Cryopreserved Umbilical Cord Graft + Robotic Surgery for Prostate Cancer

Recruiting at 1 trial location

Overseen By Sharon Seidman, RN

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: Hackensack Meridian Health

Disqualifiers: Pelvic radiation, Prostate surgery, Neurogenic bladder, Neurologic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special umbilical cord graft (Cryopreserved Umbilical Cord Allograft) used during robotic prostate surgery can help men recover faster in sexual and urinary functions. The study involves two groups: one receiving the graft and the other undergoing surgery without it. This trial suits men diagnosed with prostate cancer that hasn't spread and who plan to undergo Robot-Assisted Radical Prostatectomy. Participants should not have existing erectile or urinary problems. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are scheduled for chemotherapy, radiation, hormone therapy, or open surgery during the study, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using CLARIX® CORD 1K, a preserved umbilical cord tissue, with robotic surgery is safe for patients. A study at one medical center found that this treatment helps patients regain urinary control faster after surgery, without major side effects. Although more research is needed, current evidence suggests that adding CLARIX® CORD 1K to surgery is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using a cryopreserved umbilical cord graft, known as CLARIX® CORD 1K, in conjunction with robotic surgery for prostate cancer because it introduces a novel approach to healing and recovery. Unlike standard treatments that rely solely on surgery, this method uses the biological properties of the umbilical cord to potentially enhance tissue repair and reduce inflammation. By integrating this innovative graft with robot-assisted surgery, there is hope for improved post-surgical outcomes and quicker recovery times, offering a promising advancement over traditional methods.

What evidence suggests that the Cryopreserved Umbilical Cord Allograft is effective for improving erectile and urinary function after robotic prostatectomy?

This trial will compare two approaches for prostate cancer surgery. One group will receive Robot-Assisted Radical Prostatectomy (RARP) with adjunctive CLARIX® CORD 1K, a preserved umbilical cord tissue. Studies have shown that using CLARIX® CORD 1K during robotic prostate surgery can help patients recover faster. Specifically, research suggests it aids in regaining bladder control more quickly after surgery. Initial findings indicated that the tissue is safe and may improve recovery times. This method is being studied to determine if it helps patients regain erectile function and urinary control faster after surgery. Meanwhile, the control group will undergo RARP without adjunctive CLARIX® CORD 1K. ^{2 3 4 5 6}

Who Is on the Research Team?

Michael Stifelman, MD

Principal Investigator

Chair of Urology Department

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for a prostate surgery that preserves nerve function.

Patient has ICIQ-SF score <6

Patient has no erectile dysfunction (defined as IIEF-6 score ≥ 26)

Exclusion Criteria

I have had radiation therapy to my pelvic area before.

I have not had pelvic surgery in the last 5 years, except for hernia repair.

I have a condition where my bladder doesn't function properly due to nerve damage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Subjects take low-dose oral phosphodiesterase type 5 inhibitors and perform standardized Kegel exercises

2 weeks

Treatment

Robot-Assisted Radical Prostatectomy (RARP) with or without adjunctive CLARIX® CORD 1K

1 day

1 visit (in-person)

Postoperative Care

Postoperative instructions include taking low-dose oral phosphodiesterase type 5 inhibitors and performing Kegel exercises

3 months

Follow-up

Participants are monitored for continence, potency, and satisfaction, with follow-up visits at 6 weeks, 3 months, 6 months, and 12 months

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cryopreserved Umbilical Cord Allograft
• Robot-Assisted Radical Prostatectomy

Trial Overview 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.

How Is the Trial Designed?

Group I: CLARIX CORD 1K Experimental Treatment 2 Interventions

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

Group II: Controls Active Control 1 Intervention

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

Robot-Assisted Radical Prostatectomy is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Robotic Prostatectomy for:

• Localized prostate cancer

Approved in United States as Robot-Assisted Laparoscopic Prostatectomy for:

• Localized prostate cancer

Approved in Canada as Robotic-Assisted Radical Prostatectomy for:

• Localized prostate cancer

Approved in Japan as Robotic Prostatectomy for:

• Localized prostate cancer

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Published Research Related to This Trial

Robotic-assisted laparoscopic radical prostatectomy was successfully performed on a 73-year-old kidney transplant recipient with localized prostate cancer, demonstrating that this surgical approach is safe and feasible for patients with prior kidney transplants.

