Study Comparing AZD2265 with Standard Treatments for PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07611110

Provider View

This clinical trial is testing whether the new drug AZD2265 is more effective than standard treatments in improving survival and delaying cancer progression in patients with advanced prostate cancer that has spread and is resistant to hormone therapy.

Patient Parameters

Program Overview

The study aims to find out if AZD2265 can help patients with advanced prostate cancer live longer and delay the progression of their cancer compared to standard treatments. Participants will be randomly assigned to receive either AZD2265 or a standard treatment chosen by their doctor, which could include cabazitaxel, a switch in hormone therapy, or radium-223. Treatment will continue until the cancer worsens, side effects become unacceptable, or other reasons for stopping arise. Even after stopping treatment, patients will have regular scans to monitor their cancer until it progresses or they pass away. An independent committee will oversee the study to ensure safety and accuracy.

Description

In this study, about 670 adults with advanced prostate cancer that has spread and is resistant to hormone therapy will participate. They will be randomly assigned to receive either the new drug AZD2265 or a standard treatment chosen by their doctor. The standard treatments could include chemotherapy with cabazitaxel, a change in hormone therapy, or treatment with radium-223. Participants will continue their assigned treatment until their cancer progresses, they experience unacceptable side effects, or other criteria for stopping treatment are met. After stopping treatment, participants will continue to have regular scans to monitor their cancer until it progresses or they pass away. The study will be monitored by an independent committee of experts to ensure the safety and scientific integrity of the research.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a diagnosis of prostate cancer.
  • Must have had surgery to remove the testicles or be on ongoing hormone therapy with low testosterone levels.
  • Cancer must have progressed after the most recent treatment, with at least one area of cancer that can be measured by scans.
  • Previously treated with at least two cycles of a specific type of cancer treatment targeting PSMA.
  • Previously treated with at least one chemotherapy regimen for prostate cancer.
  • Previously treated with at least one hormone therapy drug like enzalutamide or abiraterone.
  • Must have positive PSMA PET/CT scans.
  • Must be in relatively good health with a performance status score between 0 and 2.
  • Must have adequate organ and bone marrow function.
  • Must agree not to father children or donate sperm during the study and for six months after the last dose.
  • Must use a condom during the study and for six months after the last dose with all sexual partners.

Exclusion Criteria

  • Cannot have had prior treatment with a specific type of targeted radiotherapy, except for radium-223.
  • Cannot have had cancer progression on a specific type of PSMA-targeted treatment before the third cycle.
  • Cannot have received more than six cycles of a specific PSMA-targeted treatment.
  • Cannot have a history of another primary cancer, with some exceptions.
  • Cannot have ongoing side effects from previous cancer treatments, with some exceptions.
  • Cannot have spinal cord compression or brain metastases unless they are stable and not requiring steroids for at least four weeks before starting the study.
  • Cannot have significant heart rhythm abnormalities, with some exceptions.

Locations

FACILITYZIPCITYSTATE
Research Site36303DothanAlabama
Research Site85004PhoenixArizona
Research Site92618IrvineCalifornia
Research Site92354Loma LindaCalifornia
Research Site94143San FranciscoCalifornia
Research Site80045AuroraColorado
Research Site33165MiamiFlorida
Research Site62269O'FallonIllinois
Research Site70006MetairieLouisiana
Research Site48201DetroitMichigan

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