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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-02552 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23-013215 | Other Identifier | Mayo Clinic Institutional Review Board | |
| MC240501 | Other Identifier | Mayo Clinic |
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This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after nerve-sparing robot-assisted radical prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being. The goal of nerve-sparing radical prostatectomy is to preserve erectile and urinary function, but damage to the surrounding nerves and blood vessels can still occur causing the patient to experience the complications. An allograft is the transplant of an organ, tissue, or cells from one individual to another individual of the same species who is not an identical twin. The MLG-Complete allograft is made up of perinatal tissue and is placed on the nerve bundles during a nerve-sparing RARP. It is meant to serve as a barrier and provide coverage to the nerve bundles from the surrounding environment, which may improve post-nerve-sparing RARP complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (MLG-Complete allograft) | Experimental | Patients undergo placement of MLG-Complete allograft to nerve bundles over 5 minutes during standard of care nerve-sparing RARP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allografting | Procedure | Undergo placement of MLG-Complete allograft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability to place MLG-Complete allograft without lengthening operative time (Feasibility) | Feasibility is defined as the overall technical ability to place the MLG-Complete allograft in included patients without significantly lengthening operative time. This will be defined by a yes/no evaluation by the surgeon. | Baseline [time of robot-assisted radical prostatectomy (RARP)] |
| Incidence of serious adverse events related to graft placement | Will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Up to 6 weeks post-RARP |
| Measure | Description | Time Frame |
|---|---|---|
| Average time for return of potency | Will be defined as the ability to achieve an erection sufficient for intercourse for at least 50% of the time or at least 50% rigidity post RARP. Will be assessed using the Sexual Health Inventory for Men (SHIM) and patient-reported history. The SHIM is a five-question instrument with a score of 1-25 points. A higher score generally indicates greater ability to achieve an erection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ram A. Pathak, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Survey Administration | Other | Ancillary studies |
|
| At 6-weeks and 3-, 6-, and 12-months post RARP |
| Average time for return to continence | Return to continence will be defined as use of =< 1 pad post-RARP. | At 6-weeks and 3-, 6-, and 12-months post-RARP |
| Change in SHIM | Sexual Health Inventory for Men (SHIM) scores will be collected at study enrollment, 6 weeks, 3 months, 6 month, and 12 months. The SHIM consists of five questions that explore aspects of erectile function. Scores range from 1-25. A score of 20 or higher indicates a normal degree of erectile functioning. Lower scores (10 or less) indicate moderate to severe erectile dysfunction (ED). | At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP |
| Change in AUASS | The American Urological Association Symptom Score (AUASS) consists of 5 questions related to urological symptoms over the past month. Questions are answered on a scale of 0-5 where 0=not at all and 5=almost always and one question related to nighttime urination (times per night average over the past month). A lower overall score indicates lesser urological symptoms. | At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP |
| Change in Quality of Life - AUASS survey | Assessed with a single survey question answered on a scale of 0-6 where 0=delighted and 6=terrible. | At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP |
| Change in ICIQ-UI | The International Consultation on Incontinence Questionnaire: Short Form for Urinary Incontinence (ICIQ-UI) is a 4-item questionnaire related to urine incontinence over the past 4 weeks. A higher summary scores indicates worse incontinence. | At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP |
| Change in QoL - EPIC-26 | The Expanded Prostate Cancer Index Composite (EPIC-26) is a 26-item questionnaire related to Quality of Life issues in patients with Prostate Cancer. The survey consists of 26 items under 5 domains: urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. | At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP |
| Cost/value analysis | Costs of prescription [Oral Phosphodiesterase 5 Inhibitor (PDE-5i), Intracavernosal injection, Alprostadil urethral suppository) or future surgery (inflatable penile prosthesis] will be recorded. | Up to 12 months post-RARP |
| Unplanned interactions with the healthcare team | The proportion of patients with an unplanned phone call, portal message, or unscheduled clinic, emergency room, or urgent care visit will be computed and presented. The total number of unplanned phone calls, portal messages, or health care visits will be summarized. | Up to 12 weeks |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D014184 | Transplantation, Homologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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