ProBio: An outcome adaptive and randomised multi-arm biomarker drivenstudy in patients with metastatic prostate cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 2000

Inclusion Criteria

• Male patients, aged above 18 years, with histologically confirmed
prostate adenocarcinoma, initiating systemic therapy for metastatic
disease, encompassing:
1. Newly diagnosed metastatic hormone-sensitive
prostate cancer (mHSPC)
or
2. 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)
• Distant metastatic disease documented by positive bone scan or
metastatic lesions on CT or MRI. Radiology taken within 6 weeks of
inclusion may be used, if older a new scan needs to be taken.
• Adequate health, hematologic, hepatic, and renal function as
assessed by the investigator to receive all available trial treatments in
mHSPC and mCRPC setting respectively.
• ECOG/WHO performance score 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1600

Exclusion Criteria

• The determination of a biomarker signature is necessary to
randomise patients during ProBio. Patients with mCRPC with
undetectable levels of ctDNA will therefore be excluded. In case of de
novo mHSPC, failure to detect ctDNA or somatic alterations from the
primary tumour biopsies will exclude the patient from the trial
• Other malignancies within 5 years except non-melanoma skin cancer
• Within 6 months of randomization: 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
4. 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 interpretationof study results. This includes a medical history significant forarrhythmia (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.
• 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 (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
• 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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