NCT05610852 Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound
| NCT ID | NCT05610852 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Prostate Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 276 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 276 participants in total. It began in 2024-01-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion 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. Exclusion Criteria: * 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.
Contact & Investigator
Jihad Kaouk, MD
PRINCIPAL INVESTIGATOR
Glickman Urological & Kidney Institute: Professor of Urology
Frequently Asked Questions
Who can join the NCT05610852 clinical trial?
This trial is open to male participants only, aged 19 Years or older, studying Prostate Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05610852 currently recruiting?
Yes, NCT05610852 is actively recruiting participants. Contact the research team at kaoukj@ccf.org for enrollment information.
Where is the NCT05610852 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05610852 clinical trial?
NCT05610852 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Jihad Kaouk, MD at Glickman Urological & Kidney Institute: Professor of Urology. The trial plans to enroll 276 participants.