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Study Comparing AAA817+ARPI Versus Standard of Care in PSMA-positive mCRPC

This study is testing if a treatment called AAA817, combined with an ARPI (androgen receptor pathway inhibitor), works better than standard care for men with metastatic castration-resistant prostate cancer (mCRPC) that is PSMA-positive. AAA817 is a radioligand therapy that attaches to cancer cells and uses radiation to kill them. An ARPI blocks male hormones that help cancer grow. Standard care in this study could be a different ARPI, chemotherapy, or another radioligand therapy (AAA617). The study is looking to see if AAA817+ARPI can prevent the cancer from growing or spreading for a longer time. You might be able to join if you are an adult male with PSMA-positive mCRPC and meet other specific health criteria.

Study design
This is a Phase 3, open-label, randomized study involving about 940 participants. Participants will be assigned by chance to receive either the AAA817+ARPI combination or standard care.
What's involved
Participants will undergo a PET/CT scan to confirm PSMA positivity. Those randomized to the investigational arm will receive up to 6 doses of AAA817 intravenously, with or without an ARPI.
Compensation
Not stated in the trial record.
Follow-up
The study will assess how long participants live without their cancer progressing, up to approximately 40 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06855277

Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

Recruiting
PHASE3Ages 18+InterventionalDiagnostic
Novartis Pharmaceuticals
~940 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:AAA817ARPIStandard of Care

At a glance

Recruiting sites
95 of 95 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic Progression Free Survival (rPFS)
Measured over From the date of randomization to the date of the first documented radiographic disease progression using conventional imaging, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Conditions

Prostate Cancer

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Where it's being run

95 sites across 51 states
China8
Japan7
South Korea6
New York5
Florida3
Texas3
Singapore3
Taiwan3

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Eligibility criteria

Inclusion

Signed informed consent must be obtained prior to participation in the study.
Participants must be adults ≥ 18 years of age.
Participants must have an ECOG performance status of 0 to 2.
Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.
Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.
Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).
Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.
Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).
Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.

Exclusion

Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, \[177Lu\]Lu-PSMA, \[177Lu\]-DOTA, or Radium- 223.)
Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).
Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.

What this trial measures

  • Radiographic Progression Free Survival (rPFS)From the date of randomization to the date of the first documented radiographic disease progression using conventional imaging, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

    Time to radiographic disease progression or death due to any cause.