Investigating MRI-guided thermal therapy for prostate cancer

Magnetic Resonance Image (MRI) Guided High Energy Ultrasound for Focal Prostate Cancer Ablation

This study is testing a new way to treat localized prostate cancer using MRI-guided ultrasound to see if it can safely remove tumors with fewer side effects for patients with low volume and low grade cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Drugs / interventions: radiation
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT04808427 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the feasibility and tolerability of using Transurethral UltraSound Ablation (TULSA) combined with MRI guidance to treat localized prostate cancer. Participants will undergo a series of screenings, including medical history, physical exams, and MRI scans, to determine their eligibility for the treatment. The focus is on patients with low volume and low grade prostate cancer, aiming to minimize side effects typically associated with more invasive treatments. The study will assess the effectiveness of this approach in achieving successful ablation of visible tumors.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adults aged 18 and older with localized prostate cancer that is visible on MRI and amenable to thermal ablation.

Not a fit: Patients with high-grade prostate cancer or those whose tumors are not visible on MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive option for patients with localized prostate cancer, reducing the risk of side effects like urinary incontinence and erectile dysfunction.

How similar studies have performed: Previous studies have shown varying success with thermal ablation methods, but this specific approach using MRI guidance and TULSA is relatively novel.

Eligibility criteria

* INCLUSION CRITERIA:

Subjects must have prostate cancer amenable for ultrasound ablation defined as:

* diagnosed by transrectal ultrasound-guided prostate biopsy via standard 12 core biopsy and targeted biopsy of any MRI-visible or tracked lesions; pathological diagnosis must be confirmed by Laboratory of Pathology, NCI;
* Gleason Score \<= 7;
* MRI-visible or MRI-tracked prostate cancer. This includes prostate cancer found on targeted biopsy of MRI-visible or MRI-tracked lesion. Histologically positive standard biopsy cores of Grade Group \>= 2 prostate cancer must be from an area overlying or within 1cm of an MRI-visible or tracked lesion(s) and reviewed by NCI urologic pathologist. (Left / Right, Base, Mid-Gland, Apex). Systematic and targeted cores of Grade Group 1 prostate cancer outside of proposed ablation zone do not affect inclusion status, as these can be observed by conventional guideline management.
* organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI. Note: Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI are eligible.
* PSA \< 20 ng/ml or PSA \>20 with a PSA density \<0.15.
* Adults (\>= 18 years of age)
* Participants must have adequate organ and marrow function as defined below:

Platelets \>= 50,000/mcL

Hemoglobin \>= 8 g/dL

Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\* \>= 30 mL/min/1.73 m\^2

GFR=glomerular filtration rate; ULN=upper limit of normal.

\*Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.

* Subjects must be able to understand and willing to sign a written informed consent document.
* Subjects must be co-enrolled to NCI protocol 16-C-0010 "Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue."

EXCLUSION CRITERIA:

* Targeted lesion ablation length from apex to base of \>5 cm or lesion extending \>3 cm from the urethra.
* Target ablation volume greater than 100 ml.
* Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target.
* Participants are unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc.)
* Acute urinary tract infection
* Lower urinary tract symptoms defined by an IPSS \> 20
* Participants with uncontrolled coagulopathies (including liver dysfunction, or untreated hereditary coagulopathies which have a standard of care treatment) per surgeon discretion based on bleeding risk.
* 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 situation (within time frame) that would limit compliance with study requirements.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Peter A Pinto, M.D. — National Cancer Institute (NCI)
• Study coordinator: Karen K Holcomb

Conditions: Prostate Cancer, TULSA, Thermal Therapy System, PSA, Gleason Score