BridgeMD
New treatment option for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official title ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT03903835
What this study is testing
What is Enzalutamide Oral Capsule?
Enzalutamide Oral Capsule is an investigational medicine, being studied as a potential treatment for metastatic castration-resistant prostate cancer (mcrpc).
Also referred to as Xtandi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Man with histologically confirmed prostate adenocarcinoma, initiating systemic therapy for metastatic disease, encompassing newly diagnosed (i.e. de...
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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
- 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...
- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Antwerp, Belgium
- Bruges, Belgium
- Genk, Belgium
- Ghent, Belgium
- Hasselt, Belgium
- Kortrijk, Belgium
- Liège, Belgium
- Ostend, Belgium
- Sint-Niklaas, Belgium
- Ålesund, Norway
- Kristiansand, Norway
- Lørenskog, Norway
- Stavanger, Norway
- Tromsø, Norway
- Falun, Region Dalarna, Sweden
- Borås, Sweden
- Jönköping, Sweden
- Kalmar, Sweden
- Karlstad, Sweden
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium; Antwerp, Belgium; Bruges, Belgium; Genk, Belgium; Ghent, Belgium; Hasselt, Belgium and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.