Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT05610852
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transvesical Single Port Robotic Partial Prostatectomy — PROCEDURE
    A foley catheter is inserted on the sterile field. A suprapubic midline incision is made and the da Vinci SP surgical system is docked percutaneously directly to the bladder. Prior to the operation, a radiologist identifies and segments tumors and the urethra. A transrectal ultrasound probe is inserted and secured into a fixed position. The Koelis software is utilized to fuse MRI and ultrasound images to identify the target lesion in real-time, allowing for intraoperative guidance. The ultrasound probe rotates automatically, allowing for localization of the tumor intraoperatively. Then depending on the area of the tumor, a Hemi or quadrant resection is completed while preserving the nerves, vas deferens, and seminal vesicles. The urethrovesical anastomosis is then performed.
  • High-intensity focused ultrasound (HIFU) — PROCEDURE
    Three contoured measurements are required for the MR fusion system to reproduce the volume of the prostate. Following this, the area to be targeted will be selected in graded fashion from the anterior to posterior of the prostate. Once planning of ROI (region of interest) is complete, the HIFU treatment may begin. Quadrant or hemi ablation will be performed based on the size and complexity of the tumor. The distal margin of the ablation will be kept at least 4 mm away from the external sphincter. The rectal temperature and its distance from the probe will be carefully monitored throughout the procedure.

Study Details

This study aims to compare the novel single-port robotic partial prostatectomy to High-intensity focused ultrasound (HIFU) in patients with low to intermediate risk localized prostate cancer. These interventions have become acceptable focal therapies prevalent with beneficial oncologic outcomes and therefore need to be examined further.

Key Dates

Start date
Jan 1, 2024
Status verified
May 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2028

Study Design

Enrollment
276 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Transvesical Single Port Robotic Partial Prostatectomy
    Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to Prostatectomy. Prostatectomy consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care.
  • Active Comparator: High-intensity focused ultrasound (HIFU)
    Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to HIFU. HIFU consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care.

Primary Outcome Measure

Recurrence free survival Recurrence free survival [ Time Frame: 1 year after treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer CenterClevelandOhio44195
Jihad Kaouk, MD
[email protected]

Find similar trials in Cleveland, OH

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center· Cleveland, OH

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