AAA817 + ARPI for Advanced Prostate Cancer

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

Recruiting Phase 3 Interventional Study
Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 100
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
940 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for

This trial is looking for adult men with a specific type of prostate cancer called PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Participants will receive a treatment called AAA817 along with other medications to see if it improves their condition.

Are You a Good Fit for This Trial?
Rules you out Mixed histology prostate cancer (neuroendocrine)Taxane-based chemotherapy for mCRPC

You may be able to join if

  • I am an adult aged 18 or older.
  • I have been diagnosed with prostate cancer.
  • I have not had treatment with taxane-based chemotherapy for mCRPC.
  • I have progressive disease while on androgen receptor pathway inhibitor.
  • I have a PSMA-positive disease confirmed by a PSMA imaging test.
  • I can provide informed consent to participate.

You may not be able to join if

  • I have received any radiopharmaceutical treatments for cancer.
  • I have received external beam radiotherapy within the last 6 weeks.
  • I have had any prior PARP inhibitor or other systemic therapy for mCRPC.
  • I have received chemotherapy, immunotherapy, or similar treatments within the last 28 days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
The purpose of this study is to determine whether \[225Ac\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \[177Lu\]Lu-PSMA-617 (AAA617)) in ad…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: * 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 adenocarc…
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