PSMAcTION: A Phase II/III, Open-label, International, Multicenter, Randomized Study of AAA817 Versus Standard of Care in the Treatment of Adult Participants With PSMA Positive Metastatic Castration-resistant Prostate Cancer Who Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Novartis Pharmaceuticals (industry)

Phase: 2/3

Start date: Feb. 27, 2025

Planned enrollment: 432

Trial ID: NCT06780670
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Investigational Drug AI Analysis

chevron Show for: AAA817 (225Ac-PSMA-617)

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Goal: To establish a phase III dose of AAA817 and evaluate its efficacy and safety against investigator-selected standard of care after progression on or after lutetium-177–PSMA therapy.

Patients: Adults with PSMA-positive metastatic castration-resistant prostate adenocarcinoma, ECOG performance status 0–2, and prior androgen receptor pathway inhibitor and taxane chemotherapy. Patients must have castrate testosterone levels and at least one metastatic lesion. Key exclusions include prior actinium-225 investigational therapy, significant kidney disease, and grade 2 or worse dry mouth at baseline.

Design: International, multicenter, randomized, open-label study. Phase II compares two AAA817 doses to support dose selection; phase III compares the recommended dose with investigator-selected standard of care.

Treatments: AAA817 ([225Ac]Ac-PSMA-617) is an investigational radioligand that binds PSMA on prostate cancer cells and delivers alpha radiation from actinium-225. In a noncomparative phase I study, 21 of 40 patients previously treated with lutetium-177–PSMA therapy had a PSA decline of at least 50%; this does not establish a survival benefit. Dry mouth was common in that study. AAA817 is given in 8-week cycles; the phase III comparator is investigator-selected standard-of-care treatment.

Outcomes: Phase II primarily measures confirmed PSA declines of at least 50%, adverse events, and dose tolerability. Phase III primarily measures radiographic progression-free survival and overall survival. Additional measures include tumor response, disease control, PSA response, skeletal events, pain, and patient-reported quality of life, with efficacy follow-up of approximately 24 months.

Burden on patient: Estimated moderate burden. Treatment visits during 8-week AAA817 cycles, PSMA PET/CT for eligibility, follow-up imaging, safety assessments, and questionnaires add to routine cancer care. Radioligand treatment may require travel to a specialist center. The protocol information provided does not specify frequent pharmacokinetic blood draws or mandatory biopsies.

Last updated: Sep 2026

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