Lutetium (177Lu) Vipivotide Tetraxetan + ARPI for Prostate Cancer
(PSMAndARPI Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess whether the combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI improves radiographic progression-free survival (rPFS) or time to death compared to AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the castrate resistant prostate cancer (CRPC) setting.
Research Team
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Eligibility Criteria
This trial is for men with advanced prostate cancer that has spread and is PSMA-positive. They must have previously progressed on ARPI therapy, not received taxane in the CRPC setting, have low testosterone levels, show disease progression either in soft tissue or bone, and be able to perform daily activities (ECOG 0-2).Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AAA617 with or without ARPI every 6 weeks for 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Abiraterone
- Enzalutamide
- Lutetium (177Lu) Vipivotide Tetraxetan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD