Tests AAA817 Against Standard Care in Advanced Prostate Cancer
Compares AAA817 with standard treatment in men with advanced prostate cancer after prior therapy.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Petaling Jaya and Putrajaya, MalaysiaSee the 2 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adult men with prostate cancer that has spread, no longer responds to hormone-lowering treatment, and shows PSMA on a scan. Their cancer must have grown after earlier treatment with [177Lu]Lu-PSMA.
- Age
- 18 years or older, up to 100 years.
- Sex
- Men only.
- Disease stage
- Prostate adenocarcinoma (confirmed by tissue or cell tests) that has spread (mCRPC), with at least 1 metastatic lesion on imaging. PSMA-positive on a PSMA PET/CT scan. Testosterone at castrate level (< 50 ng/dL or < 1.7 nmol/L). ECOG performance status 0 to 2.
- Earlier treatment
- Must have had an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy. The cancer must have grown on or after [177Lu]Lu-PSMA targeted therapy.
- Biomarker or test result
- PSMA-positive disease on a PSMA PET/CT scan with an approved PSMA imaging agent.
Main reasons for not taking part
- Any investigational agent within 28 days before randomization
- Any 225Ac-based investigational compound used before randomization
- History of CNS metastases that are unstable, cause symptoms, or need corticosteroids
- Acute kidney injury or chronic kidney disease at the same time
- Dry mouth (xerostomia) of Grade 2 or worse at the start
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT06780670, who can take part
Where in Malaysia
- Petaling JayaPetaling Jaya, MalaysiaTaking people
- PutrajayaPutrajaya, MalaysiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06780670EU 2024-512342-42-00
- Record updated
- 22 September 2026
- Original description
This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after [177Lu]Lu-PSMA targeted therapy.Read full original descriptionShow less
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
This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after [177Lu]Lu-PSMA targeted therapy.
Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment
Inclusion: 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: 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); 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 2 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; Baseline xerostomia ≥ Grade 2 by CTCAE v.5.