ProBio: An outcome-adaptive and randomised multi-arm biomarker driven study in patients with metastatic prostate cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506857-40-00

Enrollment

1750

Registered

2024-06-25

Start date

2019-01-08

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

Progression-free survival, where progression is defined according to disease stage at trial entry: ● For mHSPC: Time to development of castration-resistance (European Association of Urology [EAU] guidelines) or death ● For mCRPC: Time to no longer clinical benefiting (NLCB) (Prostate Cancer Working Group [PCWG3] guidelines)

Detailed description

1.Overall survival (OS). 2. Quality of life assessed by In all patients enrolled in ProBio: ● EORTC-QLQ-C30 ● EQ-5D-5L ● BPI-SF In patients enrolled in ProBio with ctDNA-undetectable mHSPC: EORTC QLQ-PR25 (hormonal and sexual subdomains). 3. Cost effectiveness will be assessed by using the EQ-5D-5L instrument to estimate health utilities. Treatment costs will be based on drug costs and reimbursement data. 4. Frequency and severity of adverse events (AE).

Interventions

DRUGNUBEQA 300 mg film-coated tablets

DRUGNiraparib tosylate monohydrate + abiraterone acetate - Film coated tablet- 79.90 mg (eq. 50mg base)+ 500mg

DRUGABIRATERONE ACETATE

DRUGRADIUM (223RA) DICHLORIDE

DRUGCapivasertib

DRUGBAY 1841788

DRUGABIRATERONE

DRUGENZALUTAMIDE

DRUGAPALUTAMIDE

DRUGNiraparib tosylate monohydrate+ abiraterone acetate - Film coated tablet- 159.40 mg (eq. 100mg base)+ 500mg

DRUGDOCETAXEL

DRUGDAROLUTAMIDE

DRUGOLAPARIB

DRUGCABAZITAXEL

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival, where progression is defined according to disease stage at trial entry: ● For mHSPC: Time to development of castration-resistance (European Association of Urology [EAU] guidelines) or death ● For mCRPC: Time to no longer clinical benefiting (NLCB) (Prostate Cancer Working Group [PCWG3] guidelines)	—

Secondary

Measure	Time frame
1.Overall survival (OS). 2. Quality of life assessed by In all patients enrolled in ProBio: ● EORTC-QLQ-C30 ● EQ-5D-5L ● BPI-SF In patients enrolled in ProBio with ctDNA-undetectable mHSPC: EORTC QLQ-PR25 (hormonal and sexual subdomains). 3. Cost effectiveness will be assessed by using the EQ-5D-5L instrument to estimate health utilities. Treatment costs will be based on drug costs and reimbursement data. 4. Frequency and severity of adverse events (AE).	—

Measure

Time frame

—

Countries

Belgium, Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026