Status:
RECRUITING
Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Background: The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy. Researchers want to improve on these methods. Ob...
Detailed Description
Background: Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years. Some prostate cancers prove to be small, low grade, and noninvasive and they a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04808427
Start Date
November 20 2023
End Date
September 1 2027
Last Update
November 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892