Evaluating Return to Continence and Potency Following Radical Prostatectomy
Prostate Cancer
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
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
Experimental
Robot Assisted Radical Prostatectomy with MLG-COMPLETE Allograft
Implantation of the MLG-COMPLETE allograft during your robot-assisted radical prostatectomy surgery.