The use of the Retzius space preservation technique minimized manipulation of the transplanted kidney, leading to favorable outcomes such as stable renal function and normal urinary continence post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retzius Space Preservation Technique for Robotic-Assisted Laparoscopic Radical Prostatectomy in a Kidney Transplant Patient: First Case in Thailand and Our First Experience. Jenjitranant, P., Sangkum, P., Sirisreetreerux, P., et al.[2022]

In a study of 200 patients who underwent nerve-sparing radical prostatectomy, those who received a cryopreserved umbilical cord allograft around the neurovascular bundles had significantly higher rates of continence recovery at 1 month (65% vs. 44%) and 12 months (97% vs. 87%) compared to those who did not receive the graft.

The use of umbilical cord allograft was found to be safe, with no adverse events or complications reported, and it particularly benefited high-risk groups such as obese patients and those over 60 years old.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-center, retrospective review of robot-assisted laparoscopic prostatectomy with and without cryopreserved umbilical cord allograft in improving continence recovery. Ahmed, M., Esposito, M., Lovallo, G.[2020]

Robotic-assisted radical prostatectomy offers significant advantages over traditional open surgery, including smaller incisions, reduced blood loss, and shorter hospital stays, making it a safer option for patients.

The technology enhances the surgeon's ability to perform precise movements, which helps in preserving nerves, leading to better outcomes in urinary continence and sexual function after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted laparoscopic radical prostatectomy. Rigdon, JL.[2019]

Robotic radical prostatectomy has been established as a feasible and effective method for treating localized prostate cancer in young patients, improving precision and accuracy compared to traditional laparoscopic techniques.

The review focuses on the European experience, highlighting advancements in robotic technology that enhance surgical outcomes for patients undergoing this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic radical prostatectomy: the European experience. Cathelineau, X., Rozet, F., Vallancien, G.[2004]

This study reports the first experience in Russia and Eastern Europe of performing robot-assisted radical prostatectomy for localized prostate cancer in three patients who had undergone heart transplantation, indicating a new treatment avenue for this high-risk group.

The procedure was found to be safe and effective, with all patients discharged in satisfactory condition and no biochemical recurrences of prostate cancer during the follow-up period, suggesting promising early outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experience in performing robot-assisted radical prostatectomy in patients after heart transplan- tation]. Mosoyan, MS., Shelipanov, DA., Fedotov, PA., et al.[2023]

A 67-year-old male patient who underwent robot-assisted radical prostatectomy with dehydrated umbilical cord allograft showed significant recovery, reporting minimal urinary incontinence and 75% erectile rigidity just four weeks post-surgery.

By three months after the procedure, the patient achieved full continence and 100% erectile rigidity, suggesting that umbilical cord allografts may facilitate faster recovery of urinary and sexual function after prostate surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early return to continence and potency with use of dehydrated human umbilical cord graft at the time of robot-assisted radical prostatectomy: A case study and analysis of relevant literature. Krol, BC., Hemal, AK., Peak, T., et al.[2022]

Robot-assisted radical prostatectomy (RARP) was successfully performed on 3 renal transplant recipients (RTRs) with localized prostate cancer, showing no major complications and stable graft function during and after the procedure.

The procedure had a mean operation time of 162 minutes and minimal blood loss (52 mL), indicating that RARP is a feasible and effective minimally invasive option for treating localized prostate cancer in carefully selected RTRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Radical Prostatectomy for Localized Prostate Cancer in Asian Renal Transplant Recipients. Iizuka, J., Hashimoto, Y., Kondo, T., et al.[2018]

In a study of 210 patients undergoing robotic radical prostatectomy, 26% experienced complications, with 87% classified as minor, indicating a generally low morbidity associated with this surgical method.

The complication rate for robotic surgery appears to be lower than that of traditional open radical prostatectomy, suggesting that robotic techniques may offer safer outcomes as surgeons gain experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of robotic assisted radical prostatectomy. Fischer, B., Engel, N., Fehr, JL., et al.[2022]

Robot-assisted radical prostatectomy in older men has not yet been proven effective for controlling cancer or improving functional and voiding outcomes.

There is evidence suggesting that radical surgery may not be the best option for older men, although the trend in treatment is moving towards this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Mortality in the Ageing Patient: Treatment of the Primary Tumour Is Not Necessary. Lamb, AD., Brewster, SF., Hamdy, FC.[2018]

Robot-assisted laparoscopic prostatectomy can be safely performed in a renal allograft recipient, as demonstrated in a case study of a 54-year-old man with localized prostate cancer, showing favorable outcomes.

The patient experienced successful oncological results with negative surgical margins, regained urinary continence within a week, and achieved erectile function sufficient for penetration by the 6-week follow-up, indicating the procedure's efficacy and safety in this unique patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic radical prostatectomy in the renal allograft transplant recipient. Jhaveri, JK., Tan, GY., Scherr, DS., et al.[2016]

Robot-assisted radical prostatectomy (RARP) is a safe and feasible surgical option for prostate cancer removal in patients with a history of kidney transplants, as demonstrated in a case study of a 62-year-old patient with no postoperative complications and successful outcomes.

The procedure resulted in favorable oncological and functional results, including complete continence and normal kidney function during a 21-month follow-up, highlighting the importance of routine prostate-specific antigen screening for early detection of prostate cancer in post-kidney transplant males.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Radical Prostatectomy in a Post-Kidney Transplant Patient: An Initial Case Report in China. Fang, Y., Chen, Z., Juan, L., et al.[2019]

Robot-assisted laparoscopic radical prostatectomy (RALP) has similar positive surgical margin rates compared to traditional open and laparoscopic surgeries, indicating its safety and effectiveness in treating organ-confined prostate cancer.

While RALP shows excellent short-term oncological control, long-term outcomes such as biochemical disease-free survival are still unclear, highlighting the need for larger studies with extended follow-up to fully assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radical robot prostatectomy: oncological outcomes]. Rodríguez, E., Skarecky, DW., Ahlering, TE.[2007]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04263025

AMNIOX CORD Study - Radical Prostatectomy With and ... This study aims at evaluating if placement of CLARIX® CORD 1K during robotic prostatectomy decreases the time to achieve complete erectile and urinary function ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7125058/

A single-center, retrospective review of robot-assisted ... The results suggest that UC allograft is safe and accelerates continence recovery in post-RARP patients. Prospective, randomized trials are warranted.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-05198

Evaluation of Erectile and Urinary Function following ... This phase III trial compares the effect of adding cryopreserved umbilical cord allograft (CLARIX CORD 1K [registered trademark]) to robot-assisted radical ...

4. urologytimes.com urologytimes.com/view/can-cryopreserved-umbilical-cord-allograft-improve-post-rarp-continence-recovery

Can cryopreserved umbilical cord allograft improve post- ... A new trial is exploring whether CLARIX CORD 1K, a cryopreserved umbilical cord allograft, can contribute to a faster return of erectile function and urinary ...

5. withpower.com withpower.com/trial/phase-prostatic-neoplasms-2020-04bbd

Cryopreserved Umbilical Cord Graft + Robotic Surgery for ... This trial is testing if using CLARIX® CORD 1K during robotic prostate surgery helps men recover their erectile and urinary functions faster.

6. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04263025/

Clinical Trial: NCT04263025 This study aims at evaluating if placement of CLARIX® CORD 1K during robotic prostatectomy decreases the time to achieve complete erectile and urinary function ...