* CAAA617B12302 Metastatic Castrate Resistant Prostate Cancer
Research type
Research Study
Full title
PSMAfore: A phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Naïve Men with Progressive Metastatic Castrate Resistant Prostate Cancer
IRAS ID
294138
Contact name
Johann De Bono
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-003969-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 17 days
Research summary
Prostate cancer is a disease which occurs in males in a small gland in the body called the prostate. In some cases, the disease may spread beyond the gland and affect different parts of the body developing metastases; in these cases, treatment will be required. This is a phase III open label study with the aim of determining if a new experimental drug named 177Lu-PSMA-617 is safe and effective when compared to a change in androgen receptor-directed therapy (ARDT) in treating metastatic castrate resistant prostate cancer (mCRPC). 177Lu-PSMA-617 is a radioligand therapy which targets prostate cancer cells because it binds specifically to the cancer cells. When the therapy binds to the prostate 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 50 studies and in over 1000 participants. This study is for participants that were previously treated with an androgen receptor-directed therapy but who have not yet been treated with a taxane-containing chemotherapy treatment regimen. Approximately 450 men in approximately 17 countries will take part in the study. Participants will be part of the study for approximately 43 months and have a 50:50 chance of receiving either 6 doses of 177Lu-PSMA-617 (each 6 weeks apart) or treatment with a licensed ARDT (taken as a daily oral tablet). If participants receive ARDT treatment as part of the trial and their disease worsens they may be allowed to change treatment and receive 177Lu-PSMA-617 as part of a crossover arm.
REC name
London - Westminster Research Ethics Committee
REC reference
21/FT/0066
Date of REC Opinion
1 Jun 2021
REC opinion
Further Information Favourable Opinion