Clinical trial NCT03263780: High Resolution PET-MRI Before Prostate Cancer HIFU
Official title: High-Resolution, 18F-fluciclovine PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Diagnostic imaging
High-Intensity Focused Ultrasound
HIFU
18F-Fluciclovine
high resolution diffusion-weighted imaging
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Blue Earth Diagnostics
First posted: 2017-08-28
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
timeFrame: At time of post-imaging biopsy
measure: Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
timeFrame: At time of post-imaging biopsy
Secondary outcomes:
measure: Negative Biopsy Rate (Number of Participants With Negative Biopsy)
timeFrame: 6 months following standard HIFU therapy
measure: Rate of High Grade Cancer (Number of Patients With High Grade Cancer)
timeFrame: 6 months following standard HIFU therapy
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Timothy Daskivich, MD
role: PRINCIPAL_INVESTIGATOR
References: