PRP-NR

  • International Index of Erectile Function-5 (IIEF-5)

    The IIEF-5 is used to determine the prevalence of erectile dysfunction (ED) in a non-selected population using the abridged 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool. Each answer has a score from 1 (very low) to 5 (very high). The sum of all the answers gives a final result of 1-7 (Severe ED - Worst Outcome), 8-11 (Moderate ED), 12-16 (Mild-moderate ED), 17-21 (Mild ED) and 22-25 (No ED - Best Outcome).

    6 months post PRP-NR

Secondary Outcomes (1)

  • The secondary outcome is specifically the safety of the operation. This will be measured by adverse events as defined by the Clavian-Dindo classification.The measurement varies from Grade I (Best possible outcome) to Grade V (Worst possible outcome).

    Through study completion, an average of 2 years

Study Arms (1)

Post radical prostatectomy nerve restoration procedure

EXPERIMENTAL

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

Procedure: Post radical prostatectomy nerve restoration procedure (PRP-NR)

Interventions

Post radical prostatectomy nerve restoration procedure (PRP-NR)PROCEDURE

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

Post radical prostatectomy nerve restoration procedure

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with persistent post prostatectomy erectile dysfunction as defined below:
  • Severe ED (IIEF score 5-7) and more than 12 months from prostatectomy OR
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Victor McPherson, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, FRCSC, Assistant Professor Division of Urology

Study Record Dates

First Submitted

September 15, 2025

First Posted

September 23, 2025

Study Start

January 30, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

CA(1)