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

Primary Purpose

Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

18F-PSMA

About this trial

This is an interventional other trial for Prostatic Neoplasms focused on measuring Diagnostic imaging, High-Intensity Focused Ultrasound, HIFU, 18F-PSMA, high resolution diffusion-weighted imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ARM 1 (HIFU) - 18F-PSMA

ARM 2 (RP) - 18F-PSMA

Arm Description

10 mCi ±20% F18-PSMA injection

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Secondary Endpoint (HIFU):

Negative biopsy rate on standard 12-core biopsy 6 months following HIFU therapy.

Secondary Endpoint (Prostatectomy):

Specificity of hrMRI, F18-PSMA PET and mpMRI for detecting all tumors and metastasis at 6 months follow up.

Full Information

NCT ID

NCT04461509

First Posted

July 3, 2020

Last Updated

June 12, 2023

Sponsor

Alessandro D'Agnolo

Collaborators

Progenics Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04461509

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 6, 2021 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Alessandro D'Agnolo

Collaborators

Progenics Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ARM 1 (HIFU) - 18F-PSMA

Arm Type

Experimental

Arm Description

10 mCi ±20% F18-PSMA injection

Arm Title

ARM 2 (RP) - 18F-PSMA

Arm Type

Experimental

Arm Description

10 mCi ±20% F18-PSMA injection

Intervention Type

Drug

Intervention Name(s)

18F-PSMA

Other Intervention Name(s)

18F-DCFPyL Injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Primary Endpoint (HIFU):

Description

Time Frame

At time of post-imaging biopsy, 6 months following standard HIFU therapy

Title

Primary Endpoint (Prostatectomy):

Description

Time Frame

preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery

Secondary Outcome Measure Information:

Title

Secondary Endpoint (HIFU):

Description

Negative biopsy rate on standard 12-core biopsy 6 months following HIFU therapy.

Time Frame

6 months following standard HIFU therapy

Title

Secondary Endpoint (Prostatectomy):

Description

Specificity of hrMRI, F18-PSMA PET and mpMRI for detecting all tumors and metastasis at 6 months follow up.

Time Frame

6 months following standard HIFU therapy

Other Pre-specified Outcome Measures:

Title

Exploratory Endpoint:

Description

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.

Time Frame

After study completion, an average of 6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jenny Park, MPH

Phone

310-423-8762

Jenny.park@cshs.org

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Sarmiento

Phone

310-423-4295

Laura.sarmiento@cshs.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alessandro D'Agnolo, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alessandro D'Agnolo, MD

Phone

310-423-4682

Alessandro.Dagnolo@cshs.org

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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