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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Neoplasms; Genital Diseases, Male; Prostatic Disease
• Intervention / Treatment: Drug: 18F-PSMA

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: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: 18F-DCFPyL Injection
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: 18F-DCFPyL Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint (HIFU): Identification of New Cancers	The grade of the cancer is assessed by biopsy prior to HIFU. Systematic and targeted prostate biopsies assess presence or absence of cancer in each zone of the prostate, including both systematic and targeted zones. Each zone with cancer is graded using the Gleason score (range 6-10, with higher scores associated with more aggressive disease). The primary outcome is for detection of any additional cancer with advanced imaging techniques of hrMRI or PSMA-PET MRI over standard multiparametric MRI. Any cancer is defined as "Gleason 6 or higher." We also did an exploratory analysis looking at detection of additional cancers with Gleason scores of 7 or higher.	At time of pre-HIFU biopsy
Primary Endpoint (HIFU):	The primary endpoint of the Phase II study is to assess the number of participants with biopsy-proven cancers that mpMRI would have missed compared with hrMRI and/or F18-PSMA PET.	preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Secondary Endpoint (HIFU):	Negative biopsy rate on systematic and targeted biopsy 6 months following HIFU therapy. Data presented are from both systematic + targeted biopsy as a single unit. For example, a positive biopsy from a given area of the prostate could have come from either systematic or targeted cores.	6 months following standard HIFU therapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alessandro D'Agnolo
• Collaborators: Progenics Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Alessandro D'Agnolo, MD, Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• Basso Dias A, Ghai S, Ortega C, Mirshahvalad SA, Perlis N, Berlin A, Avery L, Veit-Haibach P, van der Kwast T, Metser U. Impact of 18F-DCFPyL PET/MRI in Selecting Men With Low-/Intermediate-Risk Prostate Cancer for Focal Ablative Therapies. Clin Nucl Med. 2023 Oct 1;48(10):e462-e467. doi: 10.1097/RLU.0000000000004819.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): September 3, 2024
• Study Completion (Actual): September 3, 2024

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Diagnostic imaging; HIFU; High-Intensity Focused Ultrasound; 18F-PSMA; high resolution diffusion-weighted imaging
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms; Prostatic Neoplasms; Urogenital Neoplasms; Genital Neoplasms, Male; Neoplasms by Site; Prostatic Diseases; Genital Diseases, Male; 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid
• Other Study ID Numbers: STUDY00000832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No