High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04461509
• Other study ID #: STUDY00000832
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 6, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 61
• Est. completion date: September 30, 2024
• Est. primary completion date: February 6, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Genital Diseases, Male
• Genital Neoplasms, Male
• Neoplasms
• Neoplasms by Site
• Prostatic Disease
• Prostatic Diseases
• Prostatic Neoplasms
• Urogenital Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Alessandro D'Agnolo	Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Endpoint:	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
Primary	Primary Endpoint (HIFU):	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	Primary Endpoint (Prostatectomy):	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	Secondary Endpoint (HIFU):	Negative biopsy rate on standard 12-core biopsy 6 months following HIFU therapy.	6 months following standard HIFU therapy
Secondary	Secondary Endpoint (Prostatectomy):	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