Prognostic Value of the Circulating Tumor DNA Fraction in Metastatic Castration-resistant Prostate Cancer: Results from the ProBio Platform Trial.
Alessio Crippa, Bram De Laere, Andrea Discacciati...
https://pubmed.ncbi.nlm.nih.gov/40263079Actively Recruiting
Phase 3
Age: 18Years +
MALE
ID03903835
ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer
Led by Karolinska Institutet · Updated on 2025-04-09
750
Participants Needed
32
Research Sites
N/A
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
Researchers are evaluating treatments for patients with metastatic prostate cancer, including both hormone-sensitive and castration-resistant forms. This international trial uses biomarker signatures identified from tumor or liquid biopsies to guide treatment assignments. The study compares standard care based on national guidelines with experimental treatments tailored to genetic changes related to prostate cancer. It uses an adaptive design to assign treatments based on ongoing results to improve patient outcomes. Participants are randomized to either a control group receiving standard care or an experimental group receiving treatments matched to their biomarker profile. Experimental treatments include androgen receptor signaling inhibitors, taxane-based chemotherapy combined with AR inhibitors, PARP inhibitors, AKT inhibitors, and carboplatin, depending on the biomarker signature and disease stage. Patients progressing during the trial may be re-assigned up to three times to different treatments based on updated biomarker profiles. Throughout the study, patients undergo regular assessments including progression-free survival monitoring up to 60 months. Researchers also track treatment response rates, overall survival, patient-reported outcomes, cost-effectiveness, and safety through adverse event reports. An independent board regularly reviews data to evaluate treatment effectiveness and may modify treatment assignments accordingly. The trial aims to personalize therapy for metastatic prostate cancer based on genetic markers.
CONDITIONS
Brief Title
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Male with confirmed prostate adenocarcinoma starting systemic treatment for metastatic disease
- Diagnosis includes newly diagnosed hormone sensitive or first-line castration resistant metastatic prostate cancer
- Evidence of distant metastatic disease shown by bone scan, CT, or MRI
- Assessed healthy enough by investigator to receive all treatments in the trial
- Performance status score between 0 and 2
- Adequate organ and bone marrow function
- Albumin level greater than or equal to 28 g/L
- Able to understand information and provide written informed consent
You will not qualify if you...
- Other cancers diagnosed within 5 years, except non-melanoma skin cancer
- Recent (within 6 months) serious heart events such as heart attack, unstable angina, angioplasty, bypass surgery, stroke, transient ischemic attack, or severe heart failure
- Uncontrolled high or low blood pressure
- Prior systemic therapy for castration resistant prostate cancer except standard ADT
- Severe acute or chronic medical conditions increasing risk or affecting study results
- Unable to follow study procedures
- Participation in conflicting clinical trials or recent investigational treatments within 28 days
- Conditions or situations posing risk, confounding results, or interfering with participation
- Medical conditions contraindicating study treatments, such as significant heart or liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 60 months or until disease progression, whichever occurs first
Participants are randomized to receive either standard care or biomarker-driven experimental drug treatments based on their biomarker signatures. Those in the experimental arm may receive one or multiple drugs targeting specific genetic alterations. Treatment assignments may change if the disease progresses, with up to three consecutive treatments allowed.
Regular visits for treatment administration and monitoring as per protocol
Follow-up
Duration - Up to 60 months from enrollment
Participants are monitored after treatment ends to assess progression-free survival, overall survival, treatment response, safety, and patient-reported outcomes for up to 60 months from enrollment.
Periodic visits for assessments and monitoring
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
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Research Team
B
Berit Larsson, MSc
H
Henrik Grönberg, Professor
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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Published Research Related To This Trial
Androgen receptor pathway inhibitors and taxanes in metastatic prostate cancer: an outcome-adaptive randomized platform trial.
Bram De Laere, Alessio Crippa, Andrea Discacciati...
https://pubmed.ncbi.nlm.nih.gov/39164518Clinical Trial Protocol for ProBio: An Outcome-adaptive and Randomised Multiarm Biomarker-driven Study in Patients with Metastatic Prostate Cancer.
Bram De Laere, Alessio Crippa, Andrea Discacciati...
https://pubmed.ncbi.nlm.nih.gov/35317973The ProBio trial: molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer.
Alessio Crippa, Bram De Laere, Andrea Discacciati...
https://pubmed.ncbi.nlm.nih.gov/32586393