Next-Generation Imaging

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.

“I believe we are getting to an era where we will be able to cure a significant subset of patients who we are not able to cure today,” says Neil H. Bander, MD.

The PROPELLER trial is exploring the novel PSMA-PET imaging product 64Cu-SAR-bisPSMA in patients with treatment-naïve, histologically confirmed prostate cancer who are scheduled for radical prostatectomy.

In a recent interview, Neil H. Bander, MD, emphasizes some of the specific innovations that are on the horizon for PSMA.

"This is a way for us to get high doses of radiation to sites of tumors," says Michael S. Hofman, MBBS (Hons), FAANMS, FICIS.

“Our preclinical therapy models all show us that the combination of the 2 agents [alpha and beta particles] is substantially superior to either agent alone,” says Neil H. Bander, MD.

“There's a hope that we can modulate PSMA expression with some drugs, increase the amount of PSMA on the tumors, [and] therefore increase the amount of radiation that we can target,” says Michael S. Hofman, MBBS (Hons), FRACP, FAANMS, FICIS.

“It's very clear that PSMA-PET imaging is having…a transformative impact on our ability to image metastatic disease, in that it is much more sensitive than we've had for the last 50 plus years—and also, 98% specific,” says Neil H. Bander, MD.

“We hope to further investigate next-generation PSMA-targeting molecules, develop new biomarkers to try to predict and monitor response to these novel therapies, optimize combinations with other treatments, and do some discovery research, including artificial intelligence [and] deep learning of our images,” says Michael S. Hofman, MBBS (Hons), FRACP, FAANMS, FICIS.

“We expect an outcome from the FDA next year and if that's positive, we expect global, widespread availability of this as a new option for men with metastatic castration-resistant prostate cancer,” says Michael S. Hofman, MBBS (Hons), FRACP, FAANMS, FICIS.

The SECURE trial is exploring the PSMA PET imaging product 64Cu-SAR-bisPSMA and the PSMA targeted therapy 67Cu-SAR-bisPSMA.

The oncology provider will enable patient access to the PSMA-PET imaging agent piflufolastat F 18, which the FDA approved in May 2021 for identifying suspected metastasis or recurrence of prostate cancer.