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
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
About This Trial
- This clinical trial is testing a new experimental drug called AAA817 compared to existing standard treatments for advanced prostate cancer.
- It is for adults whose cancer has continued to grow or spread despite receiving prior hormone therapy, chemotherapy, and a targeted radiation therapy known as PSMA treatment.
- If you participate, you will be randomly assigned to receive either the new study drug or a standard therapy chosen by your doctor.
- Before considering this trial, you should know that you must be able to perform regular daily activities and cannot have severe active heart, kidney, or nervous system conditions.
More Information
- 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
Who Can Enroll
- Age Range: 18 - 100 years
- Gender: Male
- Who This Trial is For: This clinical trial is testing a new experimental drug called AAA817 compared to existing standard treatments for advanced prostate cancer.
Study Details
- Start Date: February 27, 2025
- Lead Sponsor: Novartis Pharmaceuticals
Full Eligibility 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 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.
Treatments
- Drug: Investigators choice of Standard of Care
- Drug: AAA817