Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

Inclusion Criteria:

• Subjects must have histologically or cytologically: Biopsy-confirmed prostatecancer, stage T1a, T2a, T2b, or T2c prostate cancer using MRI staging, with a regionof interest (ROI) PIRADs grade 3 or greater, Serum PSA 10 ng/ml or less, Region ofinterest 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 seminalvesicles, at least in the axial plane. Alternatively, a 3D T2-weighted sequence canbe realized,

• A diffusion sequence of ≤ 4 mm slice in the axial plane. An ADC card will beprovided 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 echoT1-weighted gradient of slice ≤ 4 mm, centered on the prostate and seminal vesiclesin the axial plane, with or without fat saturation. A first series will be performedwithout contrast injection, and will be repeated iteratively for the arrival of abolus of gadolinium chelates. The time resolution (that is to say, the acquisitiontime of one dynamic series will be ≤ 20 seconds). The number of chained dynamicseries 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 orelbow.

• If necessary, subtracted images are calculated

• Clinically significant prostate cancer defined as Gleason score 3+4 or less in anycore

• Biopsies for preoperative diagnosis of prostate cancer will have included: At least 12 randomized samples (2 samples per sextant), At least two targeted sampling oneach 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 writteninformed 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 severeirritative 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 theinvestigator, might confound the results of the study or pose additional risk to thepatient (e.g. significant cardiovascular conditions that significantly affect thelife 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 toongoing or active infection, symptomatic congestive heart failure, unstable anginapectoris, cardiac arrhythmia, or psychiatric illness/social situations that wouldlimit compliance with study requirements.