Actively Recruiting
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
Led by Karolinska Institutet · Updated on 2025-04-09
750
Participants Needed
32
Research Sites
408 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
T
The Swedish Research Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male with confirmed prostate adenocarcinoma starting systemic therapy for metastatic disease (newly diagnosed hormone sensitive or first-line castration resistant)
- Evidence of distant metastatic disease by bone scan, CT, or MRI
- Adequate health to receive all trial treatments as judged by investigator
- ECOG or WHO performance status of 0 to 2
- Adequate organ and bone marrow function
- Albumin level of at least 28 g/L
- Able to understand study information and provide written informed consent
You will not qualify if you...
- Other cancers within the last 5 years except non-melanoma skin cancer
- Recent serious heart or stroke events within 6 months before randomization
- Uncontrolled high or low blood pressure
- Prior systemic therapy for castration-resistant prostate cancer (except standard androgen deprivation therapy)
- Severe medical conditions increasing risk or interfering with study results
- Inability to follow study procedures
- Current participation in conflicting clinical trials or recent investigational treatments within 28 days
- Unlikely to comply with study protocol
- Any condition posing risk, confounding results, or interfering with participation
- Medical conditions contraindicating study treatments such as serious heart or liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
OLV Ziekenhuis Aalst
Aalst, Belgium
Actively Recruiting
2
GZA Sint-Augustinus
Antwerp, Belgium
Actively Recruiting
3
AZ Sint-Jan AV
Bruges, Belgium, B-8000
Actively Recruiting
4
AZ Sint-Lucas
Bruges, Belgium
Actively Recruiting
5
Ziekenhuis Oost-Limburg
Genk, Belgium
Actively Recruiting
6
University Hospital Ghent
Ghent, Belgium, B-9000
Actively Recruiting
7
AZ Jan Palfijn Ziekenhuis
Ghent, Belgium
Not Yet Recruiting
8
Jessa ziekenhuis
Hasselt, Belgium
Actively Recruiting
9
AZ Groeninge
Kortrijk, Belgium
Actively Recruiting
10
University Hospital Luik
Liège, Belgium
Actively Recruiting
11
AZ Damiaan
Ostend, Belgium
Actively Recruiting
12
VITAZ
Sint-Niklaas, Belgium
Actively Recruiting
13
Ålesund Sjukehus
Ålesund, Norway
Not Yet Recruiting
14
Kreftsenter Kristiansand
Kristiansand, Norway
Actively Recruiting
15
Akershus Universitetssykehus
Lørenskog, Norway
Actively Recruiting
16
Stavanger Universitetssjukehus
Stavanger, Norway
Actively Recruiting
17
Universitetssykehuset Nord-Norge Tromsö
Tromsø, Norway
Not Yet Recruiting
18
Falu lasarett
Falun, Region Dalarna, Sweden, 79182
Actively Recruiting
19
Södra Alvsborgs sjukhus
Borås, Sweden
Actively Recruiting
20
Länssjukhuset Ryhov - Onkologiska kliniken
Jönköping, Sweden, 551 11
Actively Recruiting
21
Länssjukhuset
Kalmar, Sweden, 392 44
Actively Recruiting
22
Centralsjukhuset Region Värmland
Karlstad, Sweden, 651 85
Actively Recruiting
23
Universitetssjukhuset Örebro
Örebro, Sweden
Actively Recruiting
24
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
25
Capio St.Görans Hospital
Stockholm, Sweden
Actively Recruiting
26
Länssjukhuset Sundsvall Härnösand
Sundsvall, Sweden, 851 86
Actively Recruiting
27
Norrlands Universitetssjukhus
Umeå, Sweden, 90185
Actively Recruiting
28
Akademiska sjukhuset
Uppsala, Sweden, 75185
Actively Recruiting
29
Hallands sjukhus Varberg
Varberg, Sweden
Actively Recruiting
30
Centrallasarettet Onkologkliniken
Vaxjo, Sweden, 351 85
Actively Recruiting
31
St. Claraspital
Basel, Switzerland
Actively Recruiting
32
Universitätsspital Basel
Basel, Switzerland
Actively Recruiting
Research Team
B
Berit Larsson, MSc
CONTACT
H
Henrik Grönberg, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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