Clinical trial NCT04461509: High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy
Official title: High-Resolution, 18F-PSMA PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy or Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Disease
Keywords: Diagnostic imaging
High-Intensity Focused Ultrasound
HIFU
18F-PSMA
high resolution diffusion-weighted imaging
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2020-07-08
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are identified by investigator and enrolled in Arm 1 (HIFU) or Arm 2 (RP)
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-PSMA 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-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.

Eligibility criteria: Inclusion Criteria:

1. Biopsy consisting of ≥ 10 tissue cores sampled
2. PSA \<20 ng/mL (for HIFU arm only)
3. cT1-cT2c
4. 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)
5. Patient considering focal HIFU therapy or robotic radical prostatectomy

Exclusion Criteria:

1. Previous local therapy for prostate cancer
2. Inability to receive PET tracer
3. Inability to receive MRI
4. Estimated glomerular filtration rate (GFR) \<15 mL/min/1.73 m2
5. 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: Primary Endpoint (HIFU): Identification of New Cancers
timeFrame: At time of pre-HIFU biopsy
measure: Primary Endpoint (Prostatectomy):
timeFrame: preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery
Secondary outcomes:
measure: Secondary Endpoint (HIFU):
timeFrame: 6 months following standard HIFU therapy
measure: Secondary Endpoint (Prostatectomy):
timeFrame: 6 months following standard HIFU therapy
Other outcomes:
measure: Exploratory Endpoint:
timeFrame: After study completion, an average of 6 months
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Alessandro D'Agnolo, MD
role: PRINCIPAL_INVESTIGATOR
References: