Prostate AdenocarcinomaNCT05610852
Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound
A study testing Transvesical Single Port Robotic Partial Prostatectomy and High-intensity focused ultrasound (HIFU) in people with Prostate Adenocarcinoma and Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Prostate Cancer
- What is being tested?
- Transvesical Single Port Robotic Partial Prostatectomy and High-intensity focused ultrasound (HIFU)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.)
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Jihad Kaouk, MD, kaoukj@ccf.org
About this study
Official title: Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)
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.
Read the 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)
- Conditions
- Prostate Adenocarcinoma, Prostate Cancer
- Being tested
- Transvesical Single Port Robotic Partial Prostatectomy, High-intensity focused ultrasound (HIFU)
- Keywords
- High Intensity Focused Ultrasound (HIFU), Single-Port Transvesical Partial Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvesical Single Port Robotic Partial ProstatectomyProcedure or surgery
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.
High-intensity focused ultrasound (HIFU)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Transvesical Single Port Robotic Partial Prostatectomy | Active comparator | 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. Receives: Procedure: Transvesical Single Port Robotic Partial Prostatectomy |
| High-intensity focused ultrasound (HIFU) | Active comparator | 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. Receives: Procedure: High-intensity focused ultrasound (HIFU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival Recurrence free survival
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
Measured: 1 year after treatment
Recurrence free survival
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
Measured: 2 years after treatment
Recurrence free survival
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
Measured: 3 years after treatment
Secondary outcomes (10)
Operative time
Minutes from incision to closing during surgery (median)
Measured: At initial treatment (postoperative day 0)
Postoperative Complications
Clavien-dindo classification number (1-5), number (percent)
Measured: Within 3 months after treatment.
Analgesic requirment
Units of oral morphine equivalent dosing (mg), median
Measured: Once at first follow up (up to 7 days after initial treatment)
Postoperative hospital stay
Time that patient is observed in the hospital after surgery, in hours (median)
Measured: Up to 1 day after initial treatment
Foley catheter duration
Time at which the foley catheter is removed after treatment, in days (median)
Measured: Up to 7 days after initial treatment
Time to urinary continence
Time at which the patient becomes continent in days (median)
Measured: Assessed at each visit for up to 1 year after treatment
Urinary continence
Continence defined as using 1 pad for security or less for stress urinary incontince, recorded as yes or no (percent)
Measured: Assessed at each visit for up to 1 year after treatment
Erectile dysfunction
Assessed using scores from a validated survey (IIEF-5). Recorded as the the score from 5 (impotent) to 25 (no impotence), median.
Measured: Assessed at each visit for up to 3 years
Biochemical recurrence
PSA recurrence defined as PSA nadir after treatment +1ng/ml within 12 months or PSA Nadir + 1.5ng/ml from 12-36 months. Recorded as yes or no (percent)
Measured: Assessed at each visit for up to 3 years
Secondary interventions
Time point at which the patient undergoes treatment for prostate cancer recurrence
Measured: Assessed at the time of clinic visits up to 3 years after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Jan 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jihad Kaouk, MD, Principal investigator, Glickman Urological & Kidney Institute: Professor of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610852
- Sponsor's protocol ID
- CASE10822
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)
- ClinicalTrials.gov ID
- NCT05610852
- Acronym / sponsor ID
- CASE10822
- Conditions
- Prostate Adenocarcinoma, Prostate Cancer
- Keywords
- High Intensity Focused Ultrasound (HIFU), Single-Port Transvesical Partial Prostatectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvesical Single Port Robotic Partial Prostatectomy | Active comparator | Procedure: Transvesical Single Port Robotic Partial ProstatectomyParticipants 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. |
| High-intensity focused ultrasound (HIFU) | Active comparator | Procedure: High-intensity focused ultrasound (HIFU)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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvesical Single Port Robotic Partial ProstatectomyA 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 or surgery | Transvesical Single Port Robotic Partial Prostatectomy |
| 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. | Procedure or surgery | High-intensity focused ultrasound (HIFU) |
Primary outcome
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
10 secondary outcomes
Operative time
Time frame: At initial treatment (postoperative day 0)
Postoperative Complications
Time frame: Within 3 months after treatment.
Analgesic requirment
Time frame: Once at first follow up (up to 7 days after initial treatment)
Postoperative hospital stay
Time frame: Up to 1 day after initial treatment
Foley catheter duration
Time frame: Up to 7 days after initial treatment
Time to urinary continence
Time frame: Assessed at each visit for up to 1 year after treatment
Urinary continence
Time frame: Assessed at each visit for up to 1 year after treatment
Erectile dysfunction
Time frame: Assessed at each visit for up to 3 years
Biochemical recurrence
Time frame: Assessed at each visit for up to 3 years
Secondary interventions
Time frame: Assessed at the time of clinic visits up to 3 years after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jihad Kaouk, MD principal investigator
Glickman Urological & Kidney Institute: Professor of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvesical Single Port Robotic Partial Prostatectomy and High-intensity focused ultrasound (HIFU) in people with Prostate Adenocarcinoma and Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihad Kaouk, MD (216-444-2976, kaoukj@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival Recurrence free survival (time frame: 1 year after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.