Placental Tissue Application for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing whether using preserved placental tissue during prostate cancer surgery can help men recover sexual function and bladder control better. The tissue is placed over nerves to protect and heal them. Men with good sexual function before surgery are being studied.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking nitrate medications or have certain health conditions. It's best to discuss your specific medications with the trial team.
How is the treatment Lyopreserved Placental Tissue (LPT) unique for prostate cancer?
Lyopreserved Placental Tissue (LPT) is unique because it uses placental tissue, which is known for its regenerative properties, to potentially aid in healing and tissue regeneration. This approach is different from traditional prostate cancer treatments, which typically involve surgery, radiation, or chemotherapy, as it leverages the natural healing components of the placenta.12345
Who Is on the Research Team?
Arthur L Burnett
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo nerve-sparing robotic prostatectomy with or without LPT placement
Follow-up
Participants report erectile function and continence at multiple time points post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Lyopreserved Placental Tissue (LPT)
Lyopreserved Placental Tissue (LPT) is already approved in United States for the following indications:
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Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor