High Resolution PET-MRI Before Prostate Cancer HIFU

Timothy J. Daskivich

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: 18F-Fluciclovine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03263780

IIT2016-19-DASKIVICH-18F

Details and patient eligibility

About

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.

Full description

This is a prospective trial to evaluate the effectiveness of 18F-fluciclovine PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.

Participants with clinically localized, unilateral high grade prostate cancer (Gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having unrecognized high grade prostate cancer (overall Gleason score 6 with > half of systematic biopsy cores positive and > 50% of core involvement in at least one core), interested in HIFU would receive both a standard mpMRI and 18F-fluciclovine PET-hrMRI.

Participants would then undergo a mapping biopsy using a standard sextant template plus MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.

Enrollment: 21 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

18F-Fluciclovine

Experimental group

Description:

10mCi +/-20% 18F-fluciclovine injection

Treatment:

Drug: 18F-Fluciclovine