Metastatic Castration-resistant Prostate CancerPhase 3VECTRA-01NCT07611110
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
A Phase 3 study testing Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]), Cabazitaxel and Abiraterone in people with Metastatic Castration-resistant Prostate Cancer, run by AstraZeneca at 151 sites in 24 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]), Cabazitaxel and Abiraterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 670 participants
- Where
- 151 sitesin 24 countries
- Study dates
- 4 May 2026to 6 Jun 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
151 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
151 sites in 24 countries
United States28 sites, 25 recruiting
- Not yet recruiting
Research Site
Albuquerque, New Mexico, 87109
- Not yet recruiting
Research Site
Aurora, Colorado, 80045
- Not yet recruiting
Research Site
Cleveland, Ohio, 44115
- Not yet recruiting
Research Site
Cleveland, Ohio, 44195
- Not yet recruiting
Research Site
Dayton, Ohio, 45415
- Withdrawn
Research Site
Detroit, Michigan, 48201
- Recruiting
Research Site
Dothan, Alabama, 36303
- Recruiting
Research Site
Duarte, California, 91010
- Not yet recruiting
Research Site
Grand Rapids, Michigan, 49503
- Recruiting
Research Site
Houston, Texas, 77042
- Not yet recruiting
Research Site
Irvine, California, 92618
- Recruiting
Research Site
Metairie, Louisiana, 70006
- Recruiting
Research Site
Miami, Florida, 33165
- Recruiting
Research Site
Myrtle Beach, South Carolina, 29572
- Recruiting
Research Site
Nashville, Tennessee, 37203
- Not yet recruiting
Research Site
New Hyde Park, New York, 11042
- Recruiting
Research Site
New York, New York, 10065
- Recruiting
Research Site
Newport Beach, California, 92660
- Not yet recruiting
Research Site
O'Fallon, Illinois, 62269
- Recruiting
Research Site
Omaha, Nebraska, 68130
- Withdrawn
Research Site
Phoenix, Arizona, 85004
- Recruiting
Research Site
Pittsburgh, Pennsylvania, 15232
- Not yet recruiting
Research Site
Portland, Oregon, 97239
- Suspended
Research Site
Salt Lake City, Utah, 84106
- Recruiting
Research Site
San Francisco, California, 94143
- Not yet recruiting
Research Site
St Louis, Missouri, 63104
- Not yet recruiting
Research Site
Tacoma, Washington, 98405
- Not yet recruiting
Research Site
Westbrook, Maine, 04092
China21 sites, 20 recruiting
- Not yet recruiting
Research Site
Beijing, 100034
- Not yet recruiting
Research Site
Beijing, 100142
- Not yet recruiting
Research Site
Chengdu, 610041
- Not yet recruiting
Research Site
Chongqing, 400030
- Not yet recruiting
Research Site
Fuzhou, 350005
- Not yet recruiting
Research Site
Guangzhou, 510060
- Not yet recruiting
Research Site
Guangzhou, 510120
- Not yet recruiting
Research Site
Guangzhou, 510630
- Not yet recruiting
Research Site
Hangzhou, 310003
- Not yet recruiting
Research Site
Hangzhou, 310014
- Not yet recruiting
Research Site
Hangzhou, 310022
- Not yet recruiting
Research Site
Jinan, 250117
- Not yet recruiting
Research Site
Nanjing, 210006
- Suspended
Research Site
Nanjing, 210029
- Not yet recruiting
Research Site
Shanghai, 200025
- Not yet recruiting
Research Site
Shanghai, 200032
- Not yet recruiting
Research Site
Shenyang, 110001
- Not yet recruiting
Research Site
Suzhou, 215006
- Not yet recruiting
Research Site
Wuhan, 430022
- Not yet recruiting
Research Site
Wuhan, 430030
- Not yet recruiting
Research Site
Xi'an, 710061
Germany15 sites, 13 recruiting
- Not yet recruiting
Research Site
Augsburg, 86156
- Not yet recruiting
Research Site
Berlin, 13353
- Not yet recruiting
Research Site
Bonn, 53127
- Not yet recruiting
Research Site
Cologne, 50937
- Not yet recruiting
Research Site
Dresden, 01307
- Not yet recruiting
Research Site
Essen, 45122
- Not yet recruiting
Research Site
Jena, 07747
- Withdrawn
Research Site
Karlsruhe, 76133
- Not yet recruiting
Research Site
München, 81675
- Not yet recruiting
Research Site
Münster, 48149
- Withdrawn
Research Site
Nuremberg, 90419
- Not yet recruiting
Research Site
Rostock, 18057
- Not yet recruiting
Research Site
Stuttgart, 70174
- Not yet recruiting
Research Site
Tübingen, 72076
- Not yet recruiting
Research Site
Würzburg, 97080
Japan12 sites, 12 recruiting
- Not yet recruiting
Research Site
Chiba, 260-8717
- Not yet recruiting
Research Site
Chūōku, 104-0045
- Recruiting
Research Site
Fukuoka, 812-8582
- Not yet recruiting
Research Site
Hamamatsu, 431-3192
- Not yet recruiting
Research Site
Kamakura-shi, 247-8533
- Recruiting
Research Site
Kanazawa, 920-8641
- Not yet recruiting
Research Site
Kashiwa, 227-8577
- Not yet recruiting
Research Site
Kobe, 650-0047
- Not yet recruiting
Research Site
Kyoto, 606-8507
- Recruiting
Research Site
Sapporo, 060-8638
- Not yet recruiting
Research Site
Suita-shi, 565-0871
- Not yet recruiting
Research Site
Yokohama, 236-0004
Canada7 sites, 7 recruiting
- Not yet recruiting
Research Site
Edmonton, Alberta, T6G 1Z2
- Not yet recruiting
Research Site
Halifax, Nova Scotia, B3H 1V7
- Not yet recruiting
Research Site
Hamilton, Ontario, L8V 1C3
- Recruiting
Research Site
Montreal, Quebec, H3A 1A1
- Recruiting
Research Site
Montreal, Quebec, H3T 1E2
- Recruiting
Research Site
Toronto, Ontario, M4N 3M5
- Not yet recruiting
Research Site
Toronto, Ontario, M5G 2M9
Italy7 sites, 7 recruiting
- Not yet recruiting
Research Site
Milan, 20133
- Not yet recruiting
Research Site
Milan, 20141
- Not yet recruiting
Research Site
Misterbianco, 95045
- Not yet recruiting
Research Site
Naples, 80131
- Not yet recruiting
Research Site
Negrar, 37024
- Not yet recruiting
Research Site
Reggio Emilia, 422122
- Not yet recruiting
Research Site
Rozzano, 20089
Spain7 sites, 7 recruiting
- Not yet recruiting
Research Site
Barcelona, 08025
- Not yet recruiting
Research Site
Barcelona, 8035
- Not yet recruiting
Research Site
L'Hospitalet de Llobregat, 08908
- Not yet recruiting
Research Site
Madrid, 28041
- Not yet recruiting
Research Site
Majadahonda, 28222
- Not yet recruiting
Research Site
Málaga, 29009
- Not yet recruiting
Research Site
Santiago de Compostela, 15706
South Korea6 sites, 6 recruiting
- Not yet recruiting
Research Site
Goyang-si, 10408
- Not yet recruiting
Research Site
Seoul, 03080
- Not yet recruiting
Research Site
Seoul, 06591
- Not yet recruiting
Research Site
Seoul, 3722
- Not yet recruiting
Research Site
Seoul, 5505
- Not yet recruiting
Research Site
Seoul, 6351
Israel5 sites, 5 recruiting
- Not yet recruiting
Research Site
Haifa, 3109601
- Not yet recruiting
Research Site
Jerusalem, 00000
- Not yet recruiting
Research Site
Petah Tikva, 4941492
- Not yet recruiting
Research Site
Ramat Gan, 52621
- Not yet recruiting
Research Site
Tel Aviv, 64239
Taiwan5 sites, 5 recruiting
- Not yet recruiting
Research Site
Kaohsiung City, 833401
- Not yet recruiting
Research Site
Taipei, 10002
- Not yet recruiting
Research Site
Taipei, 11217
- Not yet recruiting
Research Site
Taipei, 11259
- Not yet recruiting
Research Site
Taoyuan, 333
Australia4 sites, 4 recruiting
- Not yet recruiting
Research Site
Darlinghurst, 2010
- Not yet recruiting
Research Site
Kurralta Park, 5037
- Recruiting
Research Site
Melbourne, 3000
- Not yet recruiting
Research Site
Murdoch, WA6150
India4 sites, 4 recruiting
- Not yet recruiting
Research Site
Bangalore, 560017
- Not yet recruiting
Research Site
Gūrgaon, 122001
- Not yet recruiting
Research Site
Gūrgaon, 122002
- Not yet recruiting
Research Site
Navi Mumbai, 410210
Turkey (Türkiye)4 sites, 4 recruiting
- Not yet recruiting
Research Site
Ankara, 06530
- Not yet recruiting
Research Site
Ankara, 06620
- Not yet recruiting
Research Site
Istanbul, 34098
- Not yet recruiting
Research Site
Istanbul, 34752
United Kingdom4 sites, 4 recruiting
- Not yet recruiting
Research Site
London, EC1A 7BE
- Not yet recruiting
Research Site
Middlesbrough, TS4 3BW
- Not yet recruiting
Research Site
Southampton, SO16 6YD
- Not yet recruiting
Research Site
Truro, TR1 3LJ
Austria3 sites, 3 recruiting
- Not yet recruiting
Research Site
Linz, 4020
- Not yet recruiting
Research Site
Salzburg, 5020
- Not yet recruiting
Research Site
Vienna, 1090
Belgium3 sites, 3 recruiting
- Not yet recruiting
Research Site
Ghent, 9000
- Not yet recruiting
Research Site
Leuven, 3000
- Not yet recruiting
Research Site
Liège, 4000
Poland3 sites, 2 recruiting
- Not yet recruiting
Research Site
Gdansk, 80-214
- Suspended
Research Site
Krakow, 31-501
- Not yet recruiting
Research Site
Warsaw, 02-781
Switzerland3 sites, 3 recruiting
- Not yet recruiting
Research Site
Bern, 3010
- Not yet recruiting
Research Site
Geneva, 1205
- Not yet recruiting
Research Site
Zurich, 8091
Brazil2 sites, 2 recruiting
- Not yet recruiting
Research Site
São Paulo, 01308-050
- Not yet recruiting
Research Site
São Paulo, 05652-900
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Research Site
Amsterdam, 1066CX
- Not yet recruiting
Research Site
Nijmegen, 6525 GA
Sweden2 sites, 2 recruiting
- Not yet recruiting
Research Site
Stockholm, 17176
- Not yet recruiting
Research Site
Umeå, 901 85
Thailand2 sites, 2 recruiting
- Not yet recruiting
Research Site
Bangkok, 10210
- Not yet recruiting
Research Site
Bangkok, 10700
About this study
Official title: 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)
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.
Read the detailed description
Approximately 670 adult participants with mCRPC will be randomized to receive either AZD2265 or standard of care treatment (investigator's choice of cabazitaxel, ARPI, or radium-223). They will receive their assigned treatment until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Tumor evaluation scans will continue after treatment discontinuation until radiographically confirmed progression or death.
All patients will be followed for survival until the end of the study. An Independent Data Monitoring Committee (IDMC) composed of independent experts will be convened to monitor the safety and scientific integrity of the study.
- Being tested
- Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]), Cabazitaxel, Abiraterone, Enzalutamide, Apalutamide
- Keywords
- AZD2265; prostate cancer; mCRPC; PSMA; FPI-2265; 225Ac; Actinium (225Ac) zadavotide guraxetan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])Drug
Also called AZD2265, FPI-2265
IV
CabazitaxelDrug
Also called Jevtana
IV in combination with oral prednisone/prednisolone
AbirateroneDrug
Also called Zytiga
Oral in combination with prednisone/prednisolone
EnzalutamideDrug
Also called Xtandi
Oral
ApalutamideDrug
Also called Erleada
Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)
DarolutamideDrug
Also called Nubeqa
Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)
DeutenzalutamideDrug
Oral; available in China only
Radium-223Drug
Also called Xofigo
IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]) Receives: Drug: Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]) |
| Arm B | Active comparator | Investigator's choice of cabazitaxel, ARPI, or radium-223 Receives: Drug: Cabazitaxel; Drug: Abiraterone; Drug: Enzalutamide; Drug: Apalutamide; Drug: Darolutamide; Drug: Deutenzalutamide; Drug: Radium-223 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Overall Survival (OS)
OS is defined as the length of time from randomisation until the date of death due to any cause.
Measured: From randomization until death from any cause (up to approximately 33 months)
Secondary outcomes (7)
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.
Measured: 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)
Assessment of PSA50 (≥50% prostate-specific antigen reduction)
Proportion of participants achieving a >= 50% decrease in PSA from baseline.
Measured: 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)
Assessment of PSA90 (≥90% prostate-specific antigen reduction)
Proportion of participants achieving >=90% decrease in PSA from baseline.
Measured: 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)
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).
Measured: 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)
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone) as determined by BICR or death in the absence of disease progression.
Measured: From first documented response until progression per RECIST 1.1/PCWG3 by BICR, or death in the absence of progression, whichever occurs first (up to approximately 33 months)
Symptomatic Skeletal Event-Free Survival (SSE-FS)
SSE-FS is defined as the time from randomisation to the earliest of the following:
- Use of radiation therapy to prevent or relieve skeletal symptoms.
- Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).
- Occurrence of spinal cord compression.
- Orthopaedic surgical intervention for bone metastasis.
- Death due to any cause.
Measured: From randomization until first symptomatic skeletal event or death from any cause, whichever occurs first (up to approximately 33 months)
Plasma concentrations of AZD2265
Plasma concentrations of AZD2265 pre-dose and post-dose.
Measured: Pre-dose and post-dose on Day 1 of Cycles 1 and 2; 3-24 hours post-dose on Cycle 1 Day 1 only (up to approximately 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start4 May 2026
- Primary completion4 Jun 2029 (estimated)
- Study completion6 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to receive either AZD2265 or standard of care treatment (investigator's choice of cabazitaxel, ARPI, or radium-223).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611110
- Sponsor's protocol ID
- D9735C00001
- Acronym
- VECTRA-01
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.