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

PHASE3RecruitingINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

February 1, 2019

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

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).

Trial Locations (32)

17176

RECRUITING

Karolinska University Hospital, Stockholm

75185

RECRUITING

Akademiska sjukhuset, Uppsala

79182

RECRUITING

Falu lasarett, Falun

90185

RECRUITING

Norrlands Universitetssjukhus, Umeå

Unknown

RECRUITING

OLV Ziekenhuis Aalst, Aalst

RECRUITING

GZA Sint-Augustinus, Antwerp

RECRUITING

AZ Sint-Lucas, Bruges

RECRUITING

Ziekenhuis Oost-Limburg, Genk

NOT_YET_RECRUITING

AZ Jan Palfijn Ziekenhuis, Ghent

RECRUITING

Jessa ziekenhuis, Hasselt

RECRUITING

AZ Groeninge, Kortrijk

RECRUITING

University Hospital Luik, Liège

RECRUITING

AZ Damiaan, Ostend

RECRUITING

VITAZ, Sint-Niklaas

NOT_YET_RECRUITING

Ålesund Sjukehus, Ålesund

RECRUITING

Kreftsenter Kristiansand, Kristiansand

RECRUITING

Akershus Universitetssykehus, Lørenskog

RECRUITING

Stavanger Universitetssjukehus, Stavanger

NOT_YET_RECRUITING

Universitetssykehuset Nord-Norge Tromsö, Tromsø

RECRUITING

Södra Alvsborgs sjukhus, Borås

RECRUITING

Universitetssjukhuset Örebro, Örebro

RECRUITING

Capio St.Görans Hospital, Stockholm

RECRUITING

Hallands sjukhus Varberg, Varberg

RECRUITING

St. Claraspital, Basel

RECRUITING

Universitätsspital Basel, Basel

B-8000

RECRUITING

AZ Sint-Jan AV, Bruges

B-9000

RECRUITING

University Hospital Ghent, Ghent

551 11

RECRUITING

Länssjukhuset Ryhov - Onkologiska kliniken, Jönköping

392 44

RECRUITING

Länssjukhuset, Kalmar

651 85

RECRUITING

Centralsjukhuset Region Värmland, Karlstad

851 86

RECRUITING

Länssjukhuset Sundsvall Härnösand, Sundsvall

351 85

RECRUITING

Centrallasarettet Onkologkliniken, Vaxjo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

The Swedish Research Council

OTHER_GOV

collaborator

Kom Op Tegen Kanker

OTHER

collaborator

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

collaborator

AstraZeneca

INDUSTRY

collaborator

Cancerfonden

UNKNOWN

lead

Karolinska Institutet

OTHER

NCT03903835 - ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer | Biotech Hunter | Biotech Hunter