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
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Missouri
WA Uni School Of Med
RECRUITING
St Louis
Other Locations
Australia
Novartis Investigative Site
RECRUITING
Darlinghurst
Novartis Investigative Site
RECRUITING
Herston
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Chengdu
Novartis Investigative Site
RECRUITING
Tianjin
Israel
Novartis Investigative Site
RECRUITING
Tel Aviv
Japan
Novartis Investigative Site
RECRUITING
Kanazawa
Novartis Investigative Site
RECRUITING
Kashiwa
Novartis Investigative Site
RECRUITING
Kobe
Novartis Investigative Site
RECRUITING
Kyoto
Novartis Investigative Site
RECRUITING
Sapporo
Novartis Investigative Site
RECRUITING
Yokohama
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Taiwan
Novartis Investigative Site
RECRUITING
Taipei
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date:2025-02-27
Estimated Completion Date:2033-04-11
Participants
Target number of participants:432
Treatments
Experimental: Phase II: AAA817 Dose B
AAA817 will be given for a number of cycles; a cycle = 8 weeks
Active_comparator: Phase III: Investigator's choice of SoC
Participants will be given Standard of Care (SOC) treatment per Investigator's choice.
Experimental: Phase II: AAA817 Dose A
AAA817 Dose A will be given for a number of cycles: a cycle = 8 weeks
Experimental: Phase III: Recommended Phase 3 Dose of AAA817
Rp3D of AAA817 will be given for a number of cycles; a cycle = 8 weeks