Home › Trials › NCT06780670

Comparing AAA817 to Standard Care for Advanced Prostate Cancer

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

Phase2; Phase3 Interventional Novartis · NCT06780670

This study is testing a new drug called AAA817 to see if it works better than standard treatments for adults with advanced prostate cancer that hasn't responded to other therapies.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment443 (estimated)
Ages18 Years to 100 Years
SexMale
SponsorNovartis Industry-sponsored
Drugs / interventionschemotherapy
Locations72 sites (Los Angeles, California and 71 other locations)
Trial IDNCT06780670 on ClinicalTrials.gov

What this trial studies

This is a Phase II/III clinical trial evaluating the efficacy and safety of AAA817 compared to the investigator's choice of standard care in adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with androgen receptor pathway inhibitors and taxane-based chemotherapy. The study consists of two parts: the Phase II component aims to gather additional information to support the proposed dosing of AAA817, while the Phase III component focuses on comparing the outcomes of AAA817 against standard care. Participants must have progressed on or after treatment with [177Lu]Lu-PSMA targeted therapy and have measurable metastatic disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with PSMA-positive mCRPC who have progressed after prior treatments.

Not a fit: Patients who have not received prior treatments with androgen receptor pathway inhibitors or taxane-based chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced prostate cancer who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise in targeting PSMA-positive prostate cancer, suggesting that this approach may be beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria: ∙

* adults ≥ 18 years of age.
* ECOG performance status of 0 to 2.
* histopathological and/or cytological confirmation of adenocarcinoma of the prostate.
* PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed,
* castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
* Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after \[177Lu\]Lu-PSMA targeted therapy.
* ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
* eGFR as requested by the sponsor

Exclusion Criteria:

* Any investigational agents within 28 days prior to the day of randomization.
* Any 225Ac-based investigational compound used prior to the day of randomization.
* Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
* Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)
* Baseline xerostomia ≥ Grade 2 by CTCAE v.5
* History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed).

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Los Angeles, California and 71 other locations

+22 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate Cancerpost [177Lu]Lu-PSMA targeted therapyPSMA-positivemCRPC adultsMetastatic castration-resistant prostate cancerAAA817[225Ac]Ac-PSMA-617PSMA-based targeted therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.