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Tissue Graft

Placental Tissue Application for Prostate Cancer

Phase 2

Recruiting

Led By Arthur Burnett, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Has a sexual partner of at least 6 months with current sexual activity (within the past 4 weeks)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will study whether placing tissue from the placenta over nerves during surgery to remove the prostate improves sexual function and continence after surgery.

Who is the study for?

Men aged 40-65 with good pre-surgery erectile function and localized prostate cancer (stage ≤ T2a, Gleason grade ≤ 7, PSA ≤ 10 ng/mL) planning a nerve-sparing robotic prostatectomy. Must be sexually active with a partner of at least 6 months and willing to attempt intercourse frequently post-surgery. Excludes those with uncontrolled blood pressure, certain medication use, spinal/brain surgery history, known sensitivities to specific reagents, substance abuse issues, heavy smoking history, penile deformity/Peyronie's disease, severe depression or organ problems.Check my eligibility

What is being tested?

The trial is testing if applying Stravix lyopreserved placental tissue over neurovascular bundles during nerve-sparing robotic prostatectomy improves sexual and urinary functions compared to standard care. Men will report their erectile function and continence up to one year after surgery. The study aims to see how quickly men regain potency and continence.See study design

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include typical surgical risks such as infection or reactions related to the implanted placental tissue like inflammation or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged 40-65 with early-stage prostate cancer and a PSA of 10 or less.

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I have been sexually active with my partner of 6+ months recently.

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I am scheduled for a prostate surgery that aims to preserve nerve function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 9, 12 and 18 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in erectile function as assessed by the International Index of Erectile Function (IIEF) Score

Secondary outcome measures

Change in erectile function and overall quality of life as assessed by the Expanded Prostate cancer Index Composite (EPIC) score from questionnaires

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: StravixExperimental Treatment1 Intervention

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

Group II: Standard of CarePlacebo Group1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,261 Previous Clinical Trials

14,821,008 Total Patients Enrolled

28 Trials studying Prostate Cancer

12,091 Patients Enrolled for Prostate Cancer

Arthur Burnett, MDPrincipal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

116 Total Patients Enrolled

Media Library

Lyopreserved Placental Tissue (LPT) (Tissue Graft) Clinical Trial Eligibility Overview. Trial Name: NCT05366842 — Phase 2

Prostate Cancer Research Study Groups: Stravix, Standard of Care

Prostate Cancer Clinical Trial 2023: Lyopreserved Placental Tissue (LPT) Highlights & Side Effects. Trial Name: NCT05366842 — Phase 2

Lyopreserved Placental Tissue (LPT) (Tissue Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05366842 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment accepting new participants?

"Affirmative. According to the information posted on clinicaltrials.gov, this research trial is actively searching for participants who meet its criteria; it was initially uploaded on April 1st 2022 and last updated a few weeks later. The study requires 60 individuals at one single site."

Answered by AI

Has Stravix's lyopreserved placental tissue (LPT) cleared regulatory review by the FDA?

"Stravix lyopreserved placental tissue (LPT) has been awarded a safety rating of 2, as there is prior evidence to support its security but not yet any proof of efficacy."

Answered by AI

How many participants are enrolled in this clinical investigation?

"Affirmative. The data hosted on clinicaltrials.gov affirms that this medical research, which was initially published on April 1st 2022, is actively recruiting individuals to participate in the study. Sixty participants from one site need to be recruited for the trial's completion."

Answered by AI

Is it possible for me to join this research trial?

"This clinical trial seeks to enrol 60 male participants aged between 40 and 65 with prostate cancer. The medical criteria for admission includes a localised stage of T2a or lower, Gleason grade up to 7 (Gleason 8 or 4+3=7 excluded), PSA level no higher than 10 ng/mL, scheduled curative radical prostatectomy using bilateral nerve-sparing procedure, intact pre-operative erectile functioning as measured by the IIEF-5/SHIM score greater than 18, willingness to engage in intercourse at least 5 times per month post-surgery and having an active sexual partner for 6 months minimum"

Answered by AI

Are participants aged 35 and above eligible for this experiment?

"This clinical trial is only open to participants between the ages of 40 and 65. Individuals younger than 18 are able to participate in 52 other trials, while 830 studies cater for those over 65 years old."

Answered by AI

Recent research and studies

Wound Repair and RegenerationJournal

A Comparative Outcomes Analysis Evaluating Clinical Effectiveness in Two Different Human Placental Membrane Products for Wound Management

Johnson, Eric L., James T. Marshall, and Georgina M. Michael. 2017. “A Comparative Outcomes Analysis Evaluating Clinical Effectiveness in Two Different Human Placental Membrane Products for Wound Management”. Wound Repair and Regeneration. Wiley. doi:10.1111/wrr.12503.

European UrologyJournal

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

Patel, Vipul R., Srinivas Samavedi, Anthony S. Bates, Anup Kumar, Rafael Coelho, Bernardo Rocco, and Kenneth Palmer. 2015. “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”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2015.01.012.

Journal of Orthopaedic Surgery and ResearchJournal

Open Surgical Implantation of a Viable Cryopreserved Placental Membrane After Decompression and Neurolysis of Common Peroneal Nerve: A Case Series

Rodriguez-Collazo, E., and Y. Tamire. 2017. “Open Surgical Implantation of a Viable Cryopreserved Placental Membrane After Decompression and Neurolysis of Common Peroneal Nerve: A Case Series”. Journal of Orthopaedic Surgery and Research. Springer Science and Business Media LLC. doi:10.1186/s13018-017-0587-y.

The Annals of The Royal College of Surgeons of EnglandJournal