natgillin/translations-raw huggingface dataset:
Additional changes to reproductive tissues included hypertrophy/hyperplasia of the pituitary gland and atrophy in seminal vesicles in rats and testicular hypospermia and seminiferous tubule degeneration in dogs.
Dodatne promjene u reproduktivnim tkivima uključivale su hipertrofiju/hiperplaziju pituitarne žlijezde i atrofiju sjemenih mjehurića u štakora i testikularnu hipospermiju i degeneraciju sjemenovoda u pasa.
Fifty-one percent (51%) of patients were on bisphosphonates at baseline.
Na početku je 51% bolesnika bilo na bisfosfonatima.
Figure 8: Overall survival by subgroup in the AFFIRM study - Hazard ratio and 95% confidence interval
Slika 8: Ukupno preživljenje prema podskupinama u ispitivanju AFFIRM - omjer hazarda i interval pouzdanosti od 95%
In studies in mice (4 weeks), rats (4 and 26 weeks) and dogs (4, 13, and 39 weeks), changes in the reproductive organs associated with enzalutamide were decreases in organ weight with atrophy of the prostate and epididymis.
U ispitivanjima na miševima (4 tjedna), štakorima (4 i 26 tjedana) i psima (4, 13 i 39 tjedana), promjene u reproduktivnim organima povezane s enzalutamidom sastojale su se od smanjenja težine organa s atrofijom prostate i pasjemenika.
Hepatic impairment did not have a pronounced effect on the total exposure to enzalutamide or its active metabolite.
Oštećenje funkcije jetre nije imalo izražen učinak na ukupnu izloženost enzalutamidu ili njegovim aktivnim metabolitima.
In vitro data indicate that enzalutamide may be an inhibitor of the efflux transporter P-gp.
In vitro podaci pokazuju da enzalutamid može inhibirati efluksni transporter P-gp.
Enzalutamide treatment decreases the growth of prostate cancer cells and can induce cancer cell death and tumour regression.
Liječenje enzalutamidom smanjuje rast stanica raka prostate i može inducirati smrt stanica raka te povlačenje tumora.
The European Medicines Agency has waived the obligation to submit the results of studies with enzalutamide in all subsets of the paediatric population in prostate carcinoma (see section 4.2 for information on paediatric use).
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka enzalutamida u svim podskupinama pedijatrijske populacije u karcinomu prostate (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Concomitant use of enzalutamide with medicinal products that are sensitive substrates of many metabolising enzymes or transporters (see section 4.5) should generally be avoided if their therapeutic effect is of large importance to the patient, and if dose adjustments cannot easily be performed based on monitoring of efficacy or plasma concentrations.
Istovremenu primjenu enzalutamida s lijekovima koji su osjetljivi supstrati mnogih metabolizirajućih enzima ili transportera (vidjeti dio 4.5) potrebno je izbjegavati ukoliko je njihov terapijski učinak od velike važnosti za bolesnika, a prilagodba doze nije jednostavna jer se temelji na praćenju djelotvornosti ili koncentracija u plazmi.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Ako Vam je liječnik rekao da ne podnosite neke vrste šećera, obratite se liječniku prije nego što uzmete ovaj lijek.
• the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).
• liječenje odraslih muškaraca s visokorizičnim nemetastatskim rakom prostate rezistentnim na kastraciju (engl. castration-resistant prostate cancer, CRPC) (vidjeti dio 5.1).
Uncommon (may affect up to 1 in 100 people) Hallucinations, difficulty thinking clearly, low white blood cell count
Manje često (mogu se javiti u do 1 na 100 osoba) Halucinacije, otežano prosuđivanje, nizak broj bijelih krvnih stanica
Seizures were reported in 4 in every 1,000 people taking Xtandi, and in fewer than one in every 1,000 people taking placebo.
Napadaji su zabilježeni u 4 na svakih 1000 osoba koje su uzimale Xtandi i kod manje od jedne na svakih 1000 osoba koje su uzimale placebo.
Gender differences were noted in rat mammary glands (male atrophy and female lobular hyperplasia).
Razlike s obzirom na spol bile su zabilježene u mliječnim žlijezdama štakora (atrofija kod mužjaka i lobularna hiperplazija kod ženki).
Injury, poisoning and procedural complications
Ozljede, trovanja i proceduralne komplikacije često: padovi
Strong inhibitors (e.g. gemfibrozil) of CYP2C8 are to be avoided or used with caution during enzalutamide treatment.
Jake inhibitore (npr. gemfibrozil) CYP2C8 treba izbjegavati ili primjenjivati s oprezom tijekom liječenja enzalutamidom.
Study results also have shown that enzalutamide and/or its metabolites are transferred to infant rat tissues via milk and subsequently eliminated.
Rezultati ispitivanja su također pokazali da se enzalutamid i/ili njegovi metaboliti prenose putem mlijeka u tkivo novookoćene mladunčadi te se naknadno eliminiraju.
