Prostate CancerNR-RALPNCT06521710
Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy
A study testing Intraoperative Somatic-Autonomic Nerve Grafting in people with Prostate Cancer and Erectile Dysfunction, run by Sir Mortimer B. Davis - Jewish General Hospital at 2 sites in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction
- What is being tested?
- Intraoperative Somatic-Autonomic Nerve Grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Jewish General Hospital, CIUSSS Centre-Ouest de l'île de Montréal
Montreal, Quebec, H3T 1E2
Victor McPherson, MD, 514-340-8222 ext. 21627, victor.mcpherson@mcgill.ca
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Victor McPherson, MD, 514-340-8222 ext. 24904, victor.mcpherson@gmail.com
Oleg Loutochin, 514-340-8222 ext. 21627, oloutochin@jgh.mcgill.ca
About this study
Official 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
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
Read the detailed description
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.
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Being tested
- Intraoperative Somatic-Autonomic Nerve Grafting
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Somatic-Autonomic Nerve GraftingProcedure or surgery
A one-sided graft using a genitofemoral (GFN) nerve graft between one obturator nerve and the corpora cavernosa
| Study group | Role | What they receive |
|---|---|---|
| NR-RALP | Experimental | Nerve Grafting Technique in patients with High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy Receives: Procedure: Intraoperative Somatic-Autonomic Nerve Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events measured by the Clavian-Dindo classification
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.
Measured: Through study completion, an average of 18 months
Secondary outcomes (12)
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).
Measured: Screening pre-NR-RALP procedure
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).
Measured: 4-6 weeks post-NR-RALP procedure
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).
Measured: 3 months post-NR-RALP procedure
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).
Measured: 6 months post-NR-RALP procedure
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).
Measured: 12 months post-NR-RALP procedure
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).
Measured: 18 months post-NR-RALP procedure
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)
Measured: Screening pre-NR-RALP procedure
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)
Measured: 4-6 weeks post-NR-RALP procedure
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)
Measured: 3 months post-NR-RALP procedure
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)
Measured: 6 months post-NR-RALP procedure
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)
Measured: 12 months post-NR-RALP procedure
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)
Measured: 18 months post-NR-RALP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor McPherson, Sir Mortimer B. Davis - Jewish General Hospital
- Investigators
- Victor McPherson, MD, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521710
- Sponsor's protocol ID
- 2024-4129
- Acronym
- NR-RALP
- Status last verified
- Sep 2024
- First submitted
- 21 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06521710
- Acronym / sponsor ID
- NR-RALP / 2024-4129
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NR-RALP | Experimental | Procedure: Intraoperative Somatic-Autonomic Nerve GraftingNerve Grafting Technique in patients with High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of:
- Patients must have preoperative erectile function with a baseline IIEF score of ≥17
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Somatic-Autonomic Nerve GraftingA one-sided graft using a genitofemoral (GFN) nerve graft between one obturator nerve and the corpora cavernosa | Procedure or surgery | NR-RALP |
Primary outcome
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.
12 secondary outcomes
International Index of Erectile Function-5 (IIEF-5)
Time frame: Screening pre-NR-RALP procedure
International Index of Erectile Function-5 (IIEF-5)
Time frame: 4-6 weeks post-NR-RALP procedure
International Index of Erectile Function-5 (IIEF-5)
Time frame: 3 months post-NR-RALP procedure
International Index of Erectile Function-5 (IIEF-5)
Time frame: 6 months post-NR-RALP procedure
International Index of Erectile Function-5 (IIEF-5)
Time frame: 12 months post-NR-RALP procedure
International Index of Erectile Function-5 (IIEF-5)
Time frame: 18 months post-NR-RALP procedure
Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: Screening pre-NR-RALP procedure
Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 4-6 weeks post-NR-RALP procedure
Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 3 months post-NR-RALP procedure
Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 6 months post-NR-RALP procedure
Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 12 months post-NR-RALP procedure
Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 18 months post-NR-RALP procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Victor McPherson, MD principal investigator
Jewish General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Somatic-Autonomic Nerve Grafting in people with Prostate Cancer and Erectile Dysfunction, run by Sir Mortimer B. Davis - Jewish General Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor McPherson, MD (514-340-8222 ext. 24904, victor.mcpherson@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events measured by the Clavian-Dindo classification (time frame: Through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.