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

NCT04461509 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00000832
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Secondary Endpoint (HIFU):

  6 months following standard HIFU therapy

• Secondary Endpoint (Prostatectomy):

  6 months following standard HIFU therapy

Other Outcomes (1)

• Exploratory Endpoint:

  After study completion, an average of 6 months

Study Arms (2)

ARM 1 (HIFU) - 18F-PSMA

EXPERIMENTAL

10 mCi ±20% F18-PSMA injection

Drug: 18F-PSMA

ARM 2 (RP) - 18F-PSMA

EXPERIMENTAL

10 mCi ±20% F18-PSMA injection

Drug: 18F-PSMA

Interventions

18F-PSMA DRUG

Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer

Also known as: 18F-DCFPyL Injection

ARM 1 (HIFU) - 18F-PSMA; ARM 2 (RP) - 18F-PSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alessandro D'Agnolo: lead
• Progenics Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• 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.

  PMID: 37682613 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Results Point of Contact

• Title: Laura Sarmiento
• Organization: Cedars-Sinai Medical Center

Laura.sarmiento@cshs.org

310-423-4295

Study Officials

• Alessandro D'Agnolo, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Director Nuclear Medicine

Model Details: Patients are identified by investigator and enrolled in Arm 1 (HIFU) or Arm 2 (RP)

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 8, 2020
• Study Start: April 6, 2021
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: March 25, 2026
• Results First Posted: May 29, 2025

Record last verified: 2026-03

Locations

US (1)