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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvesical Single Port Robotic Partial Prostatectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival Recurrence free survival | Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy | 1 year after treatment |
| Recurrence free survival | Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy | 2 years after treatment |
| Recurrence free survival | Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy | 3 years after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Minutes from incision to closing during surgery (median) | At initial treatment (postoperative day 0) |
| Postoperative Complications | Clavien-dindo classification number (1-5), number (percent) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihad Kaouk, MD | Contact | 216-444-2976 | kaoukj@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Jihad Kaouk, MD | Glickman Urological & Kidney Institute: Professor of Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| High-intensity focused ultrasound (HIFU) | Procedure | 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. |
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| Within 3 months after treatment. |
| Analgesic requirment | Units of oral morphine equivalent dosing (mg), median | 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) | Up to 1 day after initial treatment |
| Foley catheter duration | Time at which the foley catheter is removed after treatment, in days (median) | Up to 7 days after initial treatment |
| Time to urinary continence | Time at which the patient becomes continent in days (median) | 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) | 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. | 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) | Assessed at each visit for up to 3 years |
| Secondary interventions | Time point at which the patient undergoes treatment for prostate cancer recurrence | Assessed at the time of clinic visits up to 3 years after treatment. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |