Brief Summary
The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dosethe amount of medication taken of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator’s choice of standard of care (SOC) (ARPI change or taxane-based chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells) in adult participants with PSMA-positive metastatic castration resistant prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.
Intervention / Treatment
- Drug: AAA817
- Drug: ARPI
- Drug: Standard of Care
Key Inclusion Criteria:
- Signed informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. must be obtained prior to participation in the study.
- Participants must be adults ≥ 18 years of age.
- Participants must have an ECOG performance status of 0 to 2.
- Participants must have histological, and/or cytological confirmation of adenocarcinomacancer arising from mucus-producing glands in organs of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.
- Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).
- Participants must have PSMA-PET positive disease using a PSMA imagingtests that create detailed images of areas inside the body agent that is approved as per protocol.
- Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).