Condition: Metastatic Castration-resistant Prostate Cancer · Sponsor: AstraZeneca
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The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic progression-free survival (rPFS) and overall survival (OS) in participants with mCRPC.
This description comes directly from the study's public registry record.
AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * ≥ 18 years of age. * 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 β-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: * Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted). * Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3. * Receipt of \> 6 cycles of PSMA-directed β-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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Research Site | Dothan, Alabama, United States | Not Yet Recruiting |
| Research Site | Phoenix, Arizona, United States | Not Yet Recruiting |
| Research Site | Duarte, California, United States | Not Yet Recruiting |
| Research Site | Irvine, California, United States | Not Yet Recruiting |
| Research Site | Newport Beach, California, United States | Recruiting |
| Research Site | San Francisco, California, United States | Not Yet Recruiting |
| Research Site | Aurora, Colorado, United States | Not Yet Recruiting |
| Research Site | Miami, Florida, United States | Recruiting |
| Research Site | O'Fallon, Illinois, United States | Not Yet Recruiting |
| Research Site | Metairie, Louisiana, United States | Not Yet Recruiting |
| Research Site | Detroit, Michigan, United States | Withdrawn |
| Research Site | Grand Rapids, Michigan, United States | Not Yet Recruiting |
+ 92 more locations — full list on the registry record.
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