Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age19+
SponsorCase Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transvesical Single Port Robotic Partial Prostatectomy
Procedure/SurgeryA foley catheter is inserted on the sterile field. A suprapubic midline incision is made and the da Vinci SP surgical system is docked percutaneously directly to the bladder. Prior to the operation, a radiologist identifies and segments tumors and the urethra. A transrectal ultrasound probe is inserted and secured into a fixed position. The Koelis software is utilized to fuse MRI and ultrasound images to identify the target lesion in real-time, allowing for intraoperative guidance. The ultrasound probe rotates automatically, allowing for localization of the tumor intraoperatively. Then depending on the area of the tumor, a Hemi or quadrant resection is completed while preserving the nerves, vas deferens, and seminal vesicles. The urethrovesical anastomosis is then performed.
High-intensity focused ultrasound (HIFU)
Procedure/SurgeryThree contoured measurements are required for the MR fusion system to reproduce the volume of the prostate. Following this, the area to be targeted will be selected in graded fashion from the anterior to posterior of the prostate. Once planning of ROI (region of interest) is complete, the HIFU treatment may begin. Quadrant or hemi ablation will be performed based on the size and complexity of the tumor. The distal margin of the ablation will be kept at least 4 mm away from the external sphincter. The rectal temperature and its distance from the probe will be carefully monitored throughout the procedure.
Treatment groups
276 Participants
are divided into 2 treatment groupsGroup A: Transvesical Single Port Robotic Partial ProstatectomyActive comparator 1 intervention
Group B: High-intensity focused ultrasound (HIFU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence free survival Recurrence free survival
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
Time frame
1 year after treatment2
Recurrence free survival
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
Time frame
2 years after treatment3
Recurrence free survival
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
Time frame
3 years after treatmentSecondary outcomes
1
Operative time
Minutes from incision to closing during surgery (median)
Time frame
At initial treatment (postoperative day 0)2
Postoperative Complications
Clavien-dindo classification number (1-5), number (percent)
Time frame
Within 3 months after treatment.3
Analgesic requirment
Units of oral morphine equivalent dosing (mg), median
Time frame
Once at first follow up (up to 7 days after initial treatment)4
Postoperative hospital stay
Time that patient is observed in the hospital after surgery, in hours (median)
Time frame
Up to 1 day after initial treatmentSponsors and contacts
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Source ClinicalTrials.gov