RECRUITING

Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

Conditions

Prostate Adenocarcinoma Prostate Cancer High Intensity Focused Ultrasound (HIFU)Single-Port Transvesical Partial Prostatectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-01

Study Completion:2028-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05610852

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* Patients with any prior extensive pelvic surgery, pelvic fractures, hemorrhoid, fissure surgery, cardiac pacemaker, or metal prosthesis * Prior treatment for prostate cancer such as radiotherapy, focal or hormonal therapy * Uncorrected coagulopathy or history of Latex allergy * Active soft tissue or urinary infection, indwelling Foley catheter or severe irritative or obstructive symptoms * Poor surgical risk (defined as American Society of Anesthesiology score \> 3). * Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.) * Prostate size larger than 80 grams. * Subjects with prostatic Calcification (\>0.5 cc) close to the area to be treated. * Subjects with extraprostatic extension or cribriform pattern on biopsy. * Subjectes with sexual dysfunction defined as SHIM score \< 17 * Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Inclusion Criteria

Exclusion Criteria

* 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.

* Patients with any prior extensive pelvic surgery, pelvic fractures, hemorrhoid, fissure surgery, cardiac pacemaker, or metal prosthesis
* Prior treatment for prostate cancer such as radiotherapy, focal or hormonal therapy
* Uncorrected coagulopathy or history of Latex allergy
* Active soft tissue or urinary infection, indwelling Foley catheter or severe irritative or obstructive symptoms
* Poor surgical risk (defined as American Society of Anesthesiology score \> 3).
* Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.)
* Prostate size larger than 80 grams.
* Subjects with prostatic Calcification (\>0.5 cc) close to the area to be treated.
* Subjects with extraprostatic extension or cribriform pattern on biopsy.
* Subjectes with sexual dysfunction defined as SHIM score \< 17
* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Contacts and Locations

Study Contact

Jihad Kaouk, MD

CONTACT

216-444-2976

kaoukj@ccf.org

Principal Investigator

Jihad Kaouk, MD

PRINCIPAL_INVESTIGATOR

Glickman Urological & Kidney Institute: Professor of Urology

Study Locations (Sites)

Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

Jihad Kaouk, MD, PRINCIPAL_INVESTIGATOR, Glickman Urological & Kidney Institute: Professor of Urology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01

Study Completion Date2028-07-01

Study Record Updates

Study Start Date2024-01-01

Study Completion Date2028-07-01

Terms related to this study

Keywords Provided by Researchers

High Intensity Focused Ultrasound (HIFU)
Single-Port Transvesical Partial Prostatectomy

Additional Relevant MeSH Terms

Prostate Adenocarcinoma
Prostate Cancer