Enzalutamide competitively inhibits androgen binding to androgen receptors, and consequently; inhibits nuclear translocation of activated receptors and inhibits the association of the activated androgen receptor with DNA even in the setting of androgen receptor overexpression and in prostate cancer cells resistant to anti-androgens.
Enzalutamid kompetitivno inhibira vezanje androgena na androgene receptore te posljedično inhibira translokaciju aktiviranih receptora u jezgru i inhibira povezivanje aktiviranog androgenog receptora s DNK čak i kod pretjerane izraženosti androgenih receptora i u stanicama raka prostate rezistentnima na anti-androgene.
If you take more tablets than prescribed, stop taking Xtandi and contact your doctor.
Ako uzmete više tableta nego što je propisano, prestanite uzimati Xtandi i obratite se svom liječniku.
- If you forget to take Xtandi for the whole day, take your usual dose the following day.
- Ako zaboravite uzeti Xtandi cijeli dan, uzmite uobičajenu dozu sljedećeg dana.
The mechanism by which enzalutamide may lower the seizure threshold is not known, but could be related to data from in vitro studies showing that enzalutamide and its active metabolite bind to and can inhibit the activity of the GABA-gated chloride channel.
Mehanizam kojim enzalutamid može sniziti prag napadaja nije poznat, ali može biti povezan s podacima iz ispitivanja in vitro koji su pokazali da se enzalutamid i njegov djelatni metabolit vežu za kloridni kanal GABA receptora i mogu inhibirati njegovu aktivnost.
Use of enzalutamide has been associated with seizure (see section 4.8).
Primjena enzalutamida povezana je s napadajima (vidjeti dio 4.8).
Approximately 45% of patients had measurable soft tissue disease at study entry, and 12% of patients had visceral (lung and/or liver) metastases.
Oko 45% bolesnika u trenutku uključivanja u ispitivanje imalo je mjerljivu bolest mekog tkiva, a 12% bolesnika imalo je visceralne metastaze (pluća i/ili jetra).
In the active treatment arm, Xtandi was administered orally at a dose of 160 mg daily.
U skupini s aktivnim liječenjem, Xtandi je primjenjivan peroralno u dozi od 160 mg na dan.
A prolonged time to reach steady state concentrations is however anticipated, and the time to maximum pharmacological effect as well as time for onset and decline of enzyme induction (see section 4.5) may be increased.
Ipak, predviđeno je produljeno vrijeme do postizanja koncentracije u stanju dinamičke ravnoteže, a vrijeme do maksimalnog farmakološkog učinka kao i vrijeme za početak i prekid indukcije enzima (vidjeti dio 4.5) može biti produljeno.
There are no human data on the use of Xtandi in pregnancy and this medicinal product is not for use in women of childbearing potential.
Nema podataka o primjeni lijeka Xtandi tijekom trudnoće u ljudi jer ovaj lijek nije namijenjen za primjenu u žena reproduktivne dobi.
It is unlikely that enzalutamide will be significantly removed by intermittent haemodialysis or continuous ambulatory peritoneal dialysis.
Enzalutamid se najvjerojatnije neće ukloniti u značajnoj količini povremenom hemodijalizom ili kontinuiranom ambulantnom peritonejskom dijalizom.
At the updated analysis 52% of enzalutamide-treated and 81% of placebo-treated patients had received subsequent therapies for metastatic CRPC that may prolong overall survival.
U ažuriranoj analizi 52% bolesnika liječenih enzalutamidom i 81% bolesnika liječenih placebom primilo je naknadne terapije za metastatski karcinom prostate rezistentan na kastraciju, koje mogu produljiti ukupno preživljenje.
The concomitant use of strong CYP2C8 inhibitors should be avoided if possible.
Potrebno je izbjegavati istovremenu primjenu jakih inhibitora CYP2C8, ukoliko je to moguće.
If you have a seizure, see your doctor as soon as possible.
Ako doživite napadaj, čim prije posjetite liječnika.
The soft capsules should not be chewed, dissolved or opened but should be swallowed whole with water, and can be taken with or without food.
Meke kapsule se ne smiju žvakati, otapati ni otvarati te ih treba progutati cijele s vodom, a mogu se uzimati s hranom ili bez nje.
Enzalutamide is not a substrate of the efflux transporters P-gp or BCRP.
Enzalutamid nije supstrat efluksnih prijenosnika P-gp ili BCRP.
• Hypnotics (e.g. diazepam, midazolam, zolpidem)
• hipnotike (npr. diazepam, midazolam, zolpidem)
PRES is a rare, reversible, neurological disorder which can present with rapidly evolving symptoms including seizure, headache, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension.
PRES je rijetki, reverzibilni, neurološki poremećaj koji se može manifestirati simptomima koji se brzo razvijaju a koji uključuju napadaje, glavobolju, smetenost, sljepoću i druge poremećaje vida te neurološke poremećaje, sa ili bez povezane hipertenzije.
There are two major metabolites in human plasma: N-desmethyl enzalutamide (active) and a carboxylic acid derivative (inactive).
Postoje dva glavna metabolita u ljudskoj plazmi: N-dezmetil enzalutamid (djelatni) i derivat karboksilne kiseline (nedjelatan).
The solubility of enzalutamide is increased by caprylocaproyl macrogolglycerides as emulsifier/surfactant.
Topivost enzalutamida je poboljšana kaprilokaproil makrogolgliceridima koji djeluju kao emulgator/surfaktant.
Stimulation of tumour cell growth via the androgen receptor requires nuclear localization and DNA binding.
Za stimulaciju rasta tumorskih stanica putem androgenih receptora potrebna je lokalizacija u jezgri i vezanje za DNK.
There was no protein binding displacement between enzalutamide and other highly bound medicinal products (warfarin, ibuprofen and salicylic acid) in vitro.
In vitro nije primijećeno međusobno istiskivanje s proteina između enzalutamida i drugih lijekova s visokim afinitetom vezivanja (varfarin, ibuprofen i salicilatna kiselina).
Of the 3179 patients in the controlled clinical trials who received enzalutamide, 2518 patients (79%) were 65 years and over and 1162 patients (37%) were 75 years and over.
Od 3179 bolesnika koji su u kontroliranim kliničkim ispitivanjima primali enzalutamid, 2518 bolesnika (79%) je bilo u dobi od 65 ili više godina, a 1162 bolesnika (37%) u dobi od 75 ili više godina.
Food has no clinically significant effect on the extent of absorption.
Hrana nema klinički značajnog učinka na opseg apsorpcije.
How Xtandi works
Kako Xtandi djeluje
The pharmacokinetics of enzalutamide were examined in subjects with baseline mild (N = 6), moderate (N = 8) or severe (N = 8) hepatic impairment (Child-Pugh Class A, B or C, respectively) and in 22 matched control subjects with normal hepatic function.
Farmakokinetika enzalutamida bila je provjerena u ispitanika s početnim blagim (N = 6), umjerenim (N = 8), ili teškim (N = 8) oštećenjem funkcije jetre (Child-Pugh stadij A, B, odnosno C) i u 22 usklađena kontrolna ispitanika s normalnom funkcijom jetre.
Excipient(s) with known effect Each soft capsule contains 57.8 mg of sorbitol.
Pomoćna tvar s poznatim učinkom: Jedna meka kapsula sadrži 57,8 mg sorbitola.
Enzalutamide has not been evaluated in patients with severe renal impairment (CrCL < 30 mL/min) or end-stage renal disease, and caution is advised when treating these patients.
Enzalutamid nije ispitivan u bolesnika s teškim oštećenjem funkcije bubrega (CrCL < 30 ml/min) ili završnom fazom zatajenja bubrega i savjetuje se oprez kad se liječe ti bolesnici.
Do not use this medicine after the expiry date which is stated on the cardboard wallet and outer carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskom omotu i kutiji iza oznake 'Rok valjanosti' ili 'EXP'.
The safety and efficacy of concomitant use of Xtandi with cytotoxic chemotherapy has not been established.
Sigurnost i djelotvornost istovremene primjene lijeka Xtandi i citotoksične kemoterapije nije ustanovljena.
Enzymes that may be induced include CYP3A in the liver and gut, CYP2B6, CYP2C9, CYP2C19, and uridine 5'-diphospho-glucuronosyltransferase (UGTs - glucuronide conjugating enzymes).
Enzimi koji mogu biti inducirani uključuju CYP3A u jetri i crijevima CYP2B6, CYP2C9, CYP2C19, te uridin 5'-difosfo-glukuronoziltransferazu (UGT-glukuronid konjugacijski enzimi).
Reproductive toxicology studies were not conducted with enzalutamide, but in studies in rats (4 and 26 weeks) and dogs (4, 13, and 39 weeks), atrophy, aspermia/hypospermia, and hypertrophy/hyperplasia in the reproductive system were noted, consistent with the pharmacological activity of enzalutamide.
Nisu provedena ispitivanja reproduktivne toksičnosti enzalutamida, ali u ispitivanjima na štakorima (4 i 26 tjedana) i psima (4, 13 i 39 tjedana) zabilježeni su atrofija, aspermija/hipospermija i hipertrofija/hiperplazija reproduktivnog sustava, što je sukladno farmakološkom djelovanju enzalutamida.
Posterior reversible encephalopathy syndrome
Sindrom posteriorne reverzibilne encefalopatije
The decision to continue treatment in patients who develop seizure should be taken case by case.
Odluku o nastavku liječenja u bolesnika kod kojih se pojave napadaji, potrebno je donijeti od slučaja do slučaja.
In the three clinical trials, patients received placebo in the control arm and patients were allowed, but not required, to take prednisone (maximum daily dose allowed was 10 mg prednisone or equivalent).
U svim trima kliničkim ispitivanjima bolesnