Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

Case Comprehensive Cancer Center (Case CCC)

Status: Enrolling

Conditions: Prostate Adenocarcinoma; Prostate Cancer

Treatments: Procedure: High-intensity focused ultrasound (HIFU); Procedure: Transvesical Single Port Robotic Partial Prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05610852

CASE10822

Details and patient eligibility

About

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.

Full 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)

Enrollment: 276 estimated patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

Transvesical Single Port Robotic Partial Prostatectomy

Active Comparator group

Description:

Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to Prostatectomy. Prostatectomy consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care.

Treatment:

Procedure: Transvesical Single Port Robotic Partial Prostatectomy

High-intensity focused ultrasound (HIFU)

Active Comparator group

Description:

Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to HIFU. HIFU consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care.

Treatment:

Procedure: High-intensity focused ultrasound (HIFU)