AZD2265 plus standard care vs standard care in PSMA-positive metastatic castration-resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial randomizes about 670 adults with metastatic castration-resistant prostate cancer to receive AZD2265 (Actinium-225 labeled peptide) or the investigator’s choice of standard therapies (cabazitaxel, an AR pathway inhibitor, or radium-223). Treatment continues until disease progression, unacceptable toxicity, or other discontinuation criteria, with tumor assessments ongoing after end of treatment. An independent Data Monitoring Committee will monitor safety and integrity throughout the study. The trial evaluates radiographic PFS and overall survival as primary outcomes and includes follow-up for survival after treatment ends.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Dothan, Alabama, United States Recruiting
• Research Site
  Duarte, California, United States Recruiting
• Research Site
  Newport Beach, California, United States Recruiting
• Research Site
  San Francisco, California, United States Recruiting
• Research Site
  Miami, Florida, United States Recruiting
• Research Site
  Metairie, Louisiana, United States Recruiting

+101 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.