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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants are randomized to receive either AZD2265 or standard of care treatment (investigator's choice of cabazitaxel, ARPI switch, or radium-223).
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Open-label

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A 		AZD2265
  • Drug: AZD2265
    IV
    Other names:
    • FPI-2265
Active Comparator
Arm B 		Investigator's choice of cabazitaxel, ARPI switch, or radium-223
  • Drug: Cabazitaxel
    IV in combination with oral prednisone/prednisolone
    Other names:
    • Jevtana
  • Drug: Abiraterone
    Oral in combination with prednisone/prednisolone
    Other names:
    • Zytiga
  • Drug: Enzalutamide
    Oral
    Other names:
    • Xtandi
  • Drug: Apalutamide
    Oral
    Other names:
    • Erleada
  • Drug: Darolutamide
    Oral
    Other names:
    • Nubeqa
  • Drug: Rezvilutamide
    Oral
    Other names:
    • Ariane
  • Drug: Radium-223
    IV
    Other names:
    • Xofigo

Recruiting Locations

Research Site
Miami, Florida 33165

Research Site
Omaha, Nebraska 68130

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

Detailed Description

Approximately 670 adult participants with mCRPC will be randomized to receive either AZD2265 or standard of care treatment (investigator's choice of cabazitaxel, ARPI switch, or radium-223). They will receive their assigned treatment until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Tumor evaluation scans will continue after treatment discontinuation until radiographically confirmed progression or death. All patients will be followed for survival until the end of the study. An Independent Data Monitoring Committee (IDMC) composed of independent experts will be convened to monitor the safety and scientific integrity of the study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.