Comparing single-port robotic prostate surgery to high-intensity focused ultrasound for prostate cancer

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

This study is testing whether single-port robotic surgery or high-intensity focused ultrasound is better for treating localized prostate cancer in men with low to intermediate risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 276 (estimated)
• Ages: 19 Years and up
• Sex: Male
• Sponsor: Case Comprehensive Cancer Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT05610852 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of single-port robotic partial prostatectomy with high-intensity focused ultrasound (HIFU) in patients diagnosed with low to intermediate risk localized prostate cancer. The primary focus is on evaluating recurrence rates and recurrence-free survival, determined through prostate MRI and targeted biopsies. Secondary objectives include assessing perioperative parameters, functional outcomes such as urinary continence and erectile function, and oncologic outcomes like biochemical recurrence rates and the need for secondary interventions.

Who should consider this trial

Good fit: Ideal candidates for this study are men with biopsy-confirmed prostate cancer at stages T1a to T2c and specific MRI findings indicating localized disease.

Not a fit: Patients with advanced prostate cancer or those not meeting the specific MRI and biopsy criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a more effective treatment option for localized prostate cancer, potentially leading to better oncologic outcomes and improved quality of life.

How similar studies have performed: Other studies have shown promising results with both single-port robotic surgery and HIFU, indicating that this comparative approach is relevant and potentially beneficial.

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.

Where this trial is running

Cleveland, Ohio

• Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Jihad Kaouk, MD — Glickman Urological & Kidney Institute: Professor of Urology
• Study coordinator: Jihad Kaouk, MD

Conditions Prostate Adenocarcinoma; Prostate Cancer; High Intensity Focused Ultrasound; Single-Port Transvesical Partial Prostatectomy