High Resolution PET-MRI Before Prostate Cancer HIFU

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.

Key facts

Study ID

NCT03263780

Run by

Timothy J. Daskivich

People needed

21

Starts

2017-12-07

Expected to finish

2020-01-08

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Prostate biopsy consisting of ≥ 10 tissue cores sampled
• PSA </=20 ng/mL
• cT1-cT2c
• Either overall gleason score >/= 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with >/= half of systematic biopsy cores positive and >/= 50% of core involvement in at least one core
• Patient considering focal HIFU therapy

You may not qualify if…

• Previous local therapy for prostate cancer
• Inability to receive PET tracer
• Inability to receive MRI
• Suggestion of extracapsular extension or seminal vesicle invasion on imaging
• Estimated creatinine clearance <45 mL/min (Cockcroft-Gault equation)
• Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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