Focal Therapy (Transvesical Single-Port Robotic Partial Prostatectomy versus High-Intensity Focused Ultrasound) for the Treatment of Patients with Prostate Cancer

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) Prostate Imaging-Reporting and Data System (PIRADs) grade 3 or greater
• Serum PSA 10 ng/ml or less
• Region of interest on mpMRI 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 3-dimenstional (3D) T2-weighted sequence can be realized, ** A diffusion sequence of ≤ 4 mm slice in the axial plane. An apparent diffusion coefficient (ADC) card will be provided and calculated from at least two values of b, the maximum value of b being ≥ 600 s / mm^2, ** 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 European Society of Urogenital Radiology (ESUR) ≥ 3/5
• Tumor location within 35mm from the rectal wall and at least 4mm from the urinary sphincter
• Subjects with Gleason 3+3=6 prostate cancer not suitable for active surveillance may also be included such as those with high volume disease, high-risk genomic testing, strong family history, or patient preference for treatment
• Patients should be of acceptable surgical risk during routine preoperative clearance testing prior to operative intervention with no contraindications.
• 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)
• Subjects with Gleason 3+3=6 prostate cancer who are suitable candidates for active surveillance
• Other factors including: * Biopsy results do not correlate with MRI imaging findings * 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 * Subjects with sexual dysfunction defined as Sexual Health Inventory for Men (SHIM) score < 17