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ProBio: An outcome-adaptive and randomised multi-arm biomarker driven study in patients with metastatic prostate cancer
EU CTIS ID: 2023-506857-40-00
What this study is testing
To determine whether a therapy class choice or de-escalating treatment regimen based on a biomarker signature or ctDNA detectability can improve PFS compared to a control arm in patients with mHSPC and mCRPC.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ● Male patients, aged above 18 years, with histologically confirmed prostate adenocarcinoma, initiating systemic therapy for metastatic disease, encompassing: ○ Newly diagnosed (i.e. de-novo) metastatic hormone-sensitive prostate cancer (mHSPC) or ○ Recurrent (i.e. metachronous) mHSPC ■ Patients that have had prior local treatment with curative intent (e.g. primary radiotherapy or radical prostatectomy) and subsequently develop metachronous metastatic disease. These metachronous or recurring mHSPC patients are those observed in the setting of rising PSA until metastasis develops. Patients are not required to be ADT-naïve, but must have normal levels of testosterone (>50 ng/dL or 1.7 nmol/L) at ProBio screening and liquid biopsy collection or ○ First-line mCRPC, i.e. first evidence of progressive metastatic prostate cancer under castrate levels (<50 ng/dL) of serum testosterone, as defined by the EAU guidelines, encompassing: ■ Biochemical progression: Three consecutive rises in PSA 1 wk apart, resulting in two 50% increases over the nadir, and PSA >2 ng/ml and/or ■ Radiologic progression: The appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion using the Response Evaluation Criteria in Solid Tumours. ● For the initial identification of patients with metastatic disease, distant metastases can either be identified by conventional imaging (i.e. bone scan or metastatic lesions on CT or MRI), or molecular imaging (i.e. miM1 disease on prostate-specific membrane antigen (PSMA) targeting positron emission tomography (PET)). Radiology taken within 6 weeks of screening may be used, if older a new scan needs to be taken. It is important to note that PSMA PET/CT can be used for initial identification and enrollment of patients with metastatic disease, but that it may not be used for response assessment or to infer disease progression. Radiographic follow-up and assessment of progression need to be performed with conventional imaging. ● Adequate health, hematologic, hepatic, and renal function, as assessed by the investigator, to receive all available treatments in the trial in each disease state (mHSPC and mCRPC) (i.e. haemoglobin ≥ 100 g/L (blood transfusion not less than 21 days prior to screening), absolute neutrophil count ≥ 1.5 x 10^9/L, platelets ≥100 x 10^9/L and Total bilirubin < 1.5 ULN (patients with Gilberts Syndrome bilirubin < 40 µg/L) and AST and ALT ≤ 1.5 ULN (or ≤ 3 ULN in the presence of liver metastases) and serum creatinine not greater than 1 ULN (if serum creatinine is between 1 and 1.5 ULN, patients may be eligible provided that the calculated GFR is at least 50 ml/min measured directly by 24-hour urine sampling OR using Cockcroft-Gault method) ● Albumin greater than or equal to 28 g/L ● ECOG/WHO performance status 0-2 ● Agrees to use an effective contraceptive method during and up to 6 months after study drug treatment and should not donate sperm during this period. ● Able to understand the patient information and sign written informed consent.
You likely can't join if
- ● Other malignancies within 5 years except non-melanoma skin cancer ● Within 6 months of randomisation: myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke, TIA, or congestive heart failure NYHA class III or IV ● Uncontrolled hypertension: SBP > 160 mmHg and or DBP > 95 mmHg. Subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment ● Uncontrolled hypotension: SBP < 90 mmHg and/or DBP < 50 mmHg ● Upon entering the mHSPC phase of the trial, prior systemic therapy (including ADT) is not allowed. Patients with mCRPC may not enter the trial when they have already received prior systemic therapy (with the exception of standard ADT) for mCRPC. ● 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. This includes a medical history significant for arrhythmia (e.g. multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigators judgement with cardiologist consultation recommended. ● Unable to comply with study procedures ● Current participation in another clinical trial that will be in conflict with the present study, e.g. administration of an investigational therapeutic or invasive surgical procedure within 28 days prior to study enrolment. Imaging-based interventional trials are allowed as long as the conventional imaging intervals within ProBio are preserved. ● Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study ● 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 subject’s participation in this study. This includes a history of QT prolongation associated with other medications that required discontinuation of that medication; and other factors that increase the risk of OTc prolongation or risk of arrhythmic events, hypokalemia of grade >1, potential for Torsade de Pointes, congenital long QT syndrome. ● Any medical condition that would make use of the study treatments contraindicated, according to the SmPC, e.g. significant heart or liver disease. The investigator should check the SmPC and/or IB for the assigned study treatments. This includes a family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives. ● The determination of a biomarker signature is necessary to randomise patients during ProBio mCRPC. Patients with detectable ctDNA and having a microsatellite unstable (MSI) or hypermutated tumor will be excluded from the trial since the plethora of mutations obscures a proper assessment of the disease-driving biomarker signature. Patients will therefore be excluded in case of: a. For patients in mCRPC: undetectable levels of ctDNA. b. For patients in mHSPC and mCRPC: microsatellite unstable (MSI+) or hypermutated tumor.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. 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 EU CTIS; the study team decides eligibility.