Using placental tissue to improve erectile recovery after prostate surgery

Patient-Reported Erectile Recovery and Quality of Life Outcomes With Lyopreserved Placental Tissue Applied Directly Over Neurovascular Bundle During Nerve-Sparing Radical Prostatectomy Versus Standard of Care

This study is testing if using preserved placental tissue during prostate surgery can help men recover their ability to have erections and control urination better than regular care.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 40 Years to 65 Years
• Sex: Male
• Sponsor: Johns Hopkins University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05366842 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of applying lyopreserved placental tissue (LPT) over the neurovascular bundle during nerve-sparing robotic prostatectomy for prostate cancer. The study aims to determine if this intervention can enhance recovery of erectile function and urinary continence compared to standard care. Eligible participants are men aged 40 to 65 with localized prostate cancer and intact pre-surgical erectile function, who will be randomized to receive either the LPT treatment or standard care. The trial will measure outcomes using the Sexual Health Inventory for Men (SHIM) score post-surgery.

Who should consider this trial

Good fit: Ideal candidates are men aged 40 to 65 with localized prostate cancer and good preoperative erectile function.

Not a fit: Patients with a history of penile deformity, androgen therapy, or radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve erectile function recovery and quality of life for men undergoing prostate cancer surgery.

How similar studies have performed: Other studies using placental tissue in surgical applications have shown promise, but this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

1. Male sex 40 to 65 years of age with localized prostate cancer (clinical stage less than or equal to T2a, Gleason grade less than or equal to 3+4=7 (Gleason 8 or 4+3=7 will be excluded), Prostate-Specific Antigen (PSA) less than or equal to 10 ng/mL)
2. Scheduled to undergo curative radical prostatectomy applying bilateral nerve-sparing procedure
3. Intact pre-surgical erectile function (International Index of Erectile Function \[IIEF\]-5 / Sexual Health Inventory for Men (SHIM) score greater than or equal to 18)
4. Willingness to attempt intercourse at least 5 times per month following surgery.
5. Has a sexual partner of at least 6 months with current sexual activity (within the past 4 weeks)

Exclusion Criteria:

1. Known penile deformity or a history of Peyronie's disease
2. Pre or postoperative androgen therapy
3. Pre or postoperative radiation therapy
4. History of high or low blood pressure that is not controlled
5. Taking nitrates medications
6. History of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction
7. History of drug or alcohol abuse
8. Current smoker has a 20 pack/year history of cigarette smoking
9. History of acute or chronic depression
10. History of liver problems or kidney problems
11. History of retinitis pigmentosa or severe vision loss, including a condition called NAION
12. History of spinal trauma or surgery to the brain or spinal cord
13. Other contraindications to the use of phosphodiesterase inhibitor (PDE) 5 inhibitors
14. History of known sensitivities to any of the following reagents used for processing, disinfection, and storage, which may remain on the product:

    * Lyopreservation Solution: 18.9% w/v Trehalose in Dulbecco's Phosphate Buffered Saline
    * Disinfection Solution: 0.5% v/v Gentamicin Sulfate, 0.1% v/v Vancomycin reconstituted in Water for Injection (WFI), 1% v/v Amphotericin B, 98.4% Dulbecco's Modified Eagle's Medium (DMEM)
    * Processing Solution: DMEM, Dulbecco's Phosphate Buffered Saline (dPBS), 11% Anticoagulant Citrate Dextrose Solution in Saline, Formula A (ACD-A), 1.7% w/v Trehalose in Dulbecco's Phosphate Buffered Saline

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Arthur Burnett, MD — Johns Hopkins University
• Study coordinator: Shantel Sosa

Conditions Prostate Cancer; erectile dysfunction; radical prostatectomy