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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2024-09-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ARM 1 (HIFU) - 18F-PSMA

10 mCi ±20% F18-PSMA injection

Group Type EXPERIMENTAL

18F-PSMA

Intervention Type 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

ARM 2 (RP) - 18F-PSMA

10 mCi ±20% F18-PSMA injection

Group Type EXPERIMENTAL

18F-PSMA

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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18F-DCFPyL Injection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No