Next-Generation Imaging

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.

"Combining mpMRI and 68Ga-PSMA PET/CT in a primary diagnostic setting could better identify where to target on biopsy, increasing the diagnostic yield, improving concordance with underlying tumor grade and therefore improving management recommendations," the authors wrote.

In the majority of patients, the study findings resulted in impactful changes to clinical management.

The nomogram was significantly prognostic of key clinical end points and achieved outcomes comparable to STAR-CAP and superior to other established risk-stratification tools.

“This zone-dependent biopsy strategy warrants prospective evaluation to optimize the extent of systematic biopsies in presence of suspicious mpMRI lesions,” the authors wrote.

"Clinicians taking care of patients with high-risk prostate cancer being assessed for prostatectomy can use a positive [PSMA] PET scan as a true positive, whereas a negative scan cannot be used to exclude disease or inform nodal dissection," wrote Joseph Osborne, MD, PhD, and colleagues.

The designation, which will expedite the regulatory review of LuPSMA in this setting, is primarily based on findings from the phase 3 VISION trial.

The phase 3 SPLASH trial is exploring the novel PSMA-targeted therapy PNT2002 in patients with metastatic castration-resistant prostate cancer and progressive disease.

The PET radiopharmaceutical led to a shift in the management of nearly two-thirds of men with biochemical recurrence of prostate cancer.

"This is the first time that I have seen such impressive responses with an immunotherapy product. The responses of my patients in the trial are far beyond my expectations," said study investigator Susan F. Slovin, MD, PhD.

The theranostic 64/67Cu SAR-bisPSMA combines the PSMA PET imaging product 64Cu-SAR-bisPSMA and the PSMA targeted therapy 67Cu-SAR-bisPSMA.

Susan F. Slovin, MD, PhD, highlights 177Lu-PSMA-617 and the radiopharmaceutical revolution in metastatic castration-resistant prostate cancer.

Preclinical data have provided further evidence that adding the novel radiosensitizer idronoxil to 177Lu-PSMA-617 may improve survival in patients with metastatic castration-resistant prostate cancer.

“Targeted ligand therapy is extremely exciting,” says Ketan K. Badani, MD.

The pivotal phase 3 SPLASH study is exploring the novel PSMA-targeted therapy PNT2002 in patients with metastatic castration-resistant prostate cancer.

ARX517 is being explored in patients with prostate cancer and other PSMA-expressing solid tumors.

Patient tumors must express PSMA as identified by 68Ga-PSMA-11 or 18F-DCFPyl PSMA PET/CT scanning.

The theranostic 64/67Cu SAR-bisPSMA combines the PSMA PET imaging product 64Cu-SAR-bisPSMA and the PSMA targeted therapy 67Cu-SAR-bisPSMA.

A recent analysis suggested that nomograms could predict outcomes with the PSMA-targeted agent Lutetium-177–PSMA-617 in patients with metastatic castration-resistant prostate cancer.

“This is a completely new therapeutic concept; a precision medicine that delivers radiation directly to a high incidence tumor," said Ken Herrmann, MD.

Photodynamic diagnosis with blue light was associated with improved outcomes compared to white light cystoscopy in patients with bladder cancer who received TURBT.

With supporting data from larger series, using Ga-68 PSMA PET as a lymph node invasion prediction tool instead of nomograms could avoid unnecessary lymphadenectomies during radical prostatectomy,” said Yakup Kordan, MD.

“This confirms the potential of PSMA PET to distinguish between risk groups for MFS,” said Dr. Christoph Würnschimmel.

Piflufolastat F 18 effectively detected and pinpointed metastatic lesions with high positive predictive value, regardless of anatomic region.

The designation, which will expedite the development and review of 177Lu-PSMA-617 in this setting, is based on findings from the phase 3 VISION trial.