Localized Prostate CarcinomaRAPNCT06940271
Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
A study testing Allografting and Survey Administration in people with Localized Prostate Carcinoma and Stage I Prostate Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8
- What is being tested?
- Allografting and Survey Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2025to 30 Jul 2030
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects with age ≥ 45
- Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy)
- Primary diagnosis of organ confined (i.e. localized) untreated prostate cancer
- Planned elective radical prostatectomy with bilateral nerve sparing technique
- Patient has no erectile dysfunction (SHIM score ≥ 19) at the time of consultation
- Willing to comply with instruction of the investigator
Show all 10Show fewer
- Willing to comply with follow-up surveys
- Ability to provide written consent
- Negative urinary tract infection at the time of consultation
- Interest in penetrative sexual intercourse
Who cannot join
- High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
- Unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
- History of >14 days treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period
- Prior hormonal therapy such as Lupron or oral anti-androgens
- Poor urinary control at baseline requiring the use of pads for leakage
- Previous history of pelvic radiation
Show all 15Show fewer
- Previous history of simple prostatectomy or transurethral prostate surgery
- Patients with obesity defined as body mass index (BMI) > 40 kg/m^2
- History of open pelvic surgery ≤ 5 prior to registration (except for hernia repair)
- Scheduled to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
- Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
- Has any condition(s) which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
- In the opinion of the principal investigator (PI), has a history of drug or alcohol abuse ≤ 12 months prior to registration
- Allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin)
- Received administration of an investigational drug within 30 days prior to registration, and/or has planned administration of another investigational product or procedure during participation in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Ram Pathak, MD
About this study
Official title: RAP: Prospective Pragmatic Multi-Site Trial Evaluating the Feasibility and Effect of Wrapping the Cavernous Nerves With a Novel Multi-Layer Perinatal Tissue Allograft During Prostatectomy
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.
- Conditions
- Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Being tested
- Allografting, Survey Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllograftingProcedure or surgery
Also called allograft
Undergo placement of MLG-Complete allograft
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Allografting; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 weeks post-RARP
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start14 Aug 2025
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ram A. Pathak, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940271
- Sponsor's protocol ID
- MC240501
- Other IDs
- NCI-2025-02552, 23-013215, MC240501
- Acronym
- RAP
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAP: Prospective Pragmatic Multi-Site Trial Evaluating the Feasibility and Effect of Wrapping the Cavernous Nerves With a Novel Multi-Layer Perinatal Tissue Allograft During Prostatectomy
- ClinicalTrials.gov ID
- NCT06940271
- Acronym / sponsor ID
- RAP / MC240501
- Conditions
- Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 23 Apr 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (MLG-Complete allograft) | Experimental | Procedure: Allografting, Other: Survey AdministrationPatients undergo placement of MLG-Complete allograft to nerve bundles over 5 minutes during standard of care nerve-sparing RARP. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male subjects with age ≥ 45
- Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy)
- Primary diagnosis of organ confined (i.e. localized) untreated prostate cancer
- Planned elective radical prostatectomy with bilateral nerve sparing technique
- Patient has no erectile dysfunction (SHIM score ≥ 19) at the time of consultation
Key exclusion criteria (15 listed)
- High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
- Unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
- History of >14 days treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period
- Prior hormonal therapy such as Lupron or oral anti-androgens
- Poor urinary control at baseline requiring the use of pads for leakage
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 |
|---|---|---|
| AllograftingAlso: allograftUndergo placement of MLG-Complete allograft | Procedure or surgery | Supportive care (MLG-Complete allograft) |
| Survey AdministrationAncillary studies | Other | Supportive care (MLG-Complete allograft) |
Primary outcome
Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)
Time frame: Baseline [time of robot-assisted radical prostatectomy (RARP)]
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.
Incidence of serious adverse events related to graft placement
Time frame: Up to 6 weeks post-RARP
Will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
9 secondary outcomes
Average time for return of potency
Time frame: At 6-weeks and 3-, 6-, and 12-months post RARP
Average time for return to continence
Time frame: At 6-weeks and 3-, 6-, and 12-months post-RARP
Change in SHIM
Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Change in AUASS
Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Change in Quality of Life - AUASS survey
Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Change in ICIQ-UI
Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Change in QoL - EPIC-26
Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Cost/value analysis
Time frame: Up to 12 months post-RARP
Unplanned interactions with the healthcare team
Time frame: Up to 12 weeks
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 11 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Localized Prostate Carcinoma
Not yet recruitingPhase 2
Deutenzalutamide and Hormone Therapy Before and After Surgery With Docetaxel Before Surgery for High-Risk Localized or Locally Advanced Prostate Cancer
Prostate Cancer (Adenocarcinoma)
RecruitingPhase 2
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
Active, not recruiting
Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device
Prostate, Cancer
Active, not recruitingPhase 3
Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer
Stage II Prostate Adenocarcinoma AJCC v7
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.
Ram A. Pathak, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allografting and Survey Administration in people with Localized Prostate Carcinoma and Stage I Prostate Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
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 10 inclusion and 15 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to place MLG-Complete allograft without lengthening operative time (Feasibility) (time frame: Baseline [time of robot-assisted radical prostatectomy (RARP)]). The study lists 2 primary outcomes in all. 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 11 Sep 2026.