Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 19
Healthy Volunteers: f
View:

• Subjects must have histologically or cytologically: Biopsy-confirmed prostate cancer, stage T1a, T2a, T2b, or T2c prostate cancer using MRI staging, with a region of interest (ROI) PIRADs grade 3 or greater, Serum PSA 10 ng/ml or less, Region of interest on MRI of grade 3 or greater

• The MRI performed must include at least:

• A T2-weighted sequence in sections ≤ 4 mm, centered on the prostate and seminal vesicles, at least in the axial plane. Alternatively, a 3D T2-weighted sequence can be realized,

• A diffusion sequence of ≤ 4 mm slice in the axial plane. An ADC card will be provided and calculated from at least two values of b, the maximum value of b being ≥ 600 s / mm2,

• A dynamic sequence after gadolinium injection. It will be a sequence of echo T1-weighted gradient of slice ≤ 4 mm, centered on the prostate and seminal vesicles in the axial plane, with or without fat saturation. A first series will be performed without contrast injection, and will be repeated iteratively for the arrival of a bolus of gadolinium chelates. The time resolution (that is to say, the acquisition time of one dynamic series will be ≤ 20 seconds). The number of chained dynamic series is calculated so that the total length of the dynamic acquisition be at least 3 minutes

• A total dose of 0.1 mmol / kg of gadolinium chelate will be injected at a rate of 3-4 mL / s by using an automatic injector, in a vein of the hand of the forearm or elbow.

• If necessary, subtracted images are calculated

• Clinically significant prostate cancer defined as Gleason score 3+4 or less in any core

• Biopsies for preoperative diagnosis of prostate cancer will have included: At least 12 randomized samples (2 samples per sextant), At least two targeted sampling on each target score MRI ESUR ≥ 3/5

• Life expectancy greater than 10 years.

• Age \>18 years.

• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Locations
United States
Ohio
Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Jihad Kaouk, MD
kaoukj@ccf.org
216-444-2976
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 276
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov