RecruitingNot applicable

Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound

Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, MRI scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares robotic surgery that removes part of the prostate through one opening with high-intensity focused ultrasound (HIFU), which uses focused sound waves to treat cancer. It is for adults with low- to medium-risk prostate cancer that has not spread outside the prostate.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be older than 18.
  • A biopsy (small tissue sample) must confirm prostate cancer. MRI scans must show stage T1a, T2a, T2b, or T2c cancer.
  • An area on your MRI must have a PI-RADS score of 3 or higher, a rating of how likely it is to be cancer.
  • Your PSA blood test level must be 10 ng/mL or less.
  • Your Gleason score, which rates how cancer cells look, must be 3+4 or lower in every biopsy sample.
  • Your MRI must include the study's required scans and injected contrast dye. Your biopsy must include at least 12 general samples and at least 2 targeted samples from each MRI area rated 3 out of 5 or higher.
  • You must be expected to live more than 10 years.
  • You must be able to understand the study and willing to sign a consent form.

Who can't join

  • You have had major surgery or broken bones in the pelvis, surgery for hemorrhoids or anal tears, or have a heart pacemaker or metal implant.
  • You have had prostate cancer treatment, such as radiation, treatment aimed at one area, or hormone treatment.
  • You have an untreated blood-clotting problem or a history of latex allergy.
  • You have an active soft tissue or urine infection, a tube left in place to drain urine, or severe problems passing urine.
  • Surgery is too risky for you (an ASA risk score above 3), or another illness, past surgery, long-term opioid use, pain condition, or drug misuse could add risk or affect study results.
  • Your prostate weighs more than 80 grams, or you have calcium deposits larger than 0.5 cc near the treatment area.
  • Cancer has spread outside the prostate, or your biopsy shows a cribriform pattern (cancer cells with a sieve-like pattern). You have sexual function problems with a SHIM score below 17.
  • You have an uncontrolled illness, such as an infection, heart failure with symptoms, unstable chest pain, or an abnormal heartbeat. Mental health or social problems that could keep you from following study rules also exclude you.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

OH

  • Glickman Urological & Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center · Cleveland, OH 44195Jihad Kaouk, MD · Study contact · kaoukj@ccf.orgMore trials in Cleveland