Comparing AAA817 to Standard Care for Advanced Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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.

Where it's running

• Honor Health Research Institute
  Scottsdale, Arizona, United States Recruiting
• VA Greater LA Healthcare System
  Los Angeles, California, United States Recruiting
• VA Palo Alto Health Care System
  Palo Alto, California, United States Recruiting
• Stanford University Medical Center
  Palo Alto, California, United States Recruiting
• Sansum Clinic
  Santa Barbara, California, United States Recruiting
• Saint Johns Cancer Institute
  Santa Monica, California, United States Recruiting

+43 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.