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

NCT05366842 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: IRB00168423
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Prostate Cancer

Keywords

erectile dysfunction; radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• Change in Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Score

  The primary outcome variable is the patient's score on the IIEF questionnaire (erectile function domain) at 1,3, 6, 9, 12, and 18 months post-surgery. A comparison of changes in the initial IIEF score will be evaluated to determine treatment efficacy. The IIEF contains 15 questions. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Overall scores will be categorized as follows: * 1-10: Severe Erectile Dysfunction * 11-16: Moderate dysfunction. * 17-21: Mild to moderate dysfunction * 22-25: Mild dysfunction * 26-30: No dysfunction

  1, 3, 6, 9, 12 and 18 months post-surgery

Secondary Outcomes (1)

• Change in Erectile Function and Overall Quality of Life as Assessed by the Expanded Prostate Cancer Index Composite (EPIC) Score From Questionnaires

  1, 3, 6, 9, 12 and 18 months post-surgery

Study Arms (2)

Stravix

EXPERIMENTAL

Direct placement of LPT over the spared neurovascular bundles during bilateral nerve sparing radical prostatectomy for prostate cancer.

Drug: Stravix lyopreserved placental tissue (LPT)

Standard of Care

SHAM COMPARATOR

Standard care (no placement of tissue) bilateral nerve sparing radical prostatectomy for prostate cancer.

Procedure: Radical prostatectomy

Interventions

Radical prostatectomy PROCEDURE

Standard care (no placement of tissue)

Standard of Care

Stravix lyopreserved placental tissue (LPT) DRUG

Participants will undergo surgical implantation of Stravix lyopreserved placental tissue (LPT) during a standard of care radical prostatectomy.

Stravix

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

• Patel VR, Samavedi S, Bates AS, Kumar A, Coelho R, Rocco B, Palmer K. Dehydrated Human Amnion/Chorion Membrane Allograft Nerve Wrap Around the Prostatic Neurovascular Bundle Accelerates Early Return to Continence and Potency Following Robot-assisted Radical Prostatectomy: Propensity Score-matched Analysis. Eur Urol. 2015 Jun;67(6):977-980. doi: 10.1016/j.eururo.2015.01.012. Epub 2015 Jan 19.

  PMID: 25613153 BACKGROUND

• Johnson EL, Marshall JT, Michael GM. A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management. Wound Repair Regen. 2017 Jan;25(1):145-149. doi: 10.1111/wrr.12503. Epub 2017 Jan 19.

  PMID: 27997744 BACKGROUND

• Rodriguez-Collazo E, Tamire Y. Open surgical implantation of a viable cryopreserved placental membrane after decompression and neurolysis of common peroneal nerve: a case series. J Orthop Surg Res. 2017 Jun 12;12(1):88. doi: 10.1186/s13018-017-0587-y.

  PMID: 28606158 BACKGROUND

• Taylor JP, Gearhart S. The use of viable cryopreserved placental tissue in the management of a chronic rectovaginal fistula. Ann R Coll Surg Engl. 2017 Nov;99(8):e236-e240. doi: 10.1308/rcsann.2017.0157. Epub 2017 Oct 19.

  PMID: 29046080 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Results Point of Contact

• Title: Arthur Burnett, MD
• Organization: Johns Hopkins University

aburnet1@jhmi.edu

4106143986

Study Officials

• Arthur Burnett, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center, randomized; singe blinded, two-arm trial comparing the effects of direct placement of lyopreservation placental tissue over the spared neurovascular bundles vs. standard care (no placement of tissue) on erectile recovery and quality of life in patients undergoing bilateral nerve sparing radical prostatectomy for prostate cancer. The sample size will be 30 patients randomized to each study arm (60 patients total).

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: April 1, 2022
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: January 30, 2026
• Results First Posted: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)