PIFLUFOLASTAT (18F)
Sponsors
Novartis Pharma AG, Canisius Wilhelmina Ziekenhuis, Blue Earth Diagnostics, Novartis Pharmaceuticals
Conditions
Oligometastatic prostate cancer (OMPC)PSMA-positive mCRPC with prior exposure to at least one prior ARPIProstate Cancer
Phase 1
Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC
WithdrawnNCT06881823
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
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
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
Start: 2025-01-23Target: 742Updated: 2025-07-31