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NCT05366842 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT05366842: Clinical Trial Phase 2 study, sponsored by Johns Hopkins University.
NCT05366842 is a Phase 2 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05366842, a Phase 2 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- PROCEDURE Radical prostatectomy
- DRUG Stravix lyopreserved placental tissue (LPT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2025-04-25 |
| Phase | Phase 2 |
Why NCT05366842 stopped before completion
NCT05366842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Radical prostatectomy is the first listed.
NCT05366842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05366842 about?
NCT05366842 is a clinical study titled "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". 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 ...
What is the current status of trial NCT05366842?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2022-04-01. Estimated completion is 2025-04-25.
What interventions are being tested in trial NCT05366842?
The interventions under investigation include: Radical prostatectomy (PROCEDURE), Stravix lyopreserved placental tissue (LPT) (DRUG).
Who is sponsoring clinical trial NCT05366842?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05366842's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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