Evaluating Return to Continence and Potency Following Rad... | NCT05742334

NCT05742334

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
WFBCCC 85321	Other Identifier	Wake Forest Baptist Comprehensive Cancer Center

Status Module

Name	Class
Samaritan Biologics	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robot Assisted Radical Prostatectomy with MLG-COMPLETE Allograft	Experimental	Implantation of the MLG-COMPLETE allograft during your robot-assisted radical prostatectomy surgery.	Procedure: Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation Device: MLG-COMPLETE Allograft Implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Up to 12 months
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	Up to 12 months
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.	Up to 12 months
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.	Up to 12 months
Average Time for Participants to Return to Potency - Sexual Health Inventory for Men (SHIM) Questionnaire

Eligibility Module

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.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms