E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prostate cancer |
Eturauhassyöpä |
|
E.1.1.1 | Medical condition in easily understood language |
Prostate cancer |
Eturauhassyöpä |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Reduction of intraprostatic inflammation and inhibition of prostate cancer growth with short-term atorvastatin treatment. |
Eturauhaskudoksen tulehduksen vähentäminen sekä eturauhassyövän kasvun hidastaminen lyhtaikaisella atorvastatiinilääkityksellä. |
|
E.2.2 | Secondary objectives of the trial |
Clarification of correlations between prostate cancer growth response and changes in serum cholesterol parameters and prostate tissue cholesterol metabolism. Measurement of intraprostatic concentration of atorvastatin. |
Selvittää, kuinka eturauhassyövän kasvumuutokset korreloivan seerumin kolesteroliarvojen muutosten sekä eturauhaskudoksen kolesteroliaineenvaihdunnan muutosten kanssa. Eturauhasen sisäisen atorvastatiinipitoisuuden mittaaminen. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histologically confirmed diagnosis of prostate adenocarcinoma
- Radical prostatectomy is chosen as prostate cancer treatment
- No prior cancer treatments of any kind
- The patient agrees to participate and signs an informed consent |
- Histologisesti varmennettu eturauhasen adenokarsinooma
- Hoidoksi valitaan eturauhasen poistoleikkaus
- Ei aiempia syöpähoitoja
- Potilas suostuu osallistumaan tutkimukseen ja allekirjoittaa suostumuksen |
|
E.4 | Principal exclusion criteria |
- Any previous cancer treatment
- Usage of cholesterol-lowering medication, finasteride or dutasteride within a year from study inclusion
- Difficult renal or liver insufficiency
- Previous adverse effect during cholesterol-lowering treatment
- Usage of drugs or herbs during the study period that interact with atorvastatin (St John's Wort, HIV protease inhibitors, cyklosporin, macrolides, fusidic acid, phenytoin, carbamatsepin, dronedarone or oral antifungal drugs) |
- Aiemmat syöpähoidot mihin tahansa syöpään
- Kolesterolia alentavien lääkkeiden, finasteridin tai dutasteridin käyttö viimeisen vuoden aikana ennen tutkimuksen alku
- Maksan tai munuaisten vaikea vajaatoiminta
- Aiemmin ilmenneet hankalat sivuvaikutukset kolesterolilääkityksen aikana
- Atorvastatiinin kanssa yhteisvaikutuksia omaavien lääkeaineiden jatkuva käyttö tutkimusaikana (mäkikuisma, HIV-infektion hoidossa käytetyt proteaasi-inhibiittorit, siklosporiini, makrolidi-ryhmän antibiootit, fusidiinihappo, fenytoiini, karbamatsepiinihappo, dronedaroni, oraaliset sienilääkkeet) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
12-54% decrease in cell cycle activity, increased apoptosis, reduced lymphocyte infiltration in the prostate cancer tissue. |
12-54% lasku solunjakautumisaktiivisuudessa, apoptoosin lisääntyminen, eturauhassyöpäkudoksen alentunut lymfosyytti-infiltraatio |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After radical prostatectomy, i.e. in average four weeks from randomization to either study arm. |
Eturauhasen poistoleikkauksen jälkeen, n. neljän viikon kuluttua tutkimusryhmään satunnaistamisesta. |
|
E.5.2 | Secondary end point(s) |
Decreased serum PSA, correlation between prostate cancer growth activity and serum cholesterol parameters (total cholesterol, HDL, LDL, ApoA, Apoe), changes in protein expression of key cholesterol regulators in prostate tissue (HMGCR, LDL-R, SREBP2, ABCA1). Measurable atorvastatin concentration in prostate tissue. |
Alentunut seerumin PSA-arvo, yhteys eturauhassyövän kasvuaktiivisuuden ja seerumin kolesteroliarvojen (kokonaiskolesteroli, HDL, LDL, ApoA, ApoE) välillä, muutokset eturauhaskudoksen keskeisten kolesterolimetabolian säätelijöiden (HMGCR, LDL-R, SREBP2, ABCA1) ilmenemisessä. Mitattavaksi tuleva atorvastatiinipitoisuus eturauhaskudoksessa. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the entire data has been collected and all tissue and serum samples have been collected and analyzed. |
Kun kaikki tutkimusaineisto on kerätty ja kudos- sekä verinäytteet analysoitu. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Radical prostatectomy of the last patient included in the trial. |
Viimeisen tutkimukseen sisällytetyn potilaan eturauhasen poistoleikkaus. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |