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Prostate CancerPhase 2NCT05366842

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 testing Stravix lyopreserved placental tissue (LPT) and Radical prostatectomy in people with Prostate Cancer, run by Johns Hopkins University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 65 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Stravix lyopreserved placental tissue (LPT) and Radical prostatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
1 siteUnited States
Study dates
1 Apr 2022to 25 Apr 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: 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 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
Being tested
Stravix lyopreserved placental tissue (LPT), Radical prostatectomy
Keywords
erectile dysfunction, radical prostatectomy
Medical subject headings
Prostatic Neoplasms, Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stravix lyopreserved placental tissue (LPT)Drug

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

  • Radical prostatectomyProcedure or surgery

    Standard care (no placement of tissue)

Study groups in NCT05366842
Study groupRoleWhat they receive
StravixExperimentalDirect placement of LPT over the spared neurovascular bundles during bilateral nerve sparing radical prostatectomy for prostate cancer.
Receives: Drug: Stravix lyopreserved placental tissue (LPT)
Standard of CareSham comparatorStandard care (no placement of tissue) bilateral nerve sparing radical prostatectomy for prostate cancer.
Receives: Procedure: Radical prostatectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (1)

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

    The following questionnaires will be combined into a composite index EPIC score. EPIC scoring involves linear standardization of the response for each questionnaire to a 0 to 100 scale. Using the item groupings for each health-related quality of life (HRQOL) Domain Summary Score or Subscale score, values are averaged for all items within a group to create the summary or subscale score. A higher score represents better HRQOL. EPIC scores will be compared at each time point. A clinically relevant increase for the sexual domain is 10-12 points.

    • The Quality of Erection Questionnaire (QEQ) assesses erection in terms of hardness, onset, duration, and changes in erection quality. There are 6 questions.
    • The Short Form Survey (SF-12) assesses 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, etc with 1-2 questions per domain.
    • The MUSIC questionnaire assesses four domains: urinary, bowel, sexual and hormonal. Each domain consists of 2-4 questions.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study start1 Apr 2022
  3. Primary completion25 Apr 2025
  4. Study completion25 Apr 2025

Why it stopped: The sponsor was unable to produce and provide the study material (stravix)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Single blind
Who is masked
Participant
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05366842
Sponsor's protocol ID
IRB00168423
Status last verified
Jan 2026
First submitted
4 May 2022
Last updated
30 Jan 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25613153

  • 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.

    PubMed 27997744

  • 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.

    PubMed 28606158

  • 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.

    PubMed 29046080

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stravix lyopreserved placental tissue (LPT) and Radical prostatectomy in people with Prostate Cancer, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Erectile Function as Assessed by the International Index of Erectile Function (IIEF) Score (time frame: 1, 3, 6, 9, 12 and 18 months post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05366842, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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