CAAA617D12302: Oligometastatic Prostate Cancer 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)
Novartis Pharma AG
Prostate cancer is a disease which occurs in males in a small gland in the body called the prostate. Oligometastatic prostate cancer (OMPC) is when the prostate cancer has spread outside the primary site of origin (prostate) to other sites or organs. These lesions outside the prostate are called metastasis and in Oligometastatic disease they are limited in number (e.g., 1 to 5 lesions). This is a phase III open label study with the aim of determining if the trial drug lutetium (177Lu) vipivotide tetraxetan (hereinafter referred to as 177Lu-PSMA-617) can postpone (delay) further progression of OMPC and delay castration/initiation of Androgen Deprivation Therapy (ADT) in adult participants. 177Lu-PSMA-617 is a type of therapy which specifically binds to prostate cancer cells and delivers radiation to those cancer cells. Lutetium-177 (a radioactive metal) is delivered to the tumour with the aim of destroying the cancer cells. 177Lu-PSMA-617 has been studied in prostate cancer in over 8 studies and in over 1090 participants. Gallium (68Ga) gozetotide and Piflufolastat (18F) will be used as imaging agents in this study. Participants will undergo a mandatory Positron Emission Tomography / Computed Tomography (PET/CT) scan using one of the two imaging agents. This PET/CT scan with the imaging agent will allow the study doctor to determine where the cancer cells are in the body. Approximately 450 men in approximately 20 countries will take part in the study. Participants will be part of the study for approximately 36-48 months and will have a ~66% probability of initially receiving 177Lu-PSMA-617 (radionuclide therapy). Men assigned to the 177Lu-PSMA-617 group will be treated with Stereotactic Body Radiation (SBRT) before receiving treatment with 177Lu-PSMA-617. Men assigned to the control (observation) group will be treated with SBRT before starting observation (watchful waiting), and then if eligible will be allowed to receive 177Lu-PSMA-617 once their disease worsens.
London - City & East Research Ethics Committee
Date of REC Opinion
27 Oct 2023
Further Information Favourable Opinion