biomarkersBiomarker

PSMA expression by PET (PSMA-positive)

aka PSMA PET positive, PSMA-positive, PSMA expression, PSMA PET, Ga-68 PSMA-11 uptake, piflufolastat PET, PSMA-avid, PSMA uptake greater than liver

PSMA-positive means prostate cancer deposits light up on a PSMA PET scan more than the liver does. It is the entry ticket for lutetium-177 PSMA therapy and the basis of the imaging that now stages most advanced prostate cancer.

Gallium-68 gozetotide (Locametz, Illuccix), piflufolastat F-18 (Pylarify) and flotufolastat F-18 (Posluma) image PSMA. The Pluvicto label requires selection with Locametz or another approved PSMA PET product based on PSMA expression in tumours; the VISION and PSMAfore trials defined positivity as at least one metastatic lesion with uptake greater than liver parenchyma and no PSMA-negative lesions above size limits (short axis 1 cm in soft tissue, 2.5 cm in nodes, or any measurable bone lesion with soft tissue component), and the label's clinical studies section repeats this. Pluvicto is now labelled for both PSMA-positive metastatic castration-resistant disease after an ARPI and, since 2026, PSMA-positive metastatic androgen pathway modulation-naive or -sensitive disease with an ARPI.

Part ofPSMA· FOLH1 All readouts

PSMA: what it is and how drugs act on it · animated schematic, not to scale

Target · the protein and the cell it sits on
Drug · antibody, small molecule, cell or radioligand
Effect · signal, damage or kill

In plain words · A protein on prostate cancer cells that lets doctors both see the cancer on a PET scan and hit it with a radioactive drug.

PET 2 approval thresholds

What it means for a patient

A PSMA PET scan that shows your cancer taking up the tracer more strongly than your liver makes you PSMA-positive, which is required for lutetium-177 PSMA treatment. The same scan is used to find where the cancer is. If some deposits do not take up the tracer, the treatment may not reach them, which is why the scan is read lesion by lesion.

Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.

Scoring rule

At least one metastatic lesion with PSMA PET uptake greater than normal liver, and no PSMA-negative measurable lesions (the VISION criteria) on an approved PSMA PET tracer.

“Select patients for treatment using LOCAMETZ ® or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors.”
PLUVICTO prescribing information

Thresholds used in approvals

Threshold	Drug	Cancer	Regulator	Source
PSMA-positive by PSMA PET	Lutetium-177 vipivotide tetraxetan	Metastatic castration-resistant prostate cancer	FDA	label
PSMA-positive by PSMA PET	Lutetium-177 vipivotide tetraxetan	Metastatic hormone-sensitive prostate cancer	FDA	label

Drugs whose label names it

Lutetium-177 vipivotide tetraxetan

Tests that measure it

PSMA PET (Ga-68 PSMA-11, F-18 piflufolastat, F-18 flotufolastat)

Trials that name this readout

Matched on the name and aliases of the readout in the title, setting and summary of each trial; a match is a mention, not proof the readout was an entry criterion.