High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy
Study Details
Study Description
Brief Summary
This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-PSMA PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
This is a prospective trial to evaluate the effectiveness of 18F-PSMA 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-PSMA 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ARM 1 (HIFU) - 18F-PSMA 10 mCi ±20% F18-PSMA injection |
Drug: 18F-PSMA
Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-PSMA)
Other Names:
18F-DCFPyL Injection prostate-cancer-specific radiotracer
Other Names:
|
Experimental: ARM 2 (RP) - 18F-PSMA 10 mCi ±20% F18-PSMA injection |
Drug: 18F-PSMA
Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-PSMA)
Other Names:
18F-DCFPyL Injection prostate-cancer-specific radiotracer
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Primary Endpoint (HIFU): [At time of post-imaging biopsy, 6 months following standard HIFU therapy]
Number of additional biopsy-proven cancers that novel imaging modalities of hrMRI and/or F18-PSMA PET would detect when compared to reference standard imaging of mpMRI in patients undergoing HIFU procedure.
- Primary Endpoint (Prostatectomy): [preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery]
To determine the sensitivity in detection of prostatic carcinoma of novel imaging modalities of hrMRI and/or F18-PSMA PET compared to reference standard mpMRI in patients scheduled to undergo radical prostatectomy.
Secondary Outcome Measures
- Secondary Endpoint (HIFU): [6 months following standard HIFU therapy]
Negative biopsy rate on standard 12-core biopsy 6 months following HIFU therapy.
- Secondary Endpoint (Prostatectomy): [6 months following standard HIFU therapy]
Specificity of hrMRI, F18-PSMA PET and mpMRI for detecting all tumors and metastasis at 6 months follow up.
Other Outcome Measures
- Exploratory Endpoint: [After study completion, an average of 6 months]
RNAseq transcriptome analysis of lesions that are positive on mapping biopsy. Sensitivity and specificity of PET-hrMRI for detecting all tumors detected on prostatectomy pathology.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Biopsy consisting of ≥ 10 tissue cores sampled
-
PSA <20 ng/mL (for HIFU arm only)
-
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 (for HIFU arm only)
-
Patient considering focal HIFU therapy or robotic radical prostatectomy
Exclusion Criteria:
-
Previous local therapy for prostate cancer
-
Inability to receive PET tracer
-
Inability to receive MRI
-
Estimated glomerular filtration rate (GFR) <15 mL/min/1.73 m2
-
Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
Sponsors and Collaborators
- Alessandro D'Agnolo
- Progenics Pharmaceuticals, Inc.
Investigators
- Principal Investigator: Alessandro D'Agnolo, MD, Cedars-Sinai Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00000832