PIFLUFOLASTAT (18F)

DRUG6 trials

Sponsors

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

Conditions

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 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

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