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

Alessandro D'Agnolo

Status and phase: Completed; Phase 2

Conditions: Prostatic Disease; Neoplasms; Neoplasms by Site; Urogenital Neoplasms; Genital Neoplasms, Male; Prostatic Neoplasms; Genital Diseases, Male

Treatments: Drug: 18F-PSMA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04461509

STUDY00000832

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

ARM 1 (HIFU) - 18F-PSMA

Experimental group

Description:

10 mCi ±20% F18-PSMA injection

Treatment:

Drug: 18F-PSMA

ARM 2 (RP) - 18F-PSMA

Experimental group

Description:

10 mCi ±20% F18-PSMA injection

Treatment:

Drug: 18F-PSMA