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

Summary

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.

Conditions

• Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Interventions

DRUG

Enzalutamide Oral Capsule

Detailed conditions for the use of the study treatments including dose and dosages are described in accordance with the marketing authorization in the SmPC (Summary of Product Characteristics).

DRUG

Abiraterone Oral Tablet

Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.

DRUG

Carboplatin

Carboplatin will be administered every 3rd week with an AUC (area under curve) = 5 with a dose calculated according to the Carboplatin AUC Dose calculation (Calvert formula):Dose (mg) = TargetAUC (mg/ml x min) x \[GFR ml/min + 25\].

DRUG

Cabazitaxel 60 mg Solution for Injection

Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.

DRUG

Docetaxel Injectable Solution

Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.

DRUG

Radium Chloride Ra-223

Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.

DRUG

Niraparib plus Abiraterone acetate plus Prednisone

Niraparib and Abiraterone acetate will be provided by Janssen and will be provided either as a fixed dose combination or as single agents. Detailed use of the study treatment including dose and dosages are described in the Investigator's brochures and SmPC.

DRUG

Capivasertib plus Docetaxel

Capivasertib is provided by AstraZeneca and will be given in combination with Docetaxel. All subjects will be given up to ten 21-day docetaxel cycles. All subjects will receive Capivasertib, which will be administered as tablets taken twice a day orally, on a 4 days on/3 days off continuous schedule, commencing cycle one, day 2, until disease progression.

DRUG

Apalutamide

Detailed conditions for the use of the study treatments including dose and dosages are described in accordance with the marketing authorization in the SmPC (Summary of Product Characteristics).

DRUG

Darolutamide

Detailed conditions for the use of the study treatments including dose and dosages are described in accordance with the marketing authorization in the SmPC (Summary of Product Characteristics).

Sponsors & Collaborators

• The Swedish Research Council

  collaborator OTHER_GOV

• Kom Op Tegen Kanker

  collaborator OTHER

• Janssen Pharmaceutica N.V., Belgium

  collaborator INDUSTRY

• AstraZeneca

  collaborator INDUSTRY

• Cancerfonden

  collaborator UNKNOWN

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Henrik Grönberg, Professor · Karolinska Institutet

• Martin Eklund, Professor · Karolinska Institutet

• Johan Lindberg, PhD · Karolinska Institutet

• Piet Ost, Professor · University Hospital Ghent, Belgium

• Jan Oldenburg, Professor · University Hospital, Akershus

• Ashkan Mortezavi, MD, PhD · University Hospital, Basel, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-01

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Belgium
• Norway
• Sweden
• Switzerland

Study Locations