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

Recruiting · NCT07611110 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

AbirateroneActinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])Apalutamide Cabazitaxel DarolutamideDeutenzalutamideEnzalutamide Radium-223

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

Male

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 20 US states.

Research Site - Dothan, Alabama, United States
Research Site - Phoenix, Arizona, United States
Research Site - Duarte, California, United States
Research Site - Irvine, California, United States
Research Site - Newport Beach, California, United States
Research Site - San Francisco, California, United States
Research Site - Aurora, Colorado, United States
Research Site - Miami, Florida, United States
Research Site - O'Fallon, Illinois, United States
Research Site - Metairie, Louisiana, United States
Research Site - Detroit, Michigan, United States
Research Site - Grand Rapids, Michigan, United States
Research Site - St Louis, Missouri, United States
Research Site - Omaha, Nebraska, United States
Research Site - Albuquerque, New Mexico, United States
Research Site - New Hyde Park, New York, United States
Research Site - New York, New York, United States
Research Site - Cleveland, Ohio, United States
Research Site - Dayton, Ohio, United States
Research Site - Portland, Oregon, United States
Research Site - Pittsburgh, Pennsylvania, United States
Research Site - Myrtle Beach, South Carolina, United States
Research Site - Nashville, Tennessee, United States
Research Site - Houston, Texas, United States
Research Site - Salt Lake City, Utah, United States
Research Site - Tacoma, Washington, United States
Research Site - Ankara, Turkey (Türkiye)
Research Site - Ankara, Turkey (Türkiye)
Research Site - Augsburg, Germany
Research Site - Bangalore, India
Research Site - Bangkok, Thailand
Research Site - Bangkok, Thailand
Research Site - Barcelona, Spain
Research Site - Barcelona, Spain
Research Site - Beijing, China
Research Site - Beijing, China
Research Site - Berlin, Germany
Research Site - Bonn, Germany
Research Site - Chengdu, China
Research Site - Chiba, Japan
Research Site - Chongqing, China
Research Site - Chūōku, Japan
Research Site - Cologne, Germany
Research Site - Darlinghurst, Australia
Research Site - Dresden, Germany
Research Site - Essen, Germany
Research Site - Fukuoka, Japan
Research Site - Fuzhou, China
Research Site - Gdansk, Poland
Research Site - Goyang-si, South Korea
Research Site - Guangzhou, China
Research Site - Guangzhou, China
Research Site - Guangzhou, China
Research Site - Gurgaon, India
Research Site - Gurgaon, India
Research Site - Haifa, Israel
Research Site - Hamamatsu, Japan
Research Site - Hangzhou, China
Research Site - Hangzhou, China
Research Site - Hangzhou, China

Showing 60 of 132 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →