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Single-Center Study Of Single-Port Transvesical Partial Prostatectomy Versus

Primary Purpose

Prostate Adenocarcinoma, Prostate Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transvesical Single Port Robotic Partial Prostatectomy
High-intensity focused ultrasound (HIFU)
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring High Intensity Focused Ultrasound (HIFU), Single-Port Transvesical Partial Prostatectomy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Transvesical Single Port Robotic Partial Prostatectomy

    High-intensity focused ultrasound (HIFU)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Recurrence free survival Recurrence free survival
    Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
    Recurrence free survival
    Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
    Recurrence free survival
    Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy

    Secondary Outcome Measures

    Operative time
    Minutes from incision to closing during surgery (median)
    Postoperative Complications
    Clavien-dindo classification number (1-5), number (percent)
    Analgesic requirment
    Units of oral morphine equivalent dosing (mg), median
    Postoperative hospital stay
    Time that patient is observed in the hospital after surgery, in hours (median)
    Foley catheter duration
    Time at which the foley catheter is removed after treatment, in days (median)
    Time to urinary continence
    Time at which the patient becomes continent in days (median)
    Urinary continence
    Continence defined as using 1 pad for security or less for stress urinary incontince, recorded as yes or no (percent)
    Erectile dysfunction
    Assessed using scores from a validated survey (IIEF-5). Recorded as the the score from 5 (impotent) to 25 (no impotence), median.
    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)
    Secondary interventions
    Time point at which the patient undergoes treatment for prostate cancer recurrence

    Full Information

    First Posted
    October 31, 2022
    Last Updated
    July 21, 2023
    Sponsor
    Case Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05610852
    Brief Title
    Single-Center Study Of Single-Port Transvesical Partial Prostatectomy Versus
    Official Title
    Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2026 (Anticipated)
    Study Completion Date
    July 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Case Comprehensive Cancer Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief 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. 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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Adenocarcinoma, Prostate Cancer
    Keywords
    High Intensity Focused Ultrasound (HIFU), Single-Port Transvesical Partial Prostatectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    276 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Transvesical Single Port Robotic Partial Prostatectomy
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    High-intensity focused ultrasound (HIFU)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Transvesical Single Port Robotic Partial Prostatectomy
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    High-intensity focused ultrasound (HIFU)
    Intervention Description
    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 Measure Information:
    Title
    Recurrence free survival Recurrence free survival
    Description
    Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
    Time Frame
    1 year after treatment
    Title
    Recurrence free survival
    Description
    Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
    Time Frame
    2 years after treatment
    Title
    Recurrence free survival
    Description
    Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
    Time Frame
    3 years after treatment
    Secondary Outcome Measure Information:
    Title
    Operative time
    Description
    Minutes from incision to closing during surgery (median)
    Time Frame
    At initial treatment (postoperative day 0)
    Title
    Postoperative Complications
    Description
    Clavien-dindo classification number (1-5), number (percent)
    Time Frame
    Within 3 months after treatment.
    Title
    Analgesic requirment
    Description
    Units of oral morphine equivalent dosing (mg), median
    Time Frame
    Once at first follow up (up to 7 days after initial treatment)
    Title
    Postoperative hospital stay
    Description
    Time that patient is observed in the hospital after surgery, in hours (median)
    Time Frame
    Up to 1 day after initial treatment
    Title
    Foley catheter duration
    Description
    Time at which the foley catheter is removed after treatment, in days (median)
    Time Frame
    Up to 7 days after initial treatment
    Title
    Time to urinary continence
    Description
    Time at which the patient becomes continent in days (median)
    Time Frame
    Assessed at each visit for up to 1 year after treatment
    Title
    Urinary continence
    Description
    Continence defined as using 1 pad for security or less for stress urinary incontince, recorded as yes or no (percent)
    Time Frame
    Assessed at each visit for up to 1 year after treatment
    Title
    Erectile dysfunction
    Description
    Assessed using scores from a validated survey (IIEF-5). Recorded as the the score from 5 (impotent) to 25 (no impotence), median.
    Time Frame
    Assessed at each visit for up to 3 years
    Title
    Biochemical recurrence
    Description
    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)
    Time Frame
    Assessed at each visit for up to 3 years
    Title
    Secondary interventions
    Description
    Time point at which the patient undergoes treatment for prostate cancer recurrence
    Time Frame
    Assessed at the time of clinic visits up to 3 years after treatment.

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jihad Kaouk, MD
    Phone
    216-444-2976
    Email
    kaoukj@ccf.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jihad Kaouk, MD
    Organizational Affiliation
    Glickman Urological & Kidney Institute: Professor of Urology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Single-Center Study Of Single-Port Transvesical Partial Prostatectomy Versus

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