Clinical trial NCT05610852: Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound
Official title: Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Adenocarcinoma
Prostate Cancer
Keywords: High Intensity Focused Ultrasound (HIFU)
Single-Port Transvesical Partial Prostatectomy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 276
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The primary objective is to evaluate the in-field recurrence rates and recurrence free survival - defined as the absence of clinically significant prostate cancer within the treated zone (identified by prostate MRI and subsequent targeted prostate biopsy).

Secondary objectives of interest are:

* Perioperative parameters such as operative time, perioperative complications, analgesic requirement, postoperative hospital stay, foley catheter duration
* Functional outcomes such as time to urinary continence, urinary continence, and erectile dysfunction
* Oncologic outcomes such as biochemical recurrence rates (defined in section 2.1), recurrence free survival, presence of secondary intervention for prostate cancer (HIFU, radiation, surgery, ADT)

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.

Primary outcomes:
measure: Recurrence free survival Recurrence free survival
timeFrame: 1 year after treatment
measure: Recurrence free survival
timeFrame: 2 years after treatment
measure: Recurrence free survival
timeFrame: 3 years after treatment
Secondary outcomes:
measure: Operative time
timeFrame: At initial treatment (postoperative day 0)
measure: Postoperative Complications
timeFrame: Within 3 months after treatment.
measure: Analgesic requirment
timeFrame: Once at first follow up (up to 7 days after initial treatment)
measure: Postoperative hospital stay
timeFrame: Up to 1 day after initial treatment
measure: Foley catheter duration
timeFrame: Up to 7 days after initial treatment
measure: Time to urinary continence
timeFrame: Assessed at each visit for up to 1 year after treatment
measure: Urinary continence
timeFrame: Assessed at each visit for up to 1 year after treatment
measure: Erectile dysfunction
timeFrame: Assessed at each visit for up to 3 years
measure: Biochemical recurrence
timeFrame: Assessed at each visit for up to 3 years
measure: Secondary interventions
timeFrame: Assessed at the time of clinic visits up to 3 years after treatment.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Glickman Urological & Kidney Institute: Professor of Urology
name: Jihad Kaouk, MD
role: PRINCIPAL_INVESTIGATOR
References: