Evaluating Return to Continence and Potency Following Radical Prostatectomy

NCT ID: NCT05742334

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2025-05-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robot Assisted Radical Prostatectomy with MLG-COMPLETE Allograft

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

Group Type: EXPERIMENTAL

Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation

Intervention Type: PROCEDURE

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 Implantation

Intervention Type: DEVICE

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.

Interventions

Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation

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: PROCEDURE

MLG-COMPLETE Allograft Implantation

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Samaritan Biologics

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashok K Hemal, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Comprehensive Cancer Center

Other Identifiers

WFBCCC 85321

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00093386

Identifier Type: -

Identifier Source: org_study_id