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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)
Must not have
Current smoker has a 20 pack/year history of cigarette smoking
History of retinitis pigmentosa or severe vision loss, including a condition called NAION
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6, 9, 12 and 18 months post-surgery
Summary
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.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have smoked a pack of cigarettes a day for 20 years.
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I have a history of severe vision loss or specific eye conditions.
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I have a history of heart issues like angina or heart failure.
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I cannot take PDE5 inhibitors due to health reasons.
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My blood pressure is not well-controlled.
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I have had radiation therapy before or after surgery.
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I am undergoing hormone therapy before or after surgery.
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I have had surgery or injury to my brain or spine.
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I am currently taking medication that contains nitrates.
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I have a history of depression.
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I have had liver or kidney problems in the past.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in erectile function as assessed by the International Index of Erectile Function (IIEF) Score
Secondary study objectives
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces androgen levels to slow cancer growth, and platelet-rich plasma (PRP), which may aid in tissue healing and erectile function preservation post-surgery. Lyopreserved Placental Tissue (LPT) is being studied for its potential to enhance tissue healing and regeneration by providing a scaffold and growth factors, which could improve outcomes in nerve-sparing prostatectomy.
These treatments are crucial as they target different aspects of cancer progression and recovery, offering a multifaceted approach to managing prostate cancer and improving patients' quality of life.
Regulation of prostatic carcinoma cell proliferation and secretory activity by extracellular matrix and stromal secretions.Peri-Prostatic Adipocyte-Released TGFβ Enhances Prostate Cancer Cell Motility by Upregulation of Connective Tissue Growth Factor.Inhibition of prostatic epithelial cell proliferation by a factor secreted specifically by prostatic stromal cells.
Regulation of prostatic carcinoma cell proliferation and secretory activity by extracellular matrix and stromal secretions.Peri-Prostatic Adipocyte-Released TGFβ Enhances Prostate Cancer Cell Motility by Upregulation of Connective Tissue Growth Factor.Inhibition of prostatic epithelial cell proliferation by a factor secreted specifically by prostatic stromal cells.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,613 Total Patients Enrolled
28 Trials studying Prostate Cancer
12,168 Patients Enrolled for Prostate Cancer
Arthur Burnett, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
116 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have smoked a pack of cigarettes a day for 20 years.I have a history of severe vision loss or specific eye conditions.You are willing to have sex at least 5 times per month after the surgery.I have a history of heart issues like angina or heart failure.I cannot take PDE5 inhibitors due to health reasons.My blood pressure is not well-controlled.I have had radiation therapy before or after surgery.I am a man aged 40-65 with early-stage prostate cancer and a PSA of 10 or less.I am undergoing hormone therapy before or after surgery.I have had surgery or injury to my brain or spine.I have been sexually active with my partner of 6+ months recently.You have a history of using drugs or drinking too much alcohol.I am currently taking medication that contains nitrates.I am scheduled for a prostate surgery that aims to preserve nerve function.You have a curved penis or have had a condition called Peyronie's disease in the past.I have a history of depression.I have had liver or kidney problems in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Stravix
- Group 2: Standard of Care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.