HumRes60811
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SNCTP000004866
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BASEC2021-02495
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NCT03903835
ProBio: A result-adaptive and randomized multi-arm biomarker-driven study in patients with metastatic prostate cancer
Descrizione riassuntiva dello studio
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)
Intervento studiato
Treatment 1: ARSi (Abiraterone Acetate/Enzalutamide)
Treatment 2: Docetaxel/Cabazitaxel
Treatment 3: Carboplatin
Treatment 4: Niraparib plus Abiraterone acetate plus prednisone
(BASEC)
Malattie studiate
metastatic prostate cancer
(BASEC)
Criteri di partecipazione
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)
Criteri di esclusione
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)
Criteri di esclusione
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)
Luogo dello studio
Basilea
(BASEC)
Belgium, Norway, Sweden, Switzerland (ICTRP)
Sponsor
Karolinska Institutet, Sweden Universitätsspital Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. med. Ashkan Mortezavi
+41 61 3284177
ashkan.mortezavi@clutterusb.chUniversitätsspital Basel
(BASEC)
Informazioni generali
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)
Informazioni generali
Karolinska InstitutetKarolinska InstitutetKarolinska InstitutetUniversity Hospital Ghent, BelgiumUniversity Hospital, AkershusUniversity Hospital, Basel, Switzerland
+46 8 52482576
ashkan.mortezavi@clutterusb.ch(ICTRP)
Informazioni scientifiche
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)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
01.03.2022
(BASEC)
ID di studio ICTRP
NCT03903835 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
An outcome-adaptive and randomised multi-arm biomarker driven study in patients with metastatic prostate cancer (ProBio) (BASEC)
Titolo accademico
ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer (ICTRP)
Titolo pubblico
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer (ICTRP)
Malattie studiate
Metastatic Castration-resistant Prostate Cancer (mCRPC)Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (ICTRP)
Intervento studiato
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)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
The Swedish Research Council;Kom Op Tegen Kanker;Janssen Pharmaceutica N.V., Belgium;AstraZeneca;Cancerfonden (ICTRP)
Contatti aggiuntivi
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)
ID secondari
EudraCT No 2018-002350-78 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03903835 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile