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Evaluating Return to Continence and Potency Following Radical Prostatectomy

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation
MLG-COMPLETE Allograft Implantation
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Bladder continence after prostatectomy, Erectile function after prostatectomy

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Robot Assisted Radical Prostatectomy with MLG-COMPLETE Allograft

    Arm Description

    Implantation of the MLG-COMPLETE allograft during your robot-assisted radical prostatectomy surgery.

    Outcomes

    Primary Outcome Measures

    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
    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
    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.
    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.
    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2023
    Last Updated
    May 30, 2023
    Sponsor
    Wake Forest University Health Sciences
    Collaborators
    Samaritan Biologics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05742334
    Brief Title
    Evaluating Return to Continence and Potency Following Radical Prostatectomy
    Official Title
    RAP: Prospective Pilot Trial Evaluating Return to Continence and Potency Following Radical Prostatectomy Using Novel Multi-Layer Perinatal Tissue Allograft
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The sponsor decided to not move forward with this study
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences
    Collaborators
    Samaritan Biologics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    Bladder continence after prostatectomy, Erectile function after prostatectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Robot Assisted Radical Prostatectomy with MLG-COMPLETE Allograft
    Arm Type
    Experimental
    Arm Description
    Implantation of the MLG-COMPLETE allograft during your robot-assisted radical prostatectomy surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    MLG-COMPLETE Allograft Implantation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of Adverse Events Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
    Description
    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
    Time Frame
    Up to 12 months
    Title
    Number of Adverse Events Using the Clavien-Dindo Classification System
    Description
    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
    Time Frame
    Up to 12 months
    Title
    Number of Participants Screened for Enrollment
    Description
    Feasibility will be assessed by determining the number of patients screened in order to enroll the anticipated number of participants to study intervention.
    Time Frame
    Up to 12 months
    Title
    Number of Participants to Complete Intervention
    Description
    Rates of completion will be determined at each visit based on the anticipated number of participants to study intervention that complete each visit.
    Time Frame
    Up to 12 months
    Title
    Average Time for Participants to Return to Potency - Sexual Health Inventory for Men (SHIM) Questionnaire
    Description
    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
    Time Frame
    Up to 12 months
    Title
    Average Time to Return to Bladder Control/Urinary Continence - ICIQ-UI Short Form
    Description
    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.
    Time Frame
    Up to 12 months

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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). Exclusion Criteria: 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. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ashok K Hemal, MD
    Organizational Affiliation
    Wake Forest Baptist Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluating Return to Continence and Potency Following Radical Prostatectomy

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