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

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.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

* Ability to provide written informed consent.
* Age 18 years or older.
* Clinically significant prostate cancer (csPCa) with clinical stage ≤ T2c and planned radical prostatectomy.
* Serum prostate-specific antigen (PSA) ≤ 20 ng/mL.
* Clinically significant prostate cancer within an MRI-visible lesion, defined as - International Society of Urological Pathology (ISUP) Grade Group 2 or 3 (Gleason score 3+4 or 4+3) in any biopsy core.

Exclusion Criteria:

* Inability to lie still for the PET/MRI examination.
* Known contraindication or hypersensitivity to gallium Ga 68 gozetotide (68Ga-PSMA-11) or to the MRI gadolinium contrast agent, including any component of the formulation.