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NCT Number: NCT06521710

Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy

The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring (NR) Robotically assisted laparoscopic radical prostatectomy (RALP). During this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique, NR-RALP, which incorporates a genitofemoral (GFN) nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure

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Key information

Conditions

Prostate Cancer Erectile Dysfunction Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Jewish General Hospital, Montreal, Quebec, Canada

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About this study

Patients will have baseline evaluation with International Index of Erectile Function-5 (IIEF-5) questionnaire and the Short Form McGill Pain Questionnaire (SF-MPQ)1, which will be re-evaluation at time of their standard of care post-operative visits at 4 weeks, 3-, 6-, 12- and 18-months. Post-operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of:
  • Gleason grade ≥8
  • PSA ≥20
  • >pT2 on preoperative MRI imaging
  • Patients must have preoperative erectile function with a baseline IIEF score of ≥17

Exclusion criteria

  • Patients with previous pelvic surgery
  • Patients with previous pelvic radiotherapy
  • Patient with previous focal therapy for prostate cancer
  • Patients aged < 18 years at diagnosis
  • Legally incapable patients
  • Patients who are unable to complete questionnaires and have no companion to help complete them
  • Patients undergoing a concomitant cancer surgery
  • Patients with pre-existing neurologic disease

Treatment and study plan

Intraoperative Somatic-Autonomic Nerve Grafting

Procedure

A one-sided graft using a genitofemoral (GFN) nerve graft between one obturator nerve and the corpora cavernosa

Primary outcomes

  1. Adverse events measured by the Clavian-Dindo classification

    Time frame: Through study completion, an average of 18 months

    The primary outcome is specifically the safety of the operation 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).

    Grade I Deviation from normal p/o course. No pharmacological or surgical treatment, endoscopic or radiological interventions were required. Acceptable therapeutic drugs such as anti-emetics, antipyretics, analgesics, diuretics,electrolytes, physiotherapy. Wound infections, small abscess requiring incision at bedside.

    Grade II Normal course altered. Pharmacological management other than in Grade I. Blood transfusions and total parenteral nutrition are also included.

    Grade III Complications that require intervention of various degrees. Grade IV Complications threatening life of patients (including Central Nervous System complications), requiring Intensive Treatment Unit support.

    Grade V Death of a patient.

Secondary outcomes

  1. International Index of Erectile Function-5 (IIEF-5)

    Time frame: Screening pre-NR-RALP procedure

    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).

  2. International Index of Erectile Function-5 (IIEF-5)

    Time frame: 4-6 weeks post-NR-RALP procedure

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

    Time frame: 3 months post-NR-RALP procedure

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

    Time frame: 6 months post-NR-RALP procedure

    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).

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

    Time frame: 12 months post-NR-RALP procedure

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

    Time frame: 18 months post-NR-RALP procedure

    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).

  7. Short Form McGill Pain Questionnaire (SF-MPQ)

    Time frame: Screening pre-NR-RALP procedure

    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)

  8. Short Form McGill Pain Questionnaire (SF-MPQ)

    Time frame: 4-6 weeks post-NR-RALP procedure

    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)

  9. Short Form McGill Pain Questionnaire (SF-MPQ)

    Time frame: 3 months post-NR-RALP procedure

    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)

  10. Short Form McGill Pain Questionnaire (SF-MPQ)

    Time frame: 6 months post-NR-RALP procedure

    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)

  11. Short Form McGill Pain Questionnaire (SF-MPQ)

    Time frame: 12 months post-NR-RALP procedure

    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. Short Form McGill Pain Questionnaire (SF-MPQ)

    Time frame: 18 months post-NR-RALP procedure

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Oleg Loutochin

CONTACT

[email protected]

514-340-8222 ext. 21627

Victor McPherson, MD

CONTACT

[email protected]

514-340-8222 ext. 24904

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Official study title

Phase I Clinical Trial: Pilot Study of Intraoperative Somatic-Autonomic Nerve Grafting Technique to Preserve Erectile Function in Patients With High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy

Acronym: NR-RALP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 26, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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