ProBio: Eine ergebnisadaptive und randomisierte mehrarmige biomarkergesteuerte Studie bei Patienten mit metastasiertem Prostatakrebs

Drug: Enzalutamide Oral Capsule;Drug: Abiraterone Oral Tablet;Drug: Carboplatin;Drug: Cabazitaxel 60 mg Solution for Injection;Drug: Docetaxel Injectable Solution;Drug: Radium Chloride Ra-223;Drug: Niraparib plus Abiraterone acetate plus Prednisone;Drug: Capivasertib plus Docetaxel;Drug: Apalutamide;Drug: Darolutamide

Gender: Male
Maximum age: N/A
Minimum age: 18 Years

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.