Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

Launched by CASE COMPREHENSIVE CANCER CENTER · Nov 3, 2022

Keywords

ClinConnect Summary

This clinical trial is comparing two treatments for men with localized prostate cancer that is considered low to intermediate risk. The trial is looking at a new method called single-port robotic partial prostatectomy, which is a type of surgery that removes part of the prostate through a small opening, versus a technique known as High-Intensity Focused Ultrasound (HIFU), which uses targeted sound waves to destroy cancer cells. Both treatments are being evaluated to see how well they work and what benefits they provide for patients.

To participate in the trial, men must be at least 18 years old and have been diagnosed with specific stages of prostate cancer. They should have a certain level of cancer found in their biopsy and meet other health criteria, such as not having had prior significant pelvic surgeries or treatments for prostate cancer. If eligible, participants can expect to undergo either the robotic surgery or HIFU treatment, followed by monitoring to assess outcomes. This study is important as it aims to improve treatment options for men facing prostate cancer, helping to determine which method may be more effective and better tolerated.

Gender

MALE

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.