Status:
TERMINATED
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
Lead Sponsor:
Johns Hopkins University
Conditions:
Prostate Cancer
Eligibility:
MALE
40-65 years
Phase:
PHASE2
Brief Summary
Surgical implantation of Lyopreserved Placental Tissue (LPT) is FDA approved and has been used extensively in wound care. The use is expanding and more recently, LPT has been used in the management of...
Eligibility Criteria
Inclusion
- 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)
- Scheduled to undergo curative radical prostatectomy applying bilateral nerve-sparing procedure
- 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)
- Willingness to attempt intercourse at least 5 times per month following surgery.
- Has a sexual partner of at least 6 months with current sexual activity (within the past 4 weeks)
Exclusion
- Known penile deformity or a history of Peyronie's disease
- Pre or postoperative androgen therapy
- Pre or postoperative radiation therapy
- History of high or low blood pressure that is not controlled
- Taking nitrates medications
- History of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction
- History of drug or alcohol abuse
- Current smoker has a 20 pack/year history of cigarette smoking
- History of acute or chronic depression
- History of liver problems or kidney problems
- History of retinitis pigmentosa or severe vision loss, including a condition called NAION
- History of spinal trauma or surgery to the brain or spinal cord
- Other contraindications to the use of phosphodiesterase inhibitor (PDE) 5 inhibitors
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05366842
Start Date
April 1 2022
End Date
April 25 2025
Last Update
June 5 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287