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Compares treatment options for Prostate Adenocarcinoma
Official title Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound
ClinicalTrials.gov ID: NCT05610852
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older, men only
You may be able to join if
- people must have histologically or cytologically: Biopsy-confirmed prostate cancer, stage T1a, T2a, T2b, or T2c prostate cancer using MRI staging...
- 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...
- 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...
- 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...
You likely can't join if
- 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...
See the full eligibility criteria
- people 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...
- 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...
- 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 assigned by chance 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.
- people must have the ability to understand and the willingness to sign a written informed consent document.
- 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...
- Prostate size larger than 80 grams.
- people with prostatic Calcification (\>0.5 cc) close to the area to be treated.
- people with extraprostatic extension or cribriform pattern on biopsy.
- Subjectes with sexual dysfunction defined as SHIM score \< 17
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.