HumRes60811
|
SNCTP000004866
|
BASEC2021-02495
|
NCT03903835
ProBio: A result-adaptive and randomized multi-arm biomarker-driven study in patients with metastatic prostate cancer
Summary description of the study
Assessment of the clinical efficacy of selecting treatment classes based on a biomarker signature derived from circulating tumor DNA or tumor tissue DNA in patients with various types of prostate cancer. The aim is to early identify which biomarker signature allows a therapy class to be superior to the standard of care.
(BASEC)
Intervention under investigation
Treatment 1: ARSi (Abiraterone Acetate/Enzalutamide)
Treatment 2: Docetaxel/Cabazitaxel
Treatment 3: Carboplatin
Treatment 4: Niraparib plus Abiraterone acetate plus prednisone
(BASEC)
Disease under investigation
metastatic prostate cancer
(BASEC)
Criteria for participation in trial
1. Male patients aged over 18 years with histologically confirmed prostate adenocarcinoma for whom systemic therapy is initiated due to metastatic disease, including: - Metastatic hormone-sensitive prostate cancer (mHSPC) or - First-line treatment of mCRPC, i.e. first signs of progressive metastatic prostate cancer with castrate serum testosterone levels (<50 ng/dL or 1.7 nmol/L) according to EAU guidelines, including: ● Biochemical progression: Three consecutive PSA rises within 1 week leading to two 50% rises from the nadir value, and PSA >2 ng/ml and/or ● Radiological progression: Appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion according to the Response Evaluation Criteria in Solid Tumors (BASEC)
Exclusion criteria
1. Other malignant diseases within 5 years except non-melanoma skin cancer 2. Within 6 months prior to randomization: myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke, TIA, or congestive heart failure NYHA class III or IV 3. Uncontrolled hypertension. Subjects with a history of hypertension are allowed as long as blood pressure is controlled by antihypertensive treatment. 4. At entry into the mHSPC phase of the study, prior systemic therapy (including ADT) is not permitted. Patients with mCRPC are not allowed to participate in the study if they have already received prior systemic therapy (except standard ADT) for mCRPC. (BASEC)
1. Male patients aged over 18 years with histologically confirmed prostate adenocarcinoma for whom systemic therapy is initiated due to metastatic disease, including: - Metastatic hormone-sensitive prostate cancer (mHSPC) or - First-line treatment of mCRPC, i.e. first signs of progressive metastatic prostate cancer with castrate serum testosterone levels (<50 ng/dL or 1.7 nmol/L) according to EAU guidelines, including: ● Biochemical progression: Three consecutive PSA rises within 1 week leading to two 50% rises from the nadir value, and PSA >2 ng/ml and/or ● Radiological progression: Appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion according to the Response Evaluation Criteria in Solid Tumors (BASEC)
Exclusion criteria
1. Other malignant diseases within 5 years except non-melanoma skin cancer 2. Within 6 months prior to randomization: myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke, TIA, or congestive heart failure NYHA class III or IV 3. Uncontrolled hypertension. Subjects with a history of hypertension are allowed as long as blood pressure is controlled by antihypertensive treatment. 4. At entry into the mHSPC phase of the study, prior systemic therapy (including ADT) is not permitted. Patients with mCRPC are not allowed to participate in the study if they have already received prior systemic therapy (except standard ADT) for mCRPC. (BASEC)
Trial sites
Basel
(BASEC)
Belgium, Norway, Sweden, Switzerland (ICTRP)
Sponsor
Karolinska Institutet, Sweden Universitätsspital Basel
(BASEC)
Contact
Contact Person Switzerland
Dr. med. Ashkan Mortezavi
+41 61 3284177
ashkan.mortezavi@clutterusb.chUniversitätsspital Basel
(BASEC)
General Information
Karolinska Institutet,Karolinska Institutet,Karolinska Institutet,University Hospital Ghent, Belgium,Akershus University Hospital, Norway,University Hospital, Basel, Switzerland,
+46 8 52482576
ashkan.mortezavi@clutterusb.ch(ICTRP)
General Information
Karolinska InstitutetKarolinska InstitutetKarolinska InstitutetUniversity Hospital Ghent, BelgiumUniversity Hospital, AkershusUniversity Hospital, Basel, Switzerland
+46 8 52482576
ashkan.mortezavi@clutterusb.ch(ICTRP)
Scientific Information
Karolinska Institutet,Karolinska Institutet,Karolinska Institutet,University Hospital Ghent, Belgium,Akershus University Hospital, Norway,University Hospital, Basel, Switzerland,
+46 8 52482576
ashkan.mortezavi@clutterusb.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
01.03.2022
(BASEC)
ICTRP Trial ID
NCT03903835 (ICTRP)
Official title (approved by ethics committee)
An outcome-adaptive and randomised multi-arm biomarker driven study in patients with metastatic prostate cancer (ProBio) (BASEC)
Academic title
ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer (ICTRP)
Public title
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer (ICTRP)
Disease under investigation
Metastatic Castration-resistant Prostate Cancer (mCRPC)Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (ICTRP)
Intervention under investigation
Drug: Enzalutamide Oral CapsuleDrug: Abiraterone Oral TabletDrug: CarboplatinDrug: Cabazitaxel 60 mg Solution for InjectionDrug: Docetaxel Injectable SolutionDrug: Radium Chloride Ra-223Drug: Niraparib plus Abiraterone acetate plus PrednisoneDrug: Capivasertib plus DocetaxelDrug: ApalutamideDrug: Darolutamide (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion 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. (ICTRP)
not available
Primary and secondary end points
Progression free survival (PFS) in mCRPC;Progression free survival (PFS) in mHSPC (ICTRP)
Treatment response rate in mCRPC;Overall survival (OS);Patient Reported Outcome Measures (PROM);Cost-effectiveness;Number of Participants With Adverse Events as a Measure of Safety and Tolerability;Treatment response rate in mHSPC (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
The Swedish Research Council;Kom Op Tegen Kanker;Janssen Pharmaceutica N.V., Belgium;AstraZeneca;Cancerfonden (ICTRP)
Additional contacts
Henrik Gr?nberg, Professor;Martin Eklund, Professor;Johan Lindberg, PhD;Piet Ost, Professor;Jan Oldenburg, Professor;Ashkan Mortezavi, MD, PhD;Berit Larsson, MSc, berit.larsson@ki.se, +46 8 52482576, Karolinska Institutet,Karolinska Institutet,Karolinska Institutet,University Hospital Ghent, Belgium,Akershus University Hospital, Norway,University Hospital, Basel, Switzerland, (ICTRP)
Secondary trial IDs
EudraCT No 2018-002350-78 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT03903835 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available