PSMA-positive mCRPC
Conditions
Interventions
Experimental:Investigational Arm: AAA817+ARPI (enzalutamide or abiraterone)
- Participants will receive AAA817 infusion directly into a vein with ARPIs.
Experimental:Investigational Arm: AAA817
-Pa
Sponsors
Yamauchi Kyosuke
Eligibility
Sex/Gender
Male
Inclusion criteria
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 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. Other protocol-defined inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: - 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. Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1. Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic Progression Free Survival (rPFS) [Time Frame: 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. | — |
Countries
Australia, China, Japan, Singapore
Contacts
Public ContactKyosuke Yamauchi
Novartis Pharma. K.K.
Outcome results
None listed