670 Participants NeededMy employer runs this trial

AZD2265 for Prostate Cancer

(VECTRA-01 Trial)

Recruiting at 106 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Male
Trial Phase: Phase 3
Sponsor: AstraZeneca
Must be taking: ADT, ARPI
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, AZD2265, for prostate cancer that has spread and is resistant to standard hormone therapy (mCRPC). The goal is to determine if AZD2265 can extend patients' lives and slow cancer spread compared to treatments like cabazitaxel, a switch in androgen receptor pathway inhibitor (ARPI), or radium-223. Men diagnosed with prostate cancer who have tried hormone therapy but still experience cancer progression might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing patients an opportunity to access a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown promising safety results for AZD2265 in patients with prostate cancer. Research indicates that this treatment is generally well-tolerated, even for those with extensive prior treatments. Most participants did not experience serious side effects. The safety data, derived from studies involving nearly 500 patients, supports further research. Overall, the findings suggest that AZD2265 is a safe option for those considering participation in a clinical trial.12345

Why do researchers think this study treatment might be promising for prostate cancer?

Unlike the standard prostate cancer treatments like chemotherapy and hormone therapy, AZD2265 offers a novel approach by targeting specific proteins involved in cancer cell growth. Researchers are excited about AZD2265 because it acts on a different pathway compared to existing drugs, which may provide better outcomes for patients who have not responded well to current therapies. This innovative mechanism could lead to more effective and personalized treatment options for prostate cancer patients, potentially reducing side effects and improving quality of life.

What evidence suggests that AZD2265 might be an effective treatment for prostate cancer?

Research has shown that AZD2265, which participants in this trial may receive, may help treat advanced prostate cancer unresponsive to hormone therapy. In earlier studies, about 33% of patients experienced tumor shrinkage, while 44% saw their cancer remain stable. Encouragingly, AZD2265 demonstrated an overall survival rate of 81%, with patients living without cancer progression for an average of 12 months. These findings suggest that AZD2265 might effectively slow down or reduce prostate cancer progression.13456

Are You a Good Fit for This Trial?

This trial is for people with advanced prostate cancer (metastatic castration-resistant) that shows up on a special PSMA scan. Participants should be adults whose cancer has continued to grow despite hormone therapy.

Inclusion Criteria

Positive PSMA PET/CT scans obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL)
Participants must use a condom from signing ICF during study intervention and for 6 months after last dose with all sexual partners
I have had my testicles removed or am on hormone therapy lowering my testosterone.
See 9 more

Exclusion Criteria

Clinically significant ECG abnormalities with exceptions
My cancer got worse after PSMA-targeted radioconjugate treatment.
I do not have symptoms from spinal cord or brain tumors and have not needed steroids recently.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AZD2265 or standard of care treatment until disease progression or unacceptable toxicity

Up to approximately 33 months
Visits every 8 weeks for the first 32 weeks, then every 12 weeks

Follow-up

Participants are monitored for survival and safety after treatment discontinuation

Until the end of the study

What Are the Treatments Tested in This Trial?

Interventions

  • AZD2265

Trial Overview

The study compares a new drug, AZD2265, against standard treatments like apalutamide, cabazitaxel, darolutamide, radium-223, abiraterone, enzalutamide, or rezvilutamide. Patients are randomly assigned to either the new drug or one of the standard options.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm AExperimental Treatment1 Intervention
Group II: Arm BActive Control7 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

Preliminary efficacy and safety results from the (TATCIST) trial ...

Preliminary efficacy and safety data as of 30Jan24 suggest that FPI-2265 is active in heavily pretreated pts with progressive mCRPC, including pts who received ...

PSMA-Directed Targeted Alpha Therapy Shows Activity in ...

Further, among those evaluable by RECIST 1.1 criteria (n = 9), 33% of patients achieved a partial response, 44% had stable disease, and 22% ...

Fusion Pharmaceuticals Announces Presentation of Interim ...

Preliminary data demonstrate FPI-2265 is active in heavily pretreated patients with progressive metastatic castration-resistant prostate cancer (mCRPC).

Preliminary efficacy and safety results from the TATCIST trial

A 72-year-old male with an 8-year history of prostate cancer (Gleason score 9) with extensive skeletal disease was enrolled into the TATCIST ...

FPI-2265 for Metastatic Prostate Cancer (AlphaBreak Trial)

The treatment also demonstrated promising overall survival rates of 81% and a median progression-free survival of 12 months, while maintaining low toxicity, ...

Study Details | NCT07611110 | AZD2265 Compared With ...

The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic ...