Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

Study type

Interventional

Primary purpose

Treatment

Allocation

Randomized

Intervention model

Parallel

Masking

None

Arms

4

Interventions

• Investigators choice of SoC Drug
• AAA817 Drug

• Prostate Cancer

Primary outcome

Biochemical response rate (Phase II) (from date of randomization up to approximately 24 months); Adverse Events (AEs) and Serious Adverse Events (SAEs), and deaths - Phase II (from day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later); Tolerability of the proposed dose of AAA817- Phase II (From on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817); Radiographic progression-free survival (rPFS)- Phase III (from date of randomization up to approximately 24 months); Overall survival (OS)- Phase III (from date of randomization up to approximately 24 months)

• AAA817

• NCT06780670 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read 25 Oct 2026

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.