Next-Generation Imaging

There are 2 FDA-approved PSMA-PET imaging agents: Gallium 68 PSMA-11 (Ga 68 PSMA-11) and piflufolastat F 18.

In this interview, William P. Parker, MD, highlights the development of PSMA-PET imaging in prostate cancer, FDA-approved PSMA-PET agents, and the next steps with this disruptive technique.

“PSMA-PET imaging is something that from a clinical practice perspective is rapidly changing and evolving the field of prostate cancer,” says William P. Parker, MD.

The target of 64Cu SAR-Bombesin is the Gastrin Releasing Peptide receptor, which is found on prostate tumors as well as several other tumors.

Experts weigh in on whether the combined technologies could be the future power couple of prostate cancer diagnosis.

The novel PET imaging agent 68GA-EMP-100 PET measures c-MET expression in renal cell carcinoma.

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

The phase 3 ZIRCON trial is assessing TLX250-CDx as a noninvasive tool to identify clear cell renal cell carcinoma in patients with indeterminate renal masses

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

177Lu-PSMA-617 is approved by the FDA for previously treated patients with PSMA-positive metastatic castration-resistant prostate cancer.

Phillip Kuo, MD, PhD, discusses the abstract, “[68Ga]Ga-PSMA-11 PET baseline imaging as a prognostic tool for clinical outcomes to [177Lu]Lu-PSMA-617 in patients with mCRPC: A VISION substudy,” which was presented at the 2022 ASCO Annual Meeting.

Cleveland clinic physicians Rahul Tendulkar, MD, and Steve Huang, MD, provide expert insight on PSMA-PET imaging and explain how it has changed clinical management of patients with prostate cancer.

“These findings from the SPOTLIGHT study showed high inter-reader and intra-reader agreement for interpretation of 18F-rhPSMA-7.3 PET/CT scans in the setting of biochemical recurrence,” said Phillip Kuo, MD, PhD.

"The SPOTLIGHT study [of 18F-rhPSMA-7.3] highlights what I believe is a paradigm shift with its multidisciplinary [collaboration] in prostate cancer," said Mark Fleming, MD.

The target of the the PET-imaging agent 64Cu SAR-Bombesin is the Gastrin Releasing Peptide receptor (GRPr), which is found on prostate tumors as well as several other tumors

The guidelines now include the use of piflufolastat F 18, along with all approved PSMA-PET imaging agents, for the selection of prostate cancer patients to receive PSMA-targeted radioligand therapy.

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.