Study Comparing AAA817 and ARPI with Standard Treatment in Adults with PSMA-positive Advanced Prostate Cancer
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT06855277
This clinical trial is testing a new treatment, AAA817 combined with an androgen receptor pathway inhibitor (ARPI), to see if it can better control advanced prostate cancer compared to standard treatments. The study focuses on patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have not received certain chemotherapy treatments before.
Patient Parameters
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Program Overview
The study aims to find out if a new treatment, AAA817 combined with an androgen receptor pathway inhibitor (ARPI), can help control advanced prostate cancer better than the usual treatments. It is for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have not been treated with taxane-based chemotherapy for mCRPC or any PSMA-targeting radioligand therapy before. Participants will be randomly assigned to receive either the new treatment or the standard treatment, which could be a change in ARPI or chemotherapy. The study will take place in the USA and other countries.
Description
This is a phase III study where participants will be randomly assigned to receive either the new treatment (AAA817 with ARPI) or the standard treatment (ARPI change or chemotherapy). Before starting, participants will have a PET/CT scan to confirm PSMA-positive cancer. Those eligible will be divided into two groups:
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New Treatment Group: Participants will receive up to 6 doses of AAA817, given through an IV, along with an ARPI (either enzalutamide or abiraterone) as chosen by the doctor. Treatment will continue until the end of the study criteria.
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Standard Treatment Group: Participants will receive either a change in ARPI or taxane-based chemotherapy (docetaxel or cabazitaxel) as chosen by the doctor. The duration of chemotherapy will follow local guidelines and the study's end criteria.
Both groups will receive supportive care as needed, including androgen deprivation therapy (ADT). Safety will be monitored throughout the study, and participants cannot switch between treatment groups.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older and have signed informed consent.
- Must have a performance status score of 0 to 2, indicating good overall health.
- Must have confirmed prostate adenocarcinoma (not mixed with other types).
- Must not have received taxane-based chemotherapy for mCRPC, but can have received it for mHSPC if appropriate for further treatment.
- Must have PSMA-PET positive cancer.
- Must have advanced prostate cancer that has progressed on ARPI treatment.
Exclusion Criteria
- Cannot have had previous treatment with radioligand therapy or certain radioisotopes.
- Cannot have had recent extensive radiotherapy.
- Cannot have certain gene mutations related to prostate cancer.
- Cannot have had other cancer treatments within 28 days before starting the study.
- Cannot have other active cancers that affect life expectancy or disease assessment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Kansas Hospital | 66160 | Kansas City | Kansas |
| Carolina Urologic Research Center | 29572 | Myrtle Beach | South Carolina |
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