Phase 2 N=21 Other

High Resolution PET-MRI Before Prostate Cancer HIFU

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03263780 ↗

Enrolled (actual)

Serious AEs

7.7%

Results posted

Feb 2021

Primary outcome: Primary: 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. — 5; 1; 4; 1 Total biopsy-proven cancers (Gleason 6+) — p=0.056

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 18F-Fluciclovine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Timothy J. Daskivich
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	5; 1; 4; 1	0.056
PRIMARY 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.	1; 1; 1; 1	0.096
SECONDARY Negative Biopsy Rate (Number of Participants With Negative Biopsy)	11	—
SECONDARY Rate of High Grade Cancer (Number of Patients With High Grade Cancer)	1	—

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.

Eligibility Criteria

Inclusion Criteria

Prostate biopsy consisting of ≥ 10 tissue cores sampled
PSA /= 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03263780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.