- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04461509
High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy
High-Resolution, 18F-PSMA PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy or Radical Prostatectomy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jenny Park, MPH
- Phone Number: 310-423-8762
- Email: Jenny.park@cshs.org
Study Contact Backup
- Name: Laura Sarmiento
- Phone Number: 310-423-4295
- Email: Laura.sarmiento@cshs.org
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ARM 1 (HIFU) - 18F-PSMA
10 mCi ±20% F18-PSMA injection
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Endpoint (HIFU):
Time Frame: 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.
|
At time of post-imaging biopsy, 6 months following standard HIFU therapy
|
Primary Endpoint (Prostatectomy):
Time Frame: 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.
|
preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Endpoint (HIFU):
Time Frame: 6 months following standard HIFU therapy
|
Negative biopsy rate on standard 12-core biopsy 6 months following HIFU therapy.
|
6 months following standard HIFU therapy
|
Secondary Endpoint (Prostatectomy):
Time Frame: 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.
|
6 months following standard HIFU therapy
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory Endpoint:
Time Frame: 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.
|
After study completion, an average of 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alessandro D'Agnolo, MD, Cedars-Sinai Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000832
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasms
-
European Association for Endoscopic SurgeryWithdrawn
-
Moscow Clinical Scientific CenterRecruitingCecal Neoplasms | Colonic Neoplasms MalignantRussian Federation
-
Chang Gung Memorial HospitalNational Science and Technology CouncilNot yet recruiting
-
Instituto Nacional de Cancer, BrazilCompletedHead Neck NeoplasmsBrazil
-
Sun Yat-sen UniversityPeking Union Medical College Hospital; RenJi Hospital; Shengjing Hospital; First... and other collaboratorsRecruitingSurgery | Rectal Neoplasms MalignantChina
-
NovartisBayerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic NeoplasmsBelgium, Germany, Italy, United States, Taiwan, Switzerland, Spain, Canada, Slovakia, United Kingdom, New Zealand, Australia, Portugal, Brazil, Hungary, Czechia, France, Netherlands, Sweden
-
Attikon HospitalCompleted
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedColorectal Neoplasms | Rectal Neoplasms | Colonic Neoplasms
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
John M. BuattiNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedUterine Cervical Neoplasms | Prostatic Neoplasms | Rectal Neoplasms | Endometrial Neoplasms | Anus NeoplasmsUnited States
Clinical Trials on 18F-PSMA
-
University of AlbertaActive, not recruiting
-
University Hospital, GhentCompleted
-
Primo Biotechnology Co., LtdABX advanced biochemical compounds GmbHRecruitingProstate Cancer | Prostate NeoplasmTaiwan
-
University Hospital Inselspital, BerneActive, not recruiting
-
University of Wisconsin, MadisonTerminated
-
Irene BurgerCompletedProstate CancerSwitzerland
-
IRCCS San RaffaeleNot yet recruiting
-
University of AlbertaRecruiting
-
Wuerzburg University HospitalRecruitingGastrointestinal CancerGermany