Brief description of trial (Data source: BASEC)
Der Zweck dieser Studie ist es, herauszufinden, ob die Kombination von Metformin, einem bekannten Blutzucker senkenden Medikament, mit Enzalutamid (Xtandi®) im Vergleich zu Enzalutamid alleine eine bessere Wirkung gegen metastasierten Prostatakrebs zeigt. Zudem soll die Sicherheit der Kombination erforscht werden.
Health conditions investigated(Data source: BASEC)
Metastasierter Prostatakrebs
Health conditions
(Data source: WHO)
Cancer of the Prostate;Prostate Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Sie werden nach einem Zufallsprinzip einer Behandlung (Arm A: Metformin + Enzalutamid; Arm B: Enzalutamid allein) zugeteilt. Wenn Sie mit Enzalutamid alleine behandelt werden erhalten Sie dieselbe Therapie wie sie der Standardbehandlung entspricht.
Interventions
(Data source: WHO)
Drug: Enzalutamide;Drug: Metformin
Criteria for participation in trial
(Data source: BASEC)
- Prostatakrebs mit Metastasen
- Kein Ansprechen mehr auf alleinige Standardhormontherapie
Exclusion criteria
(Data source: BASEC)
- Patienten die weiterhin nicht mit Standardhormontherapie behandelt werden möchten,
- Patienten welche Erkrankungsherde im zentralen Nervensystem ausweisen,
- Patienten die grössere Operationen oder die welche eine Therapie zur Blutverdünnung mit Warfarin und Rivaroxaban benötigen
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: Male
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Written informed consent according to ICH/GCP regulations before registration and
prior to any trial-related investigations
- Histologically or cytological confirmed adenocarcinoma of the prostate without small
cell carcinoma or small cell components
- Asymptomatic or minimally symptomatic patients in relation to disease
- Metastatic adenocarcinoma of the prostate documented by imaging (CT/MRI and/or bone
scan)
- Ongoing androgen deprivation therapy with Gonadotropin-releasing hormone GnRH
analogues or bilateral orchiectomy (i.e. surgical or medical castration)
- Total testosterone levels = 1.7 nmol/L (corresponding to = 50 ng/dL)
- Tumor progression at the time of registration, defined as per protocol.
- Completed baseline QoL and pain questionnaires
- Male patients = 18 years
- WHO performance status 0-2
- Adequate hematologic values: hemoglobin = 90 g/L, neutrophils = 1.0 x 109/L, platelets
= 75 x 109/L
- Adequate hepatic function: ALT and AST = 2.5 x ULN, bilirubin = 1.5 x ULN (exception
if Gilbert's syndrome = 2.5 x ULN)
- Adequate renal function: calculated creatinine clearance = 50 mL/min, according to the
formula of Cockcroft-Gault
- Patient is able to swallow the trial drugs and comply with trial requirements
- Patient agrees not to father a child during participation in the trial and during 3
months thereafter
- Patient agrees to participate to the mandatory translational research part of the
trial with exception of Pyruvate dehydrogenase sub-study.
Exclusion Criteria:
- Known or suspected Central nervous system CNS metastases or active leptomeningeal
disease
- Previous malignancy within 2 years prior to registration, with the exception of
localized non-melanoma skin cancer and Ta and Tis bladder cancer
- Prior treatment for prostate cancer with
- novel endocrine agents (including abiraterone acetate, enzalutamide, TAK-700,
TAK-683, TAK-448, VT464, darolutamide, apalutamide),
- radioisotopes,
- TKI and other small molecules,
- immunotherapy,
- chemotherapy (with the exception of docetaxel chemotherapy in hormone sensitive
prostate cancer)
- Treatment with experimental drugs or treatment within a clinical trial within 30 days
prior to registration (except the clinical trial SAKK 96/12, PEACE-4 and/or the
biobank project SAKK 63/12)
- Clinically significant cardiovascular disease including:
- Myocardial infarction within 6 months prior to registration,
- Uncontrolled angina within 3 months prior to registration,
- Congestive heart failure NYHA class III or IV,
- QTc interval > 480 ms,
- History of clinically significant ventricular arrhythmias (e.g. ventricular
tachycardia, ventricular fibrillation, torsades de pointes),
- History of Mobitz II second or third degree heart block without a permanent
pacemaker in place,
- Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg OR
diastolic blood pressure > 105 mmHg
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
investigator, would make the patient inappropriate for enrollment (e.g. uncontrolled
or acute severe infection, advanced chronic obstructive pulmonary disease, heart
failure)
- Known history of HIV, hepatitis B, hepatitis C
- Major surgery within 4 weeks prior to registration
- Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer
disease within 3 months prior to registration)
- Treatment with metformin within the last 6 months prior to registration
- Patients on pharmacotherapy for diabetes mellitus
- History of diabetic ketoacidosis, diabetic coma and pre-coma
- Known history of seizures or any conditions that may predispose to seizure. History of
loss of consciousness or transient ischemic attack within 12 months prior to
registration
- Concurrent anticoagulation with rivaroxaban or warfarin
- Known hypersensitivity to the IMPs or hypersensitivity to any of their components
- Any concomitant drugs contraindicated for use with the IMPs according to the
Swissmedic approved product information
- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the trial protocol and follow-up.
-
Further information on trial
Date trial registered
Dec 22, 2015
Recruitment status
Terminated
Academic title
(Data source: WHO)
Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone (IMPROVE TRIAL): A Randomized, Open Label, Phase II Trial
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 2
Primary end point
(Data source: WHO)
Disease control (DC)
Secundary end point
(Data source: WHO)
Overall response (OR);Event-free survival (EFS);Adverse events (AEs);Overall survival (OS)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Aarau, Baden, Basel, Bellinzona, Chur, Frauenfeld/Münsterlingen, Freiburg, Geneva, Lausanne, Luzern, Olten, Sion, Sion mit Subzentrum Martigny, Solothurn, St. Gallen, Winterthur, Zurich
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
SAKK, Corinne Schär, PhD
+41 31 389 91 91
trials@sakk.ch
Contact for general information
(Data source: WHO)
Christian Rothermundt, MD
Cantonal Hospital of St. Gallen
Contact for scientific information
(Data source: WHO)
Christian Rothermundt, MD
Cantonal Hospital of St. Gallen
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Ostschweiz (EKOS)
Date of authorisation by the ethics committee
06.04.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-00127
Secondary ID (Data source: WHO)
SAKK 08/14 - IMPROVE
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