What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly radical prostatectomy, often result in side effects such as urinary incontinence and erectile dysfunction. These side effects can significantly impact the patient's quality of life. Urinary incontinence may manifest as a weak stream, frequency, nocturia, and straining, while erectile dysfunction can affect sexual function. The CLARIX® CORD 1K study aims to evaluate whether the use of cryopreserved umbilical cord allograft can enhance healing and reduce the time to recover these functions post-surgery.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including androgen receptor signaling inhibitors like enzalutamide and taxane-based chemotherapies such as docetaxel. Additionally, radium-223 has been approved for its ability to target bone metastases with a favorable safety profile. While these treatments primarily focus on controlling cancer progression and managing symptoms, regenerative therapies like CLARIX® CORD 1K, which aim to enhance healing and functional recovery post-surgery, represent a novel approach that is still under investigation.

What other types of research exist?

One promising alternative to CLARIX® CORD 1K for prostate cancer patients is the use of stem cell treatments, which are thought to functionally regenerate the urethral sphincter and potentially improve urinary function. Additionally, the Rezum® water vapor therapy system has shown significant efficacy in improving urinary symptoms and quality of life without serious side effects, making it another viable option for enhancing functional recovery.

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Cryopreserved Umbilical Cord Graft + Robotic Surgery for Prostate Cancer

Phase 2 & 3

Recruiting

Led By Michael Stifelman, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post op

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if using CLARIX® CORD 1K during robotic prostate surgery helps men recover their erectile and urinary functions faster. The product is placed over nerves to protect and heal them. The study involves male patients undergoing this type of surgery.

Who is the study for?

Men aged 30-70 with organ-confined prostate cancer, no erectile dysfunction, and good urinary function are eligible. They must be scheduled for nerve-sparing robotic prostatectomy, agree to follow-up visits and instructions, and have not had certain prior treatments or surgeries.

What is being tested?

The study tests if using CLARIX® CORD 1K during robot-assisted radical prostatectomy can speed up the return of complete erectile and urinary function post-surgery. Participants will provide feedback on their sexual and urinary health after the procedure.

What are the potential side effects?

While specific side effects aren't listed for this trial, typical risks may include surgical complications like infection or bleeding, reaction to materials used in surgery (CLARIX® CORD), and potential delays in recovery of erectile/urinary functions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Erectile function

Secondary study objectives

Biochemical recurrence endpoint

Failure Events of Following RARP endpoint

Pad Count

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CLARIX CORD 1KExperimental Treatment2 Interventions

They will receive adjunctive CLARIX® CORD 1K (Amniox Medical, Inc., Miami, FL) during Robot-Assisted Radical Prostatectomy (RARP).

Group II: ControlsActive Control1 Intervention

They will undergo RARP without adjunctive CLARIX® CORD 1K.

Do I qualify?Apply below to find out

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 prevent cancer growth, and focal therapies like cryotherapy and high-intensity focused ultrasound (HIFU) that target specific cancer areas while sparing healthy tissue. Regenerative treatments, such as the use of cryopreserved umbilical cord allografts (e.g., CLARIX® CORD 1K), aim to enhance healing and functional recovery post-surgery by leveraging the regenerative properties of the allograft to reduce inflammation and promote tissue repair. These approaches are crucial for prostate cancer patients as they not only target the cancer but also aim to preserve and restore urinary and sexual functions, significantly improving quality of life post-treatment.

Functional impact of androgen-targeted therapy on patients with castration-resistant prostate cancer.Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI.Effects of resistance exercise in prostate cancer patients: a meta-analysis.