High Resolution PET-MRI Before Prostate Cancer HIFU

NCT ID: NCT03263780

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-07
• Study Completion Date: 2020-01-08

Brief Summary

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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

18F-Fluciclovine

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

Group Type: EXPERIMENTAL

18F-Fluciclovine

Intervention Type: DRUG

Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-Fluciclovine)

Interventions

18F-Fluciclovine

Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-Fluciclovine)

Intervention Type: DRUG

Other Intervention Names

Axumin; prostate-cancer-specific radiotracer

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Blue Earth Diagnostics

INDUSTRY

Sponsor Role: collaborator

Timothy J. Daskivich

OTHER

Sponsor Role: lead

Responsible Party

Timothy J. Daskivich

Staff Physician I, Division of Urology; Urologic Oncologist; Director, Health Services Research, Department of Surgery Cedars Sinai Medical Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Timothy Daskivich, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IIT2016-19-DASKIVICH-18F

Identifier Type: -

Identifier Source: org_study_id