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AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

NCT07611110

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Metastatic Castration-resistant Prostate Cancer

Interventions: AZD2265, Cabazitaxel, Abiraterone, Enzalutamide, Apalutamide

Countries: United States, Australia, Austria, Brazil, Canada, China, France, Germany

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.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (104)
  • Dothan, Alabama, United States
  • Phoenix, Arizona, United States
  • Duarte, California, United States
  • Irvine, California, United States
  • Newport Beach, California, United States
  • San Francisco, California, United States
  • Aurora, Colorado, United States
  • Miami, Florida, United States
  • O'Fallon, Illinois, United States
  • Metairie, Louisiana, United States
  • Detroit, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Omaha, Nebraska, United States
  • Albuquerque, New Mexico, United States
  • New Hyde Park, New York, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Dayton, Ohio, United States
  • Portland, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Myrtle Beach, South Carolina, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Tacoma, Washington, United States
  • Darlinghurst, Australia
  • Melbourne, Australia
  • Linz, Austria
  • Salzburg, Austria
  • São Paulo, Brazil
  • + 74 more on CT.gov