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VECTRA-01 Study for Metastatic Castration-Resistant Prostate Cancer

This study is testing a new drug called AZD2265 for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread to other parts of the body and is no longer responding to treatments that lower testosterone. Researchers want to see if AZD2265 works better than standard treatments like Cabazitaxel, Abiraterone, Enzalutamide, or Apalutamide. They will measure this by looking at how long you live without your cancer getting worse (radiographic progression-free survival) and how long you live overall. You might be able to join if you are at least 18, have prostate cancer that has spread and is resistant to hormone therapy, and have a metastatic lesion that can be measured. The study is currently recruiting about 670 participants.

Study design
This study will involve about 670 adult men who will be randomly assigned to receive either AZD2265 or a standard treatment chosen by their doctor. An Independent Data Monitoring Committee will oversee the safety and scientific integrity of the study.
What's involved
You will receive your assigned treatment until your disease gets worse, you experience side effects that are too difficult to manage, or other reasons for stopping treatment are met. Tumor evaluation scans will continue after treatment stops until your cancer progresses or you pass away.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for survival until the end of the study, which is expected to be up to approximately 33 months after randomization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07611110

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~670 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])CabazitaxelAbirateroneEnzalutamideApalutamideDarolutamide

At a glance

Recruiting sites
10 of 132 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic Progression-Free Survival (rPFS)
Measured over From randomization until first radiographic progression per RECIST 1.1/PCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months)
+1 more outcome measured

Conditions

Metastatic Castration-resistant Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

132 sites across 42 states
China20
Germany15
Japan12
Spain7
South Korea6
Israel5
Taiwan5
California4

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 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

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.

What this trial measures

  • Radiographic Progression-Free Survival (rPFS)From randomization until first radiographic progression per RECIST 1.1/PCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months)

    rPFS is defined as the time from randomisation to radiographic progression, as assessed by the BICR per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause.

  • Overall Survival (OS)From randomization until death from any cause (up to approximately 33 months)

    OS is defined as the length of time from randomisation until the date of death due to any cause.