Clinical Trials /

AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

NCT04263025

Description:

This study aims at evaluating if placement of CLARIX® CORD 1K during robotic prostatectomy decreases the time to achieve complete erectile and urinary function after the surgery. As part of the study, the patient will be asked to answer various questions after the surgery regarding sexual and urinary function.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft
  • Official Title: Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

Clinical Trial IDs

  • ORG STUDY ID: Pro2019-0452
  • NCT ID: NCT04263025

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
Cryopreserved Umbilical Cord AllograftCLARIX CORD 1K

Purpose

This study aims at evaluating if placement of CLARIX® CORD 1K during robotic prostatectomy decreases the time to achieve complete erectile and urinary function after the surgery. As part of the study, the patient will be asked to answer various questions after the surgery regarding sexual and urinary function.

Detailed Description

      One hundred male patients who are scheduled for bilateral, nerve-sparing RARP that meet the
      eligibility criteria will be enrolled. These patients will be equally randomized (1:1) into
      two groups (n=50/group): one group will receive adjunctive CLARIX® CORD 1K (Amniox Medical,
      Inc., Miami, FL) during RARP, while the other group will undergo RARP without adjunctive
      CLARIX® CORD 1K. Subject stratification will be performed based on the surgeon that will be
      performing the RARP. All patients will be given the same routine preoperative, perioperative
      and postoperative evaluation and care aside from the CLARIX CORD 1K placement in the
      treatment group during RARP. RARP will be performed at Hackensack University Medical Center
      (30 Prospect Ave, Hackensack, NJ 07601) and follow up visits performed at Hackensack
      University Medical Group Urology (360 Essex Street, Suite 403, Hackensack, NJ 07601) or New
      Jersey Urology (255 W. Spring Valley Avenue Suite 101, Maywood, NJ 07607).

      Two weeks prior to the RARP surgery, subjects are instructed to take low-dose oral
      phosphodiesterase type 5 inhibitors (i.e. 20 mg q.d. sildenafil citrate or 5 mg q.d.
      tadalafil) and perform standardized Kegel exercises (3x/day) which is our current standard
      care protocol. RARP surgery will be performed at Hackensack University Medical Center
      (Hackensack, NJ). The following are the key aspects of the RARP surgical technique which will
      be adhered to by all surgeons: 1) dissection of the bladder neck, seminal vesicles and vasa
      deferentia; 2) dissection of the neuroplexus from the posterior Denonvilliers' fascia and
      lateral prostatic fascia leaving the nerves intact; 3) division of the prostatic pedicles
      without cautery; 4) transection of the dorsal venous complex; and 5) urethrovesical
      anastomosis. More specifically, surgical technique includes exposing the prostate in the
      space of Retzius with the traditional anterior approach.

      The prostatovesical tissue is dissected with monopolar electrocautery scissors with entry
      into the bladder proximal to the prostatovesical junction. The bladder neck is transected in
      the standard fashion followed by posterior dissection of the seminal vesicles and vasa
      deferentia.

      Electrocautery is kept to a minimum when dissecting the seminal vesicles to avoid damage to
      the neuroplexus. (Note: each step hereafter must be performed by the PI or Sub-investigators,
      e.g. not a Resident Physician). A posterior surgical plane is then created between the rectum
      and prostate dorsally working from a medial to lateral direction and maintaining at least 1
      layer of Denonvilliers' fascia on the rectal wall. The endopelvic fascia is then excised from
      lateral prostate and carried to capsule to create a plane of dissection immediately alongside
      the prostatic capsule and keeping the nerves attached laterally to the endopelvic fascia.
      Athermal division of each prostatic pedicle will be performed. Clips or suture may be placed
      on each pedicle at the discretion of the surgeon. The apex of the prostate is then dissected
      athermally sparing the neuroplexus. The dorsal vein complex is proximally transected with
      electrocautery while using the fourth arm to place traction on the prostate to define the
      space between the dorsal vein complex and the apex of the prostate. Apically, the prostate is
      divided from the urethra (paying special attention to the sphincter muscle and posterior
      lateral nerve bundle on each side) allowing the prostate to be removed. Once free, the
      prostate is placed in a collection bag and a drain is used for a certain period at the
      discretion of the surgeon.

      Surgical site bleeding is managed using standard surgical techniques with sutures or
      cellulose polymer. If the patient is randomized to the treatment group, CLARIX CORD 1K is
      placed flat over the neuroplexis at the 5 and 7 clock position where the largest
      concentration of nerves exist. Sutures may be used to secure the CLARIX in place if necessary
      and cellulose polymer (Surgicel, Ethicon, Somerville, NJ) can be placed over the CLARIX CORD
      at the discretion of the physician.

