A phase III, open-label, multi-center, randomized study comparing AAA817+ARPI versus standard of care in adult participants with PSMA-positive metastatic castration resistant prostate cancer

Clinical Trial Details

The purpose of this study is to evaluate the safety and effectiveness of AAA817 and an Androgen receptor pathway inhibitor (ARPI) given compared to the standard of care options.

AAA817 is experimental, which means it is being tested and is not yet approved by the United States Food and Drug Administration (FDA).

In this study, AAA817 will be given intravenously (meaning through a needle in the vein directly into the blood). The Androgen receptor pathway inhibitor (ARPI) will be given orallly.

Participants will be randomized into one of two treatment groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Participation is expected to last 6.1 years.

Key Eligibility:

Open to men and women above the age of 18 who have histological, and/or cytological confirmation of adenocarcinoma of the prostate.
Participants with mixed histology (neuroendocrine) are not eligible

Detailed eligibility will be reviewed when contacting the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

646-962-2072
guonc@med.cornell.edu

Primary Investigator(s)

Scott T. Tagawa, MD, MS

Protocol ID(s)

Weill Cornell Medicine IRB #:

2505028892

ClinicalTrials.gov:

NCT06855277

Status

Open to Enrollment

Age Group

Adult

Disease

Prostate Cancer