68Ga-PSMA-11 PET/MRI for Selecting Men With Prostate Cancer for Focal Therapy

Summary

Focal therapy is a minimally invasive treatment option for some men with localized prostate cancer. Unlike surgery or radiation, focal therapy treats only the area of the prostate containing clinically significant cancer, with the goal of preserving urinary and sexual function. Successful focal therapy depends on accurately identifying all areas of clinically significant prostate cancer before treatment. Currently, multiparametric magnetic resonance imaging (MRI) is the standard imaging method used to determine whether a patient is a suitable candidate for focal therapy. However, MRI may miss some clinically significant cancers, which can lead to incomplete treatment.

This pilot study will evaluate whether 68Ga-PSMA-11 positron emission tomography/magnetic resonance imaging (PET/MRI) can improve the selection of men with localized prostate cancer for focal therapy compared with MRI alone. The study will enroll men with intermediate-risk prostate cancer who are already planning to undergo radical prostatectomy as part of their standard care.

Participants will receive a single injection of 68Ga-PSMA-11 followed by a PET/MRI scan before surgery. The PET/MRI findings and MRI findings will be reviewed separately and compared with the prostate tissue examined after surgery, which serves as the reference standard for determining the true location and extent of cancer.

The main question this study is trying to answer is whether 68Ga-PSMA-11 PET/MRI is more accurate than MRI alone in identifying men who are appropriate candidates for focal therapy. The study will also evaluate whether PET/MRI detects more clinically significant prostate cancer lesions than MRI alone.

Researchers hypothesize that 68Ga-PSMA-11 PET/MRI will improve the detection of clinically significant prostate cancer and more accurately identify patients who are suitable candidates for focal therapy, potentially reducing the risk of untreated cancer remaining in the prostate after treatment. If successful, the results of this pilot study will support the development of a larger clinical trial and may help improve future treatment planning for men with localized prostate cancer.

Conditions

• Prostate Cancer (Adenocarcinoma)
• Localized Prostate Cancer

Interventions

DRUG

Gallium Ga 68 Gozetotide (68Ga-PSMA-11)

Intervention Description: Gallium Ga 68 gozetotide (68Ga-PSMA-11) is a prostate-specific membrane antigen (PSMA)-targeted positron-emitting radiopharmaceutical used for PET imaging of prostate cancer. In this study, a single intravenous dose (111-259 MBq) will be administered before PET/MRI to evaluate its diagnostic performance for identifying clinically significant prostate cancer and improving selection of patients for focal therapy.

DIAGNOSTIC_TEST

Intervention Description: Integrated positron emission tomography/magnetic resonance imaging (PET/MRI) combines molecular imaging with high-resolution anatomical MRI to evaluate intraprostatic lesions

Gallium Ga 68 gozetotide (68Ga-PSMA-11) is a prostate-specific membrane antigen (PSMA)-targeted positron-emitting radiopharmaceutical approved for PET imaging of PSMA-expressing lesions in men with prostate cancer. In this study, it is administered as a single intravenous injection (111-259 MBq) before PET/MRI to evaluate its ability to improve detection of clinically significant intraprostatic disease and selection of patients for focal therapy compared with multiparametric MRI alone.

Sponsors & Collaborators

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Adriano Basso Dias, MD, MSc, Radiologist · University Health Network - Toronto General Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-07-31

Completion

2027-12-31

Countries

• Canada

Study Locations