Metastatic Castration-resistant Prostate Cancer
Conditions
Interventions
JAPAN SAFETY RUN-IN SUB-STUDY
Drug: AZD2265
Main Phase 3 study
Drug: AZD2265
Drug: Cabazitaxel
Drug: Abiraterone
Drug: Enzalutamide
Drug: Radium-223
Sponsors
Hibi Kazushige
Eligibility
Inclusion criteria
Inclusion criteria: - 18 years of age or more. - Diagnosis of adenocarcinoma of prostate. - Must have had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone. - Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and/or non-measurable) that is suitable for repeated assessment by CT and/or MRI and/or bone scan. - Previously treated with at least 2 cycles of PSMA-directed Beta-emitting radioconjugate. - Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC. - Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.). - Positive PSMA PET/CT scans, obtained with PSMA ligands (68Ga-PSMA-11 or 18F-DCFPyL). - ECOG performance status of 0 to 2. - Adequate organ and bone marrow function as described in study protocol. - Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention. - Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.
Exclusion criteria
Exclusion criteria: - Prior treatment with an alpha-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted). - Progression on PSMA-directed Beta-emitting radioconjugate prior to the administration of Cycle 3. - Receipt of > 6 cycles of PSMA-directed Beta-emitting therapeutic RC. - History of another primary malignancy, with exceptions. - Persistent toxicities (CTCAE Grade >_ 2) caused by previous anticancer therapy, with exceptions. - Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention. - Clinically significant ECG abnormalities, with exceptions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JAPAN SAFETY RUN-IN SUB-STUDY Safety Incidence of AEs and SAEs, treatment discontinuation due to TEAEs, rate of dose reduction due to TEAEs, rate of dose delays due to TEAEs, change from baseline in vital signs, haematology, clinical chemistry, and urinalysis laboratory results, and ECGs. Main Phase III study Radiographic Progression-Free Survival (rPFS) [Time Frame: From randomization until first radiographic progression per RECIST 1.1/PCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months)] rPFS is defined as the time from randomisation to radiographic progression, as assessed by the BICR per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause. Overall Survival (OS) [Time Frame: From randomization until death from any cause (up to approximately 33 months)] OS is defined as the length of time from randomisation until the date of death due to any cause. | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Finland, France, Germany, India, Italy, Japan, Netherlands, Poland, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed