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
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
Detailed description
Study CAAA817A12201 consists of 2 parts: a randomized, open-label, international, multicenter, phase II study (Phase II) to collect more information to support the proposed dose of AAA817 and a randomized, open-label, international, multicenter, 2- arm phase III study (Phase III) aimed to evaluate the efficacy and safety of proposed dose of AAA817 vs. investigator's choice of standard of care (SoC) in the treatment of adult participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who had treatments with ARPI and taxane-based chemotherapy, and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. The purpose of the phase II part (Phase II) of this study is to collect additional information to support proposed phase III dose of AAA817.
Arms & interventions
- DrugInvestigators choice of SoC
The control treatment in Phase III is investigator's choice of SoC
- DrugAAA817
The investigational treatment is AAA817
- DrugAAA817
The investigational treatment is AAA817
- DrugAAA817
Investigational treatment is the Dose B of AAA817
Outcome measures
Primary
Biochemical response rate (Phase II)
Biochemical response rate as defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second measurement
Time frame: from date of randomization up to approximately 24 months
Adverse Events (AEs) and Serious Adverse Events (SAEs), and deaths - Phase II
Safety defined as the type, incidence and severity of AEs and SAEs, and deaths
Time frame: from day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later
Tolerability of the proposed dose of AAA817- Phase II
Percentage of participants who experienced Dose interruptions, reductions, discontinuation, dose intensity and duration of exposure
Time frame: From on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817
Radiographic progression-free survival (rPFS)- Phase III
Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis
Time frame: from date of randomization up to approximately 24 months
Overall survival (OS)- Phase III
Percentage of participants who are alive or who are lost to follow-up at the time of analysis
Time frame: from date of randomization up to approximately 24 months
Secondary
Radiographic progression-free survival (rPFS)- Phase II
Time frame: from date of randomization up to approximately 24 months
Progression free survival (PFS)- Phase II
Time frame: from date of randomization up to approximately 24 months
Overall response rate (ORR)- Phase II
Time frame: from date of randomization up to approximately 24 months
Disease control rate (DCR)- Phase II
Time frame: from date of randomization up to approximately 24 months
Overall survival (OS)- Phase II
Time frame: from date of randomization up to approximately 24 months
Progression free survival (PFS) -Phase III
Time frame: from date of randomization up to approximately 24 months
Overall response rate (ORR)- Phase III
Time frame: from date of randomization up to approximately 24 months
Disease control rate (DCR) -Phase III
Time frame: from date of randomization up to approximately 24 months
Duration of response (DoR)- Phase III
Time frame: from date of randomization up to approximately 24 months
Time to first radiographic soft tissue progression (TTSTP)- Phase III
Time frame: from date of randomization up to approximately 24 months
First symptomatic skeletal event (TTSSE)_Phase III
Time frame: from date of randomization up to approximately 24 months
Prostate specific antigen (PSA) response -Phase III
Time frame: from date of randomization up to approximately 24 months
Patient reported disease related symptoms and health-related quality of life (HRQoL): Phase III
Time frame: from date of randomization up to approximately 24 months
Time to worsening on the Worst Pain: Phase III
Time frame: from date of randomization up to approximately 24 months
Eligibility criteria
Study locations (27)
VA Greater LA Healthcare System
Los Angeles, California, 90073
VA Palo Alto Health Care System
Palo Alto, California, 94304-1207
Stanford University Medical Center
Palo Alto, California, 94304
Sansum Clinic
Santa Barbara, California, 93105
Saint Johns Cancer Institute
Santa Monica, California, 90404
Hartford Hospital
Hartford, Connecticut, 06102
AdventHealth
Orlando, Florida, 32804
University Cancer and Blood Center LLC
Athens, Georgia, 30607
Emory University
Atlanta, Georgia, 30322
Indiana University
Indianapolis, Indiana, 46202
University of Kansas Hospital
Kansas City, Kansas, 66160
East Jefferson Hospital
Metairie, Louisiana, 70006
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
WA Uni School Of Med
St Louis, Missouri, 63110
Nebraska Cancer Specialists
Omaha, Nebraska, 68154
New Jersey Urology LLC
Voorhees Township, New Jersey, 08043
Associated Med Professionals of NY
Syracuse, New York, 13210
Montefiore Medical Center
The Bronx, New York, 10467
Central Ohio Urology Group
Gahanna, Ohio, 43230
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Texas Oncology
Dallas, Texas, 75251
Urology San Antonio
San Antonio, Texas, 78229
Utah Intermountain Medical Center
Murray, Utah, 84107
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226