      At this point the bladder neck will be reconstructed as necessary to maintain a lumen of
      approximately 30 french. The vesicourethral anastomosis is performed using a V-lock barbed
      suture. The anastomosis will be tested by filling bladder to confirm the absence of leakage.
      If indicated, a bilateral pelvic lymph node dissection is performed (with clips at the
      discretion of the physician) using standard (borders along the external iliac artery and
      vein, obturator fossa, obturator nerve and pubic bone) or extended (borders additionally
      include internal iliac artery) technique at the discretion of the physician. Bleeding will be
      adequately managed. Postoperatively, all subjects are instructed to take low-dose oral
      phosphodiesterase type 5 inhibitors (i.e. 20 mg q.d. sildenafil citrate or 5 mg q.d.
      tadalafil) and perform standardized Kegel exercises (3x/day) following urethral catheter
      removal. When patients are sexually active, they may increase to full dosage of oral
      phosphodiesterase type 5 inhibitors up to twice a week. At 3 months after RARP, and if
      patients have severe or worse incontinence (defined as ICIQ score of >12) and desire
      additional treatment for urinary incontinence,[42] they will undergo pelvic floor therapy.
      Subjects will return for follow up visits at 6 weeks (±1 week), 3 months (±2 weeks), 6 months
      (±3 weeks) and 12 months (±4 weeks) when data will be collected.

      Patient reported outcomes will be assessed including continence, potency, and satisfaction.
      Occurrence of adverse events, number of readmissions, and need for reintervention will also
      be recorded. Measurement of serum PSA levels will also be performed.
    

Trial Arms

NameTypeDescriptionInterventions
CLARIX CORD 1KExperimentalThey will receive adjunctive CLARIX® CORD 1K (Amniox Medical, Inc., Miami, FL) during Robot-Assisted Radical Prostatectomy (RARP).
  • Cryopreserved Umbilical Cord Allograft
ControlsActive ComparatorThey will undergo RARP without adjunctive CLARIX® CORD 1K.

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Male aged between 30 and 70 years old
    
              2. Primary diagnosis of organ confined prostate cancer
    
              3. Scheduled to undergo bilateral, nerve-sparing RARP
    
              4. Patient has ICIQ-SF score <6
    
              5. Patient has no erectile dysfunction (defined as IIEF-6 score ≥ 26)
    
              6. Patient is willing to return for all visits as defined in the protocol
    
              7. Patient is willing to follow the instruction of the Investigator
    
              8. Patient has provided written informed consent
    
            Exclusion Criteria:
    
              1. Previous history of pelvic radiation
    
              2. Previous history of simple prostatectomy or transurethral prostate surgery
    
              3. Previous history of systemic therapy for prostate cancer
    
              4. Patient has neurogenic bladder
    
              5. Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
    
              6. History of open pelvic surgery within 5 years except for hernia repair
    
              7. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone
                 therapy, or open surgery during the study period.
    
              8. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis,
                 etc.) that might confound postsurgical assessments
    
              9. Received administration of an investigational drug within 30 days prior to study,
                 and/or has planned administration of another investigational product or procedure
                 during participation in this study
          
    Maximum Eligible Age:70 Years
    Minimum Eligible Age:30 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Erectile function
    Time Frame:At three months post surgery
    Safety Issue:
    Description:Erectile function will be evaluated using the International Index of Erectile Function (IIEF)

    Secondary Outcome Measures

    Measure:Return to continence
    Time Frame:At three months post surgery
    Safety Issue:
    Description:Continence will be evaluated using the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
    Measure:Return to continence
    Time Frame:At six months post surgery
    Safety Issue:
    Description:Continence will be evaluated using the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
    Measure:Return to continence
    Time Frame:At twelve months post surgery
    Safety Issue:
    Description:Continence will be evaluated using the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
    Measure:Sexual encounter
    Time Frame:At three months post surgery
    Safety Issue:
    Description:Patients will be asked to complete the Sexual Encounter Profile (SEP) Diary to document after each sexual attempt
    Measure:Sexual encounter
    Time Frame:At six months post surgery
    Safety Issue:
    Description:Patients will be asked to complete the Sexual Encounter Profile (SEP) Diary to document after each sexual attempt
    Measure:Sexual encounter
    Time Frame:At twelve months post surgery
    Safety Issue:
    Description:Patients will be asked to complete the Sexual Encounter Profile (SEP) Diary to document after each sexual attempt

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Hackensack Meridian Health

    Trial Keywords

    • Prostate cancer
    • Bilateral, nerve-sparing prostatectomy
    • Prostatectomy

    Last Updated

    February 7, 2020