Next-Generation Imaging

According to Clarity Pharmaceuticals, the final results are intended to support an application to the FDA for approval of 64Cu-SAR-bisPSMA for imaging in patients with prostate cancer.

No dose-limiting toxicities were observed among the initial 3 patients in cohort 3, and no patients experienced adverse events related to 64Cu-SAR-bisPSMA.

The investigators observed no dose limiting toxicities or serious adverse events among all patients who received an ARX517 dose of 3.4 mg/kg, the highest dose tested in the trial.

“[18F]DCFPyL was assessed to be a suitable alternative to [68Ga]Ga-PSMA-11 in PCa diagnosis and staging due to its similar lesion uptake rate with no increase in benign uptakes," the authors wrote.

"Rather than receiving definitive radiation treatment for localized disease, these patients may have received treatment aimed at preventing the further spread of what was incorrectly identified as metastatic disease," says Thomas Hope, MD.

In a study published in The Lancet Oncology, UC San Francisco researchers conducted a phase 1 clinical trial assessing the combination of 177Lu-PSMA-617 and pembrolizumab in patients with metastatic castration-resistant prostate cancer.

The ProstACT GLOBAL study is investigating second-line TLX591 in combination with the current standard of care (SOC) vs SOC alone in patients with mCRPC who have progressed on a novel androgen axis drug.

The CPT code will be effective beginning July 1, 2024.

Researchers utilized the PI-QUAL scoring system to assess 355 mpMRI exams performed at 41 facilities in 18 countries.

At the time of the data cutoff, a maximum tolerated dose of 225Ac-J591 had not yet been reached.

“Preclinical and clinical findings thus far indicate that SAR-Bombesin holds significant potential for improving the diagnosis and treatment of prostate cancer,” said lead principal investigator Andrei Iagaru, MD.

Novartis is now equipped to provide 177Lu-PSMA-617 to patients within 2 weeks of diagnosis with advanced disease.

The primary end point of the phase 3 CLARIFY trial is the diagnostic capability of 64Cu-SAR-bisPSMA PET to identify regional node metastases.

Treatment with TLX591 resulted in a PSA reduction in nearly two-thirds of evaluable patients with PSMA-expressing metastatic castration-resistant prostate cancer.

US and Chinese companies are partnering to bring the PSMA-PET imaging agent flotufolastat F 18 to the armamentarium for patients with prostate cancer in China.

Overall, 43.3% of patients who had received a diagnosis of NMIBC had 1 or more additional lesions detected with APL-1706 plus BLC compared with WLC alone.

A recently published study compared bone scan with PSMA-PET for initial staging of prostate cancer.

"This is a whole other approach to treating patients with this cancer. If you think about that from the perspective of prostate cancer as a whole, this is a big deal," says Thomas A. Hope, MD.

"We had very high specificities. The specificities amongst the 3 readers ranged from 92% to 96%," says Phillip H. Kuo, MD, PhD, FACR.

"Overall, we found that there was a high detection rate in patients with PSA less than 1 ng/mL," says Ashesh B. Jani, MD, MSEE, FASTRO.

"Results showed that more than two-thirds of these men were found to have positive Posluma scans, with a quarter of them having extrapelvic lesions," says Ashesh B. Jani, MD, MSEE, FASTRO.

The phase 1/2 COMBAT study examining the novel theranostic 64Cu/67Cu-SAR-Bombesin.

"We'll have to obviously amend this document quickly as these drugs move earlier in the stage of disease," says Thomas A. Hope, MD.

"The reported bpMRI-based AI model detected the majority of locally recurrent prostate cancer after radiotherapy," the authors wrote in their study conclusion.

“Implementation of the most recent PI-RADS update did not improve the incongruence in prostate cancer grade assessment between MRI/ultrasound fusion targeted biopsy and surgery,” the authors wrote.

The reimbursement code for flotufolastat F 18 will be effective October 1, 2023.

An exclusive Urology Times survey measured US-based urologists’ uptake, access to, and indications for utilizing prostate-specific membrane antigen-targeting agents.

The radionuclide-drug conjugate 225Ac-J591 combines J591, a monoclonal antibody that recognizes PSMA, with actinium-225, a potent alpha emitter.

The incorporation of PSMA PET–imaging into a multivariate model enhanced the predictive accuracy for clinically significant prostate cancer in patients in the "PSA gray zone" of 4 to 10 ng/mL.

“We are pleased with the results we have generated in the BOP trial, which have shown that 64Cu SAR-Bombesin can detect lesions in men with biochemically recurrent prostate cancer that are negative or equivocal on PSMA PET,” said Louise Emmett, MBChB, FRACP, MD.