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
Qualifiers
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
Treatments tested in this trial
- Transvesical Single Port Robotic Partial Prostatectomy
- High-intensity focused ultrasound (HIFU)
Treatment groups
276 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov