Clinical trial NCT05742334: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Bladder continence after prostatectomy
Erectile function after prostatectomy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Samaritan Biologics
First posted: 2023-02-24
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Adverse Events Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: Up to 12 months
measure: Number of Adverse Events Using the Clavien-Dindo Classification System
timeFrame: Up to 12 months
measure: Number of Participants Screened for Enrollment
timeFrame: Up to 12 months
measure: Number of Participants to Complete Intervention
timeFrame: Up to 12 months
measure: Average Time for Participants to Return to Potency - Sexual Health Inventory for Men (SHIM) Questionnaire
timeFrame: Up to 12 months
measure: Average Time to Return to Bladder Control/Urinary Continence - ICIQ-UI Short Form
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Ashok K Hemal, MD
role: PRINCIPAL_INVESTIGATOR
References: