Next-Generation Imaging

177Lu-PSMA-617 is FDA-approved for the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer.

The phase 2 STARLITE 2 trial is exploring the combination of the novel radiopharmaceutical TLX250 (177Lu-DOTA-girentuximab) and nivolumab in patients with advanced renal cell carcinoma.

The ongoing phase 1/2 COBRA trial is exploring the PSMA-PET imaging agent 64Cu SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy.

“Overall, there's no known advantage or disadvantage in a head-to-head trial of either one of these, but I do think they're complementary,” says Scott T. Tagawa, MD, when discussing radium-223 dichloride and lutetium Lu 177 vipivotide tetraxetan.

The novel radionuclide combination was safe and effective in men with progressive mCRPC who had previously received chemotherapy and novel androgen signaling inhibitors.

"Tools such as Illuccix PSMA-PET are incredibly valuable as we look for better ways to manage prostate cancer in men," said Michael Koch, MD.

"With the existing drugs, we are looking to make them better," said Scott T. Tagawa, MD.

Richard Wahl, MD, president of the Society of Nuclear Medicine and Molecular Imaging, highlights the approval of 177Lu-PSMA-617 (Lu 177 vipivotide tetraxetan) as the first targeted radioligand therapy for the treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer.

Phillip S. Low, PhD, led research that was critical to the development of targeted radioligand therapy 177Lu-PSMA-617 for the treatment of patients with prostate cancer.

The strategic partnership involves the PSMA-PET imaging agent piflufolastat F18 and the PSMA-targeted therapy lutetium Lu 177 vipivotide tetraxetan.

“What I'm quite hopeful for are PSMA-targeted alpha emitters,” says Scott T. Tagawa, MD, MS, FACP.

Eligible patients for the multicenter, nonrandomized, single-arm trial (NCT05249127) will have suspected recurrence of prostate cancer as determined by a rising prostate-specific antigen following definitive therapy.

Key outcome measures include disease status adjustment, disease staging adjustment, and change in clinical management plan.

The approval is based on findings from the phase 3 VISION trial.

“We look forward to the optimization of these drugs,” says Scott T. Tagawa, MD, MS, FACP.

Over 90% of patients had a ≥50% reduction in their PSA level when receiving the PSMA-targeted therapy 225Ac-PSMA-617.

In this interview, Brian D. Gonzalez, PhD, shares results that were presented at the 2022 ASCO Genitourinary Cancers Symposium from the study, "Improvements in symptoms related to bone metastasis in recipients of Lutetium-177 PSMA-617 for prostate cancer."

“I think that we keep getting better and better tools…[and] I think understanding how to utilize these tools will be a challenge in the future,” says David M. Schuster, MD, FACR.

Lead author David M. Schuster, MD, FACR, assessed the detection rate of the novel theranostic PET ligand in a population of almost 400 men and found that the data supported clinical utility of 18F-rhPSMA-7.3 PET in managing men with recurrent prostate cancer across a wide range of prostate-specific antigen levels.

“Those that did complete the surveys generally reported average improvements in bone-metastasis-related pain and ability to function despite that pain,” says Brian D. Gonzalez, PhD.

“We call this a ‘disruptive innovation,’” says Leonard S. Marks, MD.

The phase 1/2 COBRA trial is exploring the novel PSMA-PET imaging agent 64Cu-SAR-bisPSMA in patients with biochemical recurrence.

We've never had an imaging agent like this before,” says Leonard S. Marks, MD.

In a recent interview, Hossein Jadvar, MD, PhD, discussed what the appropriate use criteria consist of for prostate-specific membrane antigen (PSMA)-PET imaging, and why these criteria are vital in ensuring the individualized care of patients.

“This is an attempt to provide the clinicians with the most recent available data and evidence, and therefore, tell them how this particular imaging…may affect their decision making for the treatment and management of their patients,” says Hossein Jadvar, MD, PhD.

The investigational imaging radiopharmaceutical TLX250-CDx targets the receptor carbonic anhydrase IX (CA9), which is overexpressed in urologic cancers.

“PSMA is a very exciting development in the field of nuclear medicine,” says Hossein Jadvar, MD, PhD.

“There is a rather extensive process of how to develop appropriate use criteria. It is primarily based on literature and evidence, systematic reviews, and analysis of those data,” says Hossein Jadvar, MD, PhD.

The impact of the VISION trial, a study investigating prostate-specific membrane antigen (PSMA)-targeted therapy for advanced prostate cancer, was discussed in a talk presented by Michael J. Morris, MD, at the 2021 Society of Urologic Oncology Annual Meeting.

TLX591-CDx (Illuccix) is a radiopharmaceutical cold kit for the preparation of gallium-68 PSMA-11 injection.