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Prostate CancerNCT05742334

Evaluating Return to Continence and Potency Following Radical Prostatectomy

A study testing Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation and MLG-COMPLETE Allograft Implantation in people with Prostate Cancer, run by Wake Forest University Health Sciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this research is to determine if using human placental membrane (also called an allograft) helps to improve recovery time for erectile function and bladder control after having robot-assisted radical prostatectomy (RARP) surgery. Read more about this study

Who is it for?
Ages 40 to 70 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation and MLG-COMPLETE Allograft Implantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2023to May 2025
Phase
Interventional
Are there results?
None posted in the registry

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 40 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male subjects age 40 to 70.
  • Primary diagnosis of untreated clinically localized prostate cancer as defined by histopathological diagnosis by prostate biopsy and cross sectional imaging, as indicated based on guidelines.
  • Planned elective robot-assisted radical prostatectomy with bilateral nerve sparing technique for clinically localized prostate cancer.
  • Urine bacterial culture should be negative for infection within 30 days of surgery.
  • Patient has no erectile dysfunction (Sexual Health Inventory for Men [SHIM] Score >17) prior to the date of surgery.
  • Patient is willing to follow study procedures and complete follow-up surveys.
  • Patient has the ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Who cannot join

  • Patients with high-risk prostate cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles.
  • Patient is unable to document penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications.
  • Patients who received treatment with immuno-suppressants (including systemic corticosteroids) within two weeks prior to surgery or those who anticipate requiring immunosuppressive treatment during the study.
  • Patients who received cytotoxic chemotherapy within one month prior to initial screening, or who receive this treatment during the screening period, or who are anticipated to require treatment during the course of the study.
  • Patients that have had prior hormonal therapy such as Lupron or oral anti-androgens.
  • Patients with poor urinary control at baseline requiring the use of pads for leakage.
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  • Previous history of pelvic radiation.
  • Previous history of simple prostatectomy or transurethral prostate surgery.
  • Patients with obesity defined as body mass index > 40 kg/m2.
  • History of open pelvic surgery except for hernia repair.
  • Patients with diabetes.
  • Patients scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
  • Neurologic or psychiatric disorders that may confound postsurgical assessments determined at the discretion of the investigator.
  • Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study.

About this study

Official title: RAP: Prospective Pilot Trial Evaluating Return to Continence and Potency Following Radical Prostatectomy Using Novel Multi-Layer Perinatal Tissue Allograft

The purpose of this research is to determine if using human placental membrane (also called an allograft) helps to improve recovery time for erectile function and bladder control after having robot-assisted radical prostatectomy (RARP) surgery.

Read the detailed description

Primary Objective(s):

  • To evaluate the safety and feasibility of MLG-Complete™ allograft placement in patients who undergo robot-assisted radical prostatectomy (RARP) with bilateral nerve sparing.
  • To determine the effectiveness of using MLG-Complete™ allograft to optimize return to erectile function (potency) in patients who have had robot-assisted radical prostatectomy (RARP) with bilateral nerve sparing by utilizing the Sexual Health Inventory for Men (SHIM) score.
  • To determine the effectiveness of using MLG-Complete™ allograft to optimize return to continence in patients who have had robot-assisted radical prostatectomy (RARP) with bilateral nerve sparing by utilizing the American Urological Association (AUA) symptom score, assessing daily pad use from direct patient report, and by utilizing the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI Short Form).

OUTLINE: Patients undergo RARP with placement of the MLG-Complete allograft on study.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.

Conditions
Prostate Cancer
Being tested
Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation, MLG-COMPLETE Allograft Implantation
Keywords
Bladder continence after prostatectomy, Erectile function after prostatectomy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft ImplantationProcedure or surgery

    The intervention will be administered on an inpatient basis. Participants receiving MLG-Complete™ will have it placed around the neurovascular bundle. Placement of the graft should not take more than 5 minutes, therefore, there should be minimal impact to overall surgical time.

  • MLG-COMPLETE Allograft ImplantationDevice

    The MLG-Complete™ allograft will be placed on each neurovascular bundle (NVB) bilaterally as shown on the above picture after excision of the prostate prior to completing the urethrovesical anastomosis.

Study groups in NCT05742334
Study groupRoleWhat they receive
Robot Assisted Radical Prostatectomy with MLG-COMPLETE AllograftExperimentalImplantation of the MLG-COMPLETE allograft during your robot-assisted radical prostatectomy surgery.
Receives: Procedure: Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation; Device: MLG-COMPLETE Allograft Implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse Events Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Safety will be assessed by describing the frequency and nature of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 throughout the study

    Measured: Up to 12 months

  2. Number of Adverse Events Using the Clavien-Dindo Classification System

    Adverse effects per the Clavien-Dindo Classification system will be assessed descriptively post-graft placement The Clavien-Dindo system is widely used throughout surgery for grading adverse events (i.e. complications) which occur as a result of surgical procedures. It consists of 7 grades.

    Grade I - Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions; Grade II - Requiring pharmacological treatment with drugs other than such allowed for grade I complications Grade III - Requiring surgical, endoscopic or radiological intervention

    • IIIa - Intervention not under general anesthesia
    • IIIb - Intervention under general anesthesia; Grade IV - Life-threatening complication (including central nervous system complications) requiring intensive care/intensive care unit-management
    • IVa - single organ dysfunction (including dialysis)
    • IVb - Multi-organ dysfunction and Grade V - Death

    Measured: Up to 12 months

  3. Number of Participants Screened for Enrollment

    Feasibility will be assessed by determining the number of patients screened in order to enroll the anticipated number of participants to study intervention.

    Measured: Up to 12 months

  4. Number of Participants to Complete Intervention

    Rates of completion will be determined at each visit based on the anticipated number of participants to study intervention that complete each visit.

    Measured: Up to 12 months

  5. Average Time for Participants to Return to Potency - Sexual Health Inventory for Men (SHIM) Questionnaire

    Return to potency will be defined as the time to attain the ability to achieve an erection sufficient for intercourse >50% of the time or at least 50% rigidity compared to baseline status post robot-assisted radical prostatectomy using the Sexual Health Inventory for Men (SHIM) questionnaire. This questionnaire is used to diagnose erectile dysfunction (ED) and severity as moderate score ranging 8-11, mild to moderate 12-16, 17-21 mild, and 22-25 no ED

    Measured: Up to 12 months

  6. Average Time to Return to Bladder Control/Urinary Continence - ICIQ-UI Short Form

    effectiveness will be measured by the average time for return to continence as defined as the time from radical prostatectomy to until the use of < 1 incontinence pad and by the and by the ICIQ-UI Short Form. This tool is a four-item questionnaire to objectively evaluate urinary incontinence (UI) and its associated impact on quality of life. Scores range from 0-21 with a higher score indicating greater severity.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study startJul 2023 (estimated)
  3. Primary completionMay 2024 (estimated)
  4. Study completionMay 2025 (estimated)

Why it stopped: The sponsor decided to not move forward with this study

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05742334
Sponsor's protocol ID
IRB00093386
Other IDs
WFBCCC 85321
Status last verified
May 2023
First submitted
2 Feb 2023
Last updated
2 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation and MLG-COMPLETE Allograft Implantation in people with Prostate Cancer, run by Wake Forest University Health Sciences.

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 7 inclusion and 14 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: withdrawn, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (time frame: Up to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05742334.

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 2 Jun 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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