NCT03903835 ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
| NCT ID | NCT03903835 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Karolinska Institutet |
| Condition | Metastatic Castration-resistant Prostate Cancer (mCRPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2019-02-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 750 participants in total. It began in 2019-02-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Henrik Grönberg, Professor
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT03903835 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Castration-resistant Prostate Cancer (mCRPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03903835 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 750 participants.
Is NCT03903835 currently recruiting?
Yes, NCT03903835 is actively recruiting participants. Contact the research team at berit.larsson@ki.se for enrollment information.
Where is the NCT03903835 trial being conducted?
This trial is being conducted at Aalst, Belgium, Antwerp, Belgium, Bruges, Belgium, Bruges, Belgium and 11 additional locations.
Who is sponsoring the NCT03903835 clinical trial?
NCT03903835 is sponsored by Karolinska Institutet. The principal investigator is Henrik Grönberg, Professor at Karolinska Institutet. The trial plans to enroll 750 participants.
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