What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as nerve-sparing prostatectomy and radiation therapy, can have side effects including urinary incontinence, erectile dysfunction, and bowel issues. Hormonal therapies may lead to hot flashes, reduced libido, and bone thinning. Treatments like Lyopreserved Placental Tissue (LPT), which aim to promote tissue healing and regeneration, are being studied for their potential to improve recovery outcomes, but specific side effects related to LPT are not well-documented yet.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, focusing on different mechanisms of action. For instance, androgen receptor signaling inhibitors and taxane-based chemotherapies are commonly used. Recently, lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy, was approved for PSMA-positive metastatic castration-resistant prostate cancer. While specific treatments that promote tissue healing and regeneration like Lyopreserved Placental Tissue (LPT) are not highlighted, the general trend in prostate cancer treatment includes a variety of systemic therapies aimed at controlling disease progression and improving patient outcomes.

What other types of research exist?

Promising alternatives to Lyopreserved Placental Tissue (LPT) for prostate cancer patients include: 1) Tissue-engineered repair materials (TERM) using adipose-derived stem cells (ADSCs) on electrospun poly(L-lactide)-trimethylene carbonate-glycolide (PLTG) terpolymers, which have shown better host integration and biomechanical properties. 2) Cryopreserved human amniotic membrane (hAM) scaffold sealed with bio-inspired underwater adhesive, which promotes healing of tissue defects. 3) Platelet-rich plasma (PRP) therapy, which has been shown to improve tissue regeneration and healing by providing concentrated growth factors.

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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

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

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.

0 / 14Eligibility criteria met

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.