Top 10 urologic imaging stories in 2023

There’s been an abundance of news surrounding imaging advances in urology over the last year. In honor of these breakthroughs, Urology Times® is highlighting our top content on urologic imaging from 2023.

FDA approves flotufolastat F 18 for PSMA-PET imaging in prostate cancer

In May 2023, the FDA approved flotufolastat F 18 (formerly 18F-rhPSMA-7.3; trade name, Posluma) for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level. The approval of the agent was supported by findings from the phase 3 SPOTLIGHT and LIGHTHOUSE trials. Read more on the approval here.

Guidelines published for 177Lu-PSMA-617 patient selection and use in prostate cancer

In September 2023, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) published recommendations for patient selection and appropriate use of the radionuclide therapy 177Lu-PSMA-617 (lutetium Lu 177 vipivotide tetraxetan; Pluvicto) in patients with prostate cancer. The SNMMI consensus statement was developed by an autonomous workgroup who developed their recommendations after reviewing 4 trials of 177Lu-PSMA-617: the phase 3 VISION trial, the phase 2 TheraP trial, and 2 prospective phase 2 trials that have been published. Read more on the guidelines here.

FDA approves new indication for Illuccix in metastatic prostate cancer

In March 2023, the FDA approved a supplemental New Drug Application for Illuccix, a radiopharmaceutical cold kit for the preparation of gallium-68 (68Ga) gozetotide (PSMA-11) injection. The PSMA-PET imaging product is now approved for the selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617; Pluvicto) PSMA-directed therapy is indicated. Read more here.

FDA classifies 177Lu-PSMA-617 drug shortage as resolved

After an ongoing drug shortage of 177Lu-PSMA-617, the FDA reclassified the shortage as resolved in October 2023. According to Novartis, the developer of the agent, the company is now equipped to provide 177Lu-PSMA-617 to patients within 2 weeks of diagnosis with advanced disease. Read more here.

FDA grants Fast Track Designation to ARX517 for metastatic castration-resistant prostate cancer

In July 2023, the FDA awarded Fast Track Designation to ARX517, an anti-prostate-specific membrane antigen (PSMA) antibody-drug conjugate investigational therapy indicated for use in patients with metastatic castration-resistant prostate cancer who experienced progression on an androgen receptor pathway inhibitor. ARX517 is a PSMA targeting agent composed of fully humanized anti-PSMA mAb linked to AS269, a microtubule inhibitor. Upon binding to PSMA on the surface of tumor cells and internalizing, the therapy releases pAF-AS269 to kill the cancer cells. Read more here.

FDA grants Fast Track designation to novel PSMA-targeted agent for mCRPC

In April of this year, the FDA granted Fast Track designation to the PSMA-targeted therapy 177Lu-PNT2002 for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). The novel agent is currently being explored in the phase 3 SPLASH trial. Read more here.

MRI-guided SBRT shows superiority to CT-guided SBRT in localized prostate cancer

Data from the phase 3 MIRAGE trial (NCT04384770) published in JAMA Oncology found magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) delivered with MRIdian was superior to computed tomography (CT)-guided SBRT in reducing acute genitourinary (GU) and gastrointestinal (GI) toxicity associated with localized prostate cancer. Findings showed that acute grade ≥2 GU toxicity rates were lower in the MRI group (24.4%) compared with in the CT group (43.4%). Acute grade ≥2 GI toxicity rates were also significantly lower in the MRI group vs the CT group at 0.0% vs 10.5%, respectively. Read more on the trial here.

PSMA uptake, access appear high for US-based urologists

An exclusive Urology Times survey measured US-based urologists’ uptake, access to, and indications for utilizing prostate-specific membrane antigen (PSMA)-targeting agents. Overall, results from 97 respondents showed high uptake and access to PSMA agents among US urologists.View full results from the survey here.

Multiparametric MRI demonstrates poor sensitivity in staging for prostate cancer

In a study published in Urologic Oncology, investigators showed that multiparametric magnetic resonance imaging (mpMRI) demonstrated poor sensitivity, positive predictive value, and negative predictive value in staging for prostate cancer.

The authors concluded, “Our results support the notion that mpMRI is an inadequate screening tool for locally advanced [prostate cancer] and should not be used as the sole means of presurgical [prostate cancer] staging. Rather, mpMRI findings should be carefully considered in addition to other important clinical factors which include individual patient history and clinical risk stratification and used in concert with other staging techniques.” Read more here.

Imaging agent 64Cu-SAR-bisPSMA effective in treatment-naive prostate cancer

Data from the phase 1 PROPELLER trial, presented at the 2023 Genitourinary Cancers Symposium, supported the safety and efficacy of the PSMA-PET imaging product 64Cu-SAR-bisPSMA in patients with treatment-naïve, histologically confirmed prostate cancer who are scheduled for radical prostatectomy.

According to the authors, “The resulting true positive rate and false negative rate were similar for 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 PET/CT.” Read more on the findings here.

You can view all of our content surrounding advances in urologic imaging here.