Phase 2
Completed N=21
High Resolution PET-MRI Before Prostate Cancer HIFU
Source: ClinicalTrials.gov NCT03263780 ↗Enrolled (actual)
21
Serious AEs
7.7%
Results posted
Feb 2021
Primary outcomePrimary: 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
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.
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 | — |
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.
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. Informational only — not medical advice.