Metastatic PC: Patient Selection for PSMA-Directed Therapy

PSMA PET/CT CONFIRMED PATIENT ELIGIBILITY FOR PSMA-DIRECTED THERAPY IN THE PHASE 3 VISION TRIAL¹

Outcomes support gallium Ga 68 gozetotide PSMA PET/CT imaging as a method to select patients who may be eligible for PSMA-directed therapy¹ 

VISION study design

• The efficacy of LOCAMETZ for selecting patients for PSMA-directed therapy was established in the randomized, multicenter, open-label, phase 3 VISION study and the VISION reader substudy that evaluated imaging interpretation agreement

• Using gallium Ga 68 gozetotide PSMA PET/CT imaging, 831* of 1003 patients were identified as eligible for the study and then randomized 2:1 to receive either lutetium Lu 177 vipivotide tetraxetan plus BSOC (n=551) or BSOC alone (n=280)

*The eligibility criteria for PSMA imaging were met in 869 patients. 831 were judged to have met all the trial eligibility criteria, including the PSMA imaging criteria, and were randomized 2:1 to each study arm.^1,2

Based on their PSMA-positive status and other criteria

Consider a PSMA PET/CT scan to select patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

BSOC, best standard of care; CT, computed tomography; PC, prostate cancer; PET, positron emission tomography; PSMA, prostate-specific membrane antigen.

^a The eligibility criteria for PSMA imaging were met in 869 patients. 831 were judged to have met all the trial eligibility criteria, including the PSMA imaging criteria, and were randomized 2:1 to each study arm.^1,2

PC With Suspected Metastasis: Before Initial Definitive Therapy

THE RECEPTOR-BASED APPROACH OF PSMA PET IMAGING DEMONSTRATED STRONG PREDICTIVE VALUE WHEN COMPARED AGAINST HISTOPATHOLOGY¹

The efficacy of LOCAMETZ in men with suspected metastasis who are candidates for initial definitive therapy has been established based on a study of another formulation of gallium Ga 68 gozetotide¹

• PSMA-PreRP was an open-label, prospective, 2-center study of 325 patients with biopsy-proven prostate cancer who were considered candidates for prostatectomy and pelvic lymph node dissection¹

• Each patient received a single gallium Ga 68 gozetotide PET/CT or PET/MRI from mid-thigh to skull base¹

• For each patient, gallium Ga 68 gozetotide PET results and reference standard histopathology obtained from dissected pelvic lymph nodes were compared by region (left hemipelvis, right hemipelvis, and other)¹

   

Compared with reference standard histopathology, PSMA PET imaging demonstrated¹:

MRI, magnetic resonance imaging; PSA, prostate-specfic antigen.

For patients with suspected metastasis who are candidates for initial definitive therapy, consider a PSMA PET/CT scan if you see^1,a:

• Serum PSA of at least 10 ng/mL

• Tumor stage cT2b or greater

• Gleason score >6

^a Based on inclusion criteria for the PSMA-PreRP study. Institutional guidelines may vary.

PC: Suspected Biochemical Recurrence

>9 OF 10 EVALUABLE PATIENTS WITH EVIDENCE OF BIOCHEMICAL RECURRENCE WERE FOUND TO BE TRUE POSITIVE AFTER PSMA PET IMAGING¹

The efficacy of LOCAMETZ in men with suspected recurrence based on elevated serum PSA level has been established based on studies of another formulation of gallium Ga 68 gozetotide¹ 

• PSMA-BCR was an open-label, 2-center prospective study of 635 patients who had biochemical evidence of recurrent prostate cancer after definitive therapy^1,3

• Biochemical recurrence was defined as PSA >0.2 ng/mL more than 6 weeks after prostatectomy or an increase in serum PSA of at least 2 ng/mL above nadir after definitive radiotherapy^1,3

• All patients received a single gallium Ga 68 gozetotide PSMA PET/CT or PSMA PET/MRI from mid-thigh to skull base; 210 had composite standard information collected in a PET-positive region (evaluable patients) consisting of at least 1 of the following: Histopathology, imaging (bone scintigraphy, CT, or MRI) acquired at baseline or within 12 months after gallium Ga 68 gozetotide PET, or serial serum PSA^1,3

After 3 members of a pool of 9 independent central readers evaluated each PSMA PET/CT and PSMA PET/MRI scan¹:

	91% of evaluable patients were found to be true positive in 1 or more regions against the composite reference standard (95% CI, 88%-95%).a
	Higher PSA = greater chance of detecting PSMA+ lesions The likelihood of identifying a gallium Ga 68 gozetotide PET-positive lesion in this study generally increased with higher serum PSA level.

^a Among the pool of 9 readers used in the study, the proportion of patients who were true positive in 1 or more regions ranged from 82% to 97%.

For patients with suspected recurrence, consider a PSMA PET/CT scan if you see^1,a:

• PSA >0.2 ng/mL more than 6 weeks after prostatectomy or

• Increase in serum PSA of at least 2 ng/mL above nadir after definitive radiotherapy

^a Based on inclusion criteria for the PSMA-BCR study. Institutional guidelines may vary. 

Referring Patients for a PSMA PET/CT Scan

PSMA PET IMAGING^* CAN HELP GUIDE MANAGEMENT OF PROSTATE CANCER ACROSS MULTIPLE SETTINGS^1,3-6

Consider patients in your practice who could be candidates for a PSMA PET/CT scan and timing

^*PSMA PET imaging includes PSMA PET/CT and PSMA PET/MRI.
^a Based on inclusion criteria for the PSMA-PreRP study. Institutional guidelines may vary.
^b Based on inclusion criteria for the PSMA-BCR study. Institutional guidelines may vary.

REFERRING YOUR PATIENTS FOR A PSMA PET/CT SCAN STARTS WITH 1 SIMPLE STEP