NCT05610852 · Case Comprehensive Cancer Center
Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound
What this study is 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.
View original scientific description
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.
Interventions
PROCEDURE
Transvesical Single Port Robotic Partial Prostatectomy
A 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.
PROCEDURE
High-intensity focused ultrasound (HIFU)
Three 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.
Primary outcome measures
Recurrence free survival Recurrence free survival
Time frame: 1 year after treatment
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
Recurrence free survival
Time frame: 2 years after treatment
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
Recurrence free survival
Time frame: 3 years after treatment
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Cleveland, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations