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PIFLUFOLASTAT (18F)

DRUG7 trials

Sponsors

Novartis Pharma AG, Canisius Wilhelmina Ziekenhuis, Centre Hospitalier Universitaire De Toulouse, Novartis Pharmaceuticals, Blue Earth Diagnostics

Conditions

Oligometastatic Prostate Cancer (OMPC)Oligometastatic prostate cancer (OMPC)PSMA-positive mCRPC with prior exposure to at least one prior ARPIProstate Cancerprostate cancer

Phase 1

Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC
WithdrawnNCT06881823
Novartis PharmaceuticalsProstate Cancer
Start: 2026-06-29End: 2033-06-01Updated: 2025-12-29
A phase Ib/II open-label, multi-center study of the DNA protein kinase inhibitor AMO959 with lutetium (177Lu) vipivotide tetraxetan (AAA617) in combination with an androgen receptor pathway inhibitor (ARPI) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)
Not yet recruitingCTIS2025-521859-23-00
Novartis Pharma AGPSMA-positive mCRPC with prior exposure to at least one prior ARPI
Target: 61Updated: 2026-03-06

Phase 3

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
RecruitingNCT05939414
Novartis PharmaceuticalsOligometastatic Prostate Cancer (OMPC)
Start: 2024-03-12End: 2031-10-03Target: 450Updated: 2026-09-01
An International, Prospective, Open-label, Multi-center, Randomized Phase III Study comparing lutetium (177Lu) vipivotide tetraxetan (AAA617) versus Observation to delay castration or disease recurrence in adult male patients with prostate-specific membrane antigen (PSMA) positive Oligometastatic Prostate Cancer (OMPC)
RecruitingCTIS2022-502956-29-00
Novartis Pharma AGOligometastatic prostate cancer (OMPC)
Start: 2024-07-01Target: 215Updated: 2026-01-19
Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET/CT for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients (PSMA-SELECT).
Active, not recruitingCTIS2024-518171-59-00
Canisius Wilhelmina ZiekenhuisProstate Cancer
Start: 2025-01-23Target: 742Updated: 2025-07-31

Phase 4

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy
CompletedNCT06604442
Blue Earth DiagnosticsProstate Cancer
Start: 2024-12-04End: 2025-08-29Updated: 2026-07-13
ECETEP : Pilot study evaluating PSMA positron emission tomography for monitoring clinically significant prostate cancer after focal HIFU treatment
Not yet recruitingCTIS2026-525181-22-00
Centre Hospitalier Universitaire De Toulouseprostate cancer
Target: 30Updated: 2026-06-25

Related Papers

An intra-patient contemporaneous comparison of 18F-piflufolastat and 18F-flotufolastat urinary radioactivity and pelvic region detection rates in men with low PSA biochemical recurrence of prostate cancer after radical prostatectomy
European Journal of Nuclear Medicine and Molecular Imaging2026-02-23
PSMA-delay castration (DC): An open-label, multicenter, randomized phase 3 study of [ <sup>177</sup> Lu]Lu-PSMA-617 versus observation in patients with metachronous PSMA-positive oligometastatic prostate cancer (OMPC).
Journal of Clinical Oncology2025-05-284 citations
Intra-patient comparison of urinary radioactivity after <sup>18</sup> F-piflufolastat and <sup>18</sup> F-flotufolastat PET in men with low PSA biochemical recurrence of prostate cancer who have had radical prostatectomy.
Journal of Clinical Oncology2025-02-10