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

ConditionMetastatic Castration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorAstraZeneca

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])

    Drug

    IV

  • Cabazitaxel

    Drug

    IV in combination with oral prednisone/prednisolone

  • Abiraterone

    Drug

    Oral in combination with prednisone/prednisolone

  • Enzalutamide

    Drug

    Oral

  • Apalutamide

    Drug

    Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)

  • Darolutamide

    Drug

    Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)

  • Deutenzalutamide

    Drug

    Oral; available in China only

  • Radium-223

    Drug

    IV

Treatment groups

670 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BActive comparator 7 interventions

Trial outcomes

Primary outcomes

1

Radiographic Progression-Free Survival (rPFS)

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.

Time frame
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)
2

Overall Survival (OS)

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

Time frame
From randomization until death from any cause (up to approximately 33 months)

Secondary outcomes

1

Progression-Free Survival (PFS)

PFS is defined as the time from randomisation to the earliest of progression (defined as radiographic progression assessed by BICR per RECIST 1.1 and/or PCWG3 criteria, clinical progression, or PSA progression), or death due to any cause.

Time frame
From randomization until first documented progression (radiographic, clinical, or PSA progression) or death in the absence of progression, whichever occurs first (up to approximately 33 months)
2

Assessment of PSA50 (≥50% prostate-specific antigen reduction)

Proportion of participants achieving a \>= 50% decrease in PSA from baseline.

Time frame
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
3

Assessment of PSA90 (≥90% prostate-specific antigen reduction)

Proportion of participants achieving \>=90% decrease in PSA from baseline.

Time frame
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
4

Objective Response Rate (ORR)

ORR is defined as the proportion of participants with measurable soft tissue disease at baseline who have a CR or PR as determined by BICR, per RECIST 1.1 (soft tissue) and PCWG3 criteria (bone).

Time frame
From baseline; assessed by BICR per RECIST 1.1/PCWG3 every 8 weeks for first 32 weeks, then every 12 weeks until radiographic progression (up to approximately 33 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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