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“The ability to gather actionable information from PSMA PET scans is important for physicians to make informed decisions about patient management for men with prostate cancer,” says Eugene Teoh, MBBS, MRCP, FRCR, DPhil.

The BLA submission is supported by findings from the phase 3 ZIRCON trial, which demonstrated high specificity and sensitivity of TLX250-CDx for PET/CT imaging of ccRCC.

Patients with high-risk disease were shown to have a significantly higher mean value of SUVmax compared with patients with low-risk disease (23.5 ± 13.2 vs 10.6 ± 5.4; P < 0.05).

"This announcement is an important step in increasing the awareness and accessibility of OnQ Prostate beyond its earliest adopters, so that more physicians and patients can benefit from this technology," says Brittany Hunt.

“If approved by the FDA, this new product will have a significant impact on prostate cancer patients, physicians, and their caregivers by helping to eliminate the inequity of access to PSMA-PET agents, and increase the ability to accurately diagnose cancer early, reducing the cost of care, and increasing the probability of patients’ survival," says Mike Crosby.

The phase 2/3 AlphaBreak trial is evaluating the safety and efficacy of FPI-2265 in patients with mCRPC who have been previously treated with 177Lu-PSMA radiotherapy.

"This was a very special moment, delivering the news to this patient that his cancer is now undetectable following the treatment with 2 doses of 8 GBq of 67Cu-SAR-bisPSMA," says Luke Nordquist, MD, FACP.

A late phase 3 trial evaluating the agent is underway at several clinics in Europe.

The first patient was treated with TLX250-CDx at the Olivia Newton-John Cancer Wellness Centre at Austin Health in Melbourne, Australia,

Both the SOLAR-STAGE and SOLAR-RECUR trials are currently enrolling patients with prostate cancer in the US, with additional sites expected to open in Europe later this year.

"The advance of PSMA imaging has put an emphasis on multidisciplinary care," says Kenneth J. Pienta, MD.

“In the future, this imaging technique can help to streamline the drug development process, driving conviction in the agents we bring to larger scale trials," says Stephen Rose, PhD.

"In terms of the minimal overlapping toxicity, our non-clinical data from the xenograft model showed minimal toxicity with the combination," says Caroline Foxton, PhD.

Since piflufolastat (18F) was granted marketing authorization by the European Commission in July 2023, doses have been commercially sold in Greece, Italy, and the Netherlands.

The expanded label for 177Lu-PSMA-617 would include patients with mCRPC in the pre-taxane-based chemotherapy setting.

Convergent plans to conduct phase 2 clinical trials of 225Ac-J591 in prostate cancer in 2024, with a registrational program set to begin in 2025.

With the dosing of the first patient in Italy, Telix’s expanded access program for TLX250-CDx in ccRCC now includes 3 active countries, including the Netherlands and the US.

Among all patients treated in the study to date, 60% demonstrated a PSA reduction of greater than 35%, and 27% demonstrated a PSA reduction of greater than 80%.

The therapy is currently being manufactured in Italy at Curium facilities in Milan.

In this interview, Robert Reiter, MD, MBA, discusses the accuracy of PSMA-PET scans, false negative and false positive rates, and how treatment with ADT affects PSMA uptake.

Daniel Spratt, MD, highlights the evolving paradigm of PET-based imaging agents in prostate cancer, with a focus on the impact of PSMA-PET imaging.

In total, the phase 1/2 PRESERVE-006 trial is expected to enroll 144 patients across 20 clinical trial sites in the US.

All patients treated with 177Lu-rhPSMA-10.1 had reductions in their PSA levels from the start of treatment and none experienced a serious treatment-related adverse event.

In patients where SOC imaging was unable to detect any lesions, 64Cu-SAR-bisPSMA was able to identify lesions in approximately 60% of patients on same-day imaging and up to 80% on next-day imaging.

“Treatment based on visualization of 18F-flotufolastat–avid lesions may facilitate optimal targeting of recurrence sites and avoid futile salvage therapy,” said Przemyslaw Twardowski, MD.

The conference explored the current and future use of PSMA-PET imaging and PSMA radioligand therapy to improve the clinical care of patients with prostate cancer.

PSMA uptake in the prostatic midline is often linked with urine stagnation in the prostatic urethra and can lead to misinterpretation on PSMA-PET/CT,” the authors wrote. “Using post-void MRIs may help reduce false positives.”

“99mTc‐PSMA-SPECT/CT is useful in the primary diagnosis of prostate cancer,” the authors wrote.

“This data supports the clinical benefit of 177Lu-PSMA-617 in real-world clinical practice,” the researchers wrote in their poster conclusion.

“Prostatic extracellular vesicles represent a promising biomarker with the potential for reduction of false positive rate in men with elevated PSA following mpMRI,” the authors wrote.