Trial comparing treatments for Metastatic Castration-resistant Prostate Cancer
Official title AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
ClinicalTrials.gov ID: NCT07611110
What this study is testing
What is Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])?
Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]) is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Also referred to as AZD2265, FPI-2265.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if AZD2265 can improve radiographic progression‑free survival and overall survival compared with usual treatments.
- Who it's for
- Men who have PSMA‑positive metastatic castration‑resistant prostate cancer.
- What's involved
- Participants will be given either AZD2265 or the standard therapy and will undergo regular scans and check‑ups to track cancer growth and health.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- ≥ 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...
- Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.
You likely can't join if
- 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...
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Dothan, Alabama, United States
- Duarte, California, United States
- Newport Beach, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Metairie, Louisiana, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Melbourne, Australia
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Fukuoka, Japan
- Kanazawa, Japan
- Sapporo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dothan, Alabama, United States; Duarte, California, United States; Newport Beach, California, United States; San Francisco, California, United States; Miami, Florida, United States; Metairie, Louisiana, United States and 12 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.