ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

  • Recruiting
  • Treatment
  • Interventional
  • Randomized
  • Drug
  • PHASE3
  • Karolinska Institutet
  • 18 Years -


Study Purpose

ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer. Patients will be randomized to control or experimental treatment arms. Patients in the control arm will receive standard of care following national guidelines. Patients in the experimental arm will be randomized to treatments based on a biomarker signature inferred from diagnostic tissue or liquid biopsy profiling. The predefined biomarker signatures are tumor properties or mutations in genes/pathways with previously demonstrated clinical validity (e.g. prognostic value or association with treatment response). The biomarker signatures are identified using a hybridisation capture gene panel specifically designed for prostate cancer.

Intervention

Drug : Enzalutamide Oral Capsule

Drug : Abiraterone Oral Tablet

Drug : Carboplatin

Drug : Cabazitaxel 60 mg Solution for Injection

Drug : Docetaxel Injectable Solution

Drug : Radium Chloride Ra-223

Drug : Niraparib plus Abiraterone acetate plus Prednisone

Drug : Capivasertib plus Docetaxel

Drug : Apalutamide

Drug : Darolutamide


Eligibility Requirements

info icon Man with histologically confirmed prostate adenocarcinoma, initiating systemic therapy for metastatic disease, encompassing newly diagnosed (i.e. de novo) hormone sensitive prostate cancer (mHSPC) or first-line castration resistant prostate cancer (mCRPC)

info icon Distant metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI

info icon Adequate health as assessed by the investigator to receive all available treatments in the trial

info icon ECOG/WHO (Eastern Cooperative Oncology Group/ World Health Organization) performance score 0-2

info icon Adequate organ and bone marrow function

info icon Albumin greater than or equal to 28 g/L

info icon Able to understand the patient information and sign written informed consent

info icon Minimum age: 18

info icon Other malignancies within 5 years except non-melanoma skin cancer

info icon Within 6 months of randomization: myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke, TIA (transient ischemic attack), or congestive heart failure NYHA (New York Heart Association) class III or IV

info icon Uncontrolled hypertension

info icon Uncontrolled hypotension

info icon Received systemic therapy (with the exception of standard ADT) prior to study inclusion, for the CRPC indication

info icon Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results

info icon Unable to comply with study procedures

info icon Current participation in another clinical trial that will be in conflict with the present study, administration of an investigational therapeutic or invasive surgical procedure within 28 days prior to study enrolment

info icon Patients who are unlikely to comply with the protocol

info icon Any condition or situation which, in the opinion of the investigator, would put the subject at risk, may confound study results, or interfere with the subjects participation in this study.

info icon Any medical condition that would make use of the study treatments contraindicated, according to the SmPC, e.g. significant heart or liver disease.

Recruiting status

Recruiting

Estimated enrollment

750

 
Study start date

Feb 01, 2019

Study end date

Dec 31, 2026

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE3

Allocation

Randomized

 

Sponsor:

Karolinska Institutet

Collaborator:

The Swedish Research Council

Kom Op Tegen Kanker

Janssen Pharmaceutica N.V., Belgium

AstraZeneca

Cancerfonden

Investigator:

Henrik Grönberg, Professor

Martin Eklund, Professor

Johan Lindberg, PhD

Piet Ost, Professor

Jan Oldenburg, Professor

Ashkan Mortezavi, MD, PhD

NCT03903835

Clinic Location Investigator Distance RECRUITING STATUS Contact