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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)

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Metastatic Castration-resistant Prostate Cancer
Date of first enrollment	01/07/2026
Target sample size	40
Countries of recruitment	Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Finland,Japan,France,Japan,Germany,Japan,Austria,Japan,India,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	JAPAN SAFETY RUN-IN SUB-STUDY Drug: AZD2265 Main Phase 3 study Drug: AZD2265 Drug: Cabazitaxel Drug: Abiraterone Drug: Enzalutamide Drug: Radium-223

Outcome(s)

Primary Outcome

JAPAN SAFETY RUN-IN SUB-STUDY Safety Incidence of AEs and SAEs, treatment discontinuation due to TEAEs, rate of dose reduction due to TEAEs, rate of dose delays due to TEAEs, change from baseline in vital signs, haematology, clinical chemistry, and urinalysis laboratory results, and ECGs. Main Phase III study Radiographic Progression-Free Survival (rPFS) [Time Frame: 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)] 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. Overall Survival (OS) [Time Frame: From randomization until death from any cause (up to approximately 33 months)] OS is defined as the length of time from randomisation until the date of death due to any cause.

Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender
Include criteria	- 18 years of age or more. - 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 Beta-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.
Exclude criteria	- Prior treatment with an alpha-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted). - Progression on PSMA-directed Beta-emitting radioconjugate prior to the administration of Cycle 3. - Receipt of > 6 cycles of PSMA-directed Beta-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.