Biomarker-driven treatment for metastatic prostate cancer
ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer
PHASE3 · Karolinska Institutet · NCT03903835
This study is testing if personalized treatments based on specific genetic markers can help people with advanced prostate cancer feel better compared to standard care.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Karolinska Institutet (other) |
| Drugs / interventions | chemotherapy |
| Locations | 32 sites (Aalst and 31 other locations) |
| Trial ID | NCT03903835 on ClinicalTrials.gov |
What this trial studies
ProBio is an international, multi-arm, open-label trial designed to evaluate treatments for patients with metastatic prostate cancer based on specific biomarker signatures. Patients will be randomized into control or experimental arms, with the control group receiving standard care while the experimental group receives treatments tailored to their biomarker profiles identified through liquid biopsies or tissue samples. The trial focuses on both metastatic hormone-sensitive and castration-resistant prostate cancer, utilizing a gene panel to determine the most effective treatment options. This approach aims to personalize therapy and improve outcomes for patients with advanced prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed prostate adenocarcinoma who are initiating systemic therapy for metastatic disease.
Not a fit: Patients with other malignancies within the past five years or recent serious cardiovascular events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized treatment options for patients with metastatic prostate cancer.
How similar studies have performed: Other studies have shown promise with biomarker-driven approaches in cancer treatment, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) * Distant metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI * Adequate health as assessed by the investigator to receive all available treatments in the trial * ECOG/WHO (Eastern Cooperative Oncology Group/ World Health Organization) performance score 0-2 * Adequate organ and bone marrow function * Albumin greater than or equal to 28 g/L * Able to understand the patient information and sign written informed consent Exclusion Criteria: * Other malignancies within 5 years except non-melanoma skin cancer * 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 * Uncontrolled hypertension * Uncontrolled hypotension * Received systemic therapy (with the exception of standard ADT) prior to study inclusion, for the CRPC indication * 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 * Unable to comply with study procedures * 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 * Patients who are unlikely to comply with the protocol * 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. * Any medical condition that would make use of the study treatments contraindicated, according to the SmPC, e.g. significant heart or liver disease.
Where this trial is running
Aalst and 31 other locations
- OLV Ziekenhuis Aalst — Aalst, Belgium (RECRUITING)
- GZA Sint-Augustinus — Antwerp, Belgium (RECRUITING)
- AZ Sint-Jan AV — Bruges, Belgium (RECRUITING)
- AZ Sint-Lucas — Bruges, Belgium (RECRUITING)
- Ziekenhuis Oost-Limburg — Genk, Belgium (RECRUITING)
- University Hospital Ghent — Ghent, Belgium (RECRUITING)
- AZ Jan Palfijn Ziekenhuis — Ghent, Belgium (NOT_YET_RECRUITING)
- Jessa ziekenhuis — Hasselt, Belgium (RECRUITING)
- AZ Groeninge — Kortrijk, Belgium (RECRUITING)
- University Hospital Luik — Liège, Belgium (RECRUITING)
- AZ Damiaan — Ostend, Belgium (RECRUITING)
- VITAZ — Sint-Niklaas, Belgium (RECRUITING)
- Ålesund Sjukehus — Ålesund, Norway (NOT_YET_RECRUITING)
- Kreftsenter Kristiansand — Kristiansand, Norway (RECRUITING)
- Akershus Universitetssykehus — Lørenskog, Norway (RECRUITING)
- Stavanger Universitetssjukehus — Stavanger, Norway (RECRUITING)
- Universitetssykehuset Nord-Norge Tromsö — Tromsø, Norway (NOT_YET_RECRUITING)
- Falu lasarett — Falun, Region Dalarna, Sweden (RECRUITING)
- Södra Alvsborgs sjukhus — Borås, Sweden (RECRUITING)
- Länssjukhuset Ryhov - Onkologiska kliniken — Jönköping, Sweden (RECRUITING)
- Länssjukhuset — Kalmar, Sweden (RECRUITING)
- Centralsjukhuset Region Värmland — Karlstad, Sweden (RECRUITING)
- Universitetssjukhuset Örebro — Örebro, Sweden (RECRUITING)
- Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
- Capio St.Görans Hospital — Stockholm, Sweden (RECRUITING)
- Länssjukhuset Sundsvall Härnösand — Sundsvall, Sweden (RECRUITING)
- Norrlands Universitetssjukhus — Umeå, Sweden (RECRUITING)
- Akademiska sjukhuset — Uppsala, Sweden (RECRUITING)
- Hallands sjukhus Varberg — Varberg, Sweden (RECRUITING)
- Centrallasarettet Onkologkliniken — Vaxjo, Sweden (RECRUITING)
- St. Claraspital — Basel, Switzerland (RECRUITING)
- Universitätsspital Basel — Basel, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Henrik Grönberg, Professor — Karolinska Institutet
- Study coordinator: Berit Larsson, MSc
- Email: berit.larsson@ki.se
- Phone: +46 8 52482576
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer, mCRPC, mHSPC, cfDNA, Genomics, Liquid Biopsy