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RecruitingPhase 3

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

A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares AZD2265 with standard treatments for prostate cancer that has spread and keeps growing despite very low testosterone levels. It is for people whose scans show a protein called PSMA on their cancer. The study tests whether AZD2265 helps people live longer and delays cancer growth seen on scans.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older with prostate adenocarcinoma, a type of prostate cancer.
  • Have had surgery to remove the testicles, are taking treatment to lower testosterone, or both, and have very low testosterone.
  • Cancer has spread and worsened after the latest treatment, with at least one cancer spot that can be checked again with scans.
  • Have had at least 2 cycles of PSMA-targeted treatment that delivers beta radiation to cancer.
  • Have had at least one taxane chemotherapy treatment and at least one ARPI, a drug that blocks male hormones or their effects.
  • Have a positive PSMA PET/CT scan using one of the study-approved scan agents.
  • Can do all or most daily self-care, and have organs and bone marrow working well enough for the study.
  • Must use condoms with all sexual partners, not father children, and not donate sperm from signing consent until 6 months after the last study dose.

Who can't join

  • Past treatment with a targeted drug that delivers alpha radiation. Past radium-223 treatment is allowed.
  • Cancer worsened before cycle 3 of PSMA-targeted beta radiation treatment.
  • Have had more than 6 cycles of PSMA-targeted beta radiation treatment.
  • History of another cancer, with some exceptions.
  • Ongoing moderate or worse side effects from past cancer treatment, with some exceptions.
  • Pressure on the spinal cord or cancer spread to the brain, unless stable, causing no symptoms, and not needing steroids for at least 4 weeks before study treatment.
  • Important problems on an ECG, a test of the heart’s electrical activity, with some exceptions.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (28)

AL

AZ

CA

CO

FL

IL

LA

ME

MI

MO

NE

NM

NY

OH

OR

PA

SC

TN

TX

UT

WA