Back to Search Results- Recruiting
- Treatment
- Interventional
- Randomized
- Drug & Procedure
- PHASE2
- Johns Hopkins University
- 40 - 65 Years
Study Purpose
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 diabetic foot ulcers, acute and chronic surgical wounds, various fistulas and even as a nerve wrap on the common peroneal nerve. Surgical technique for nerve-sparing prostatectomy has evolved continuously since first described by Walsh in 1982 and is now commonly performed with robotic assistance. The investigators intend to study whether placement of LPT over the spared neurovascular bundle during nerve-sparing robotic prostatectomy will improve return to potency and/or continence after robotic radical prostatectomy for prostate cancer. Patients with a preoperative Sexual Health Inventory for Men (SHIM) score \> 19 (moderate or high pre-op sexual function) planning to undergo robotic-assisted laparoscopic prostatectomy will be randomized to receive direct placement of LPT over the preserved neurovascular bundles vs standard of care. Patients will independently report erectile function and continence at 1 months, 3 months, 6 months and 1 year after surgery. Primary outcomes would include mean time to achieve potency, percentage of group achieving potency at each time point, and mean change in SHIM score. Secondary outcomes would include mean time to achieve continence. The investigators will also report any adverse events.
Intervention
Drug : Stravix lyopreserved placental tissue (LPT)
Procedure : Radical prostatectomy
Eligibility Requirements
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)
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 Salin
Recruiting status
Recruiting
Estimated enrollment
60
Study start date
Apr 01, 2022
Study end date
Dec 01, 2025
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Drug & Procedure
Study phase
PHASE2
Allocation
Randomized
Sponsor:
Johns Hopkins University
Collaborator:
N/A
Investigator:
Arthur Burnett, MD
N/A
Publications
Websites
N/A
NCT05366842
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