Evaluating the use of umbilical cord allograft during prostate surgery

Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

This study is testing if using a special umbilical cord treatment during prostate surgery can help men recover better in terms of sexual and urinary function.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 30 Years to 70 Years
• Sex: Male
• Sponsor: Hackensack Meridian Health (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Hackensack, New Jersey)
• Trial ID: NCT04263025 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether the use of CLARIX® CORD 1K, a cryopreserved umbilical cord allograft, during robotic-assisted radical prostatectomy (RARP) can enhance recovery of erectile and urinary function in men with prostate cancer. One hundred male patients scheduled for bilateral, nerve-sparing RARP will be randomly assigned to receive either the allograft or standard care without it. Participants will undergo routine evaluations and will be monitored post-surgery for their sexual and urinary function recovery. The study aims to provide insights into the effectiveness of this innovative approach in improving postoperative outcomes.

Who should consider this trial

Good fit: Ideal candidates are males aged 30 to 70 with organ-confined prostate cancer scheduled for bilateral, nerve-sparing RARP.

Not a fit: Patients with a history of pelvic radiation, previous prostate surgeries, or those with certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly accelerate the recovery of erectile and urinary function in patients undergoing prostate surgery.

How similar studies have performed: While the use of umbilical cord allografts in surgical procedures is an emerging area, similar studies have shown promising results in enhancing recovery in other surgical contexts.

Eligibility criteria

Inclusion Criteria:

1. Male aged between 30 and 70 years old
2. Primary diagnosis of organ confined prostate cancer
3. Scheduled to undergo bilateral, nerve-sparing RARP
4. Patient has ICIQ-SF score \<6
5. Patient has no erectile dysfunction (defined as IIEF-6 score ≥ 26)
6. Patient is willing to return for all visits as defined in the protocol
7. Patient is willing to follow the instruction of the Investigator
8. Patient has provided written informed consent

Exclusion Criteria:

1. Previous history of pelvic radiation
2. Previous history of simple prostatectomy or transurethral prostate surgery
3. Previous history of systemic therapy for prostate cancer
4. Patient has neurogenic bladder
5. Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
6. History of open pelvic surgery within 5 years except for hernia repair
7. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
8. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments
9. 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
10. Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B

Where this trial is running

Hackensack, New Jersey

• Hackensack University Medical Center — Hackensack, New Jersey, United States (RECRUITING)

Study contacts

• Principal investigator: Michael Stifelman, MD — Chair of Urology Department
• Study coordinator: Sharon Seidman, RN

Conditions: Prostate Cancer, Prostate cancer, Bilateral, nerve-sparing prostatectomy, Prostatectomy