PEACE-4 Phase III Studie, die die Wirkung von Acetylsalicylsäure und Atorvastatin bei Patienten mit einem kastrationsresistenten Prostatakarzinom untersucht

Drug: Acetylsalicylic acid;Drug: Atorvastatin

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate and no curative local therapy
considered possible

- Age = 18 years, life expectancy of at least 6 months

- CRPC defined as tumor progression (PSA increase on at least 2 separate values
separated by at least 1 week or progression on imaging) while on Androgen Deprivation
Therapy (orchiectomy, LHRH agonist or -antagonist) with documented serum testosterone
levels = 1.7 nmol/L (= 0.50 ng/mL). Ongoing concurrent use of LHRH agonist or
antagonist is required if the patient has not been surgically castrated

- Presence (M1) or absence (M0) of metastases on imaging

- Performance status 0, 1 or 2

- No previous use of life- prolonging treatments for CRPC (including abiraterone,
enzalutamide, radium-223, docetaxel, cabazitaxel, and sipuleucel-T). The use of these
agents together with Androgen Deprivation Therapy (ADT) for castrate-sensitive disease
is allowed.

- Adequate renal function within 30 days prior to registration: calculated creatinine
clearance = 50 mL/min, according to the formula of Cockcroft-Gault and adequate liver
function with levels of AST and ALT = 3xULN and no signs for cholestasis.

- Participation in other clinical trials is allowed except for trials with the same
primary endpoint, i.e. OS

- Patient authorized to participate to a clinical trial by specific country regulation
(eg patient affiliated to a social security system or beneficiary of the same)

- Information delivered to patient and informed consent form signed by the patient.

Exclusion Criteria:

- Previous localised malignancy within 2 years with the exception of localized
non-melanoma skin cancer and Ta or Tis bladder cancer (patients with asymptomatic
Chronic Lymphocytic Leukemia can be included)

- Previous metastatic malignancy within 5 years

- Patient currently taking daily acetylsalicylic acid or a daily statin within the last
6 months

- Patients with active liver disease (hepatitis B or C, cirrhosis) or unexplained
persistent elevations of serum transaminases exceeding 3 times the upper limit of
normal or cholestasis

- Patients with excessive alcohol intake or history of a relevant liver disease

- Known hypersensitivity or intolerance to acetylsalicylic acid or atorvastatin or
hypersensitivity to any of its components

- Contra-indication to acetylsalicylic acid or atorvastatin according to label,
including known high-risk for haemorrhage,

- History of or active myopathy or significantly elevated (> 5 times ULN) CK levels

- History of recent stroke or transient ischemic attack (TIA).

- Any concomitant drugs contraindicated for use with the trial drugs according to the
product information (e.g. Fusidic acid, potent inhibitors of CYP3A4 or transport
proteins: ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol,
ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors
including ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir,
telaprevir, saquinavir, darunavir, fosamprenavir, boceprevir, gemfibrozil,
fenofibrate, etc)

- Any serious underlying medical condition (by the investigator's judgement) which could
impair the ability of the patient to participate in the trial

- Patients with hereditary galactose intolerance, Lapp-lactase deficiency or
Glucose-Galactose-malabsorption

- Compliance with trial medical follow-up impossible due to geographic, social or
psychological reasons

- Psychiatric disorder precluding understanding of information about trial related
topics, providing informed consent, or interfering with compliance for oral drug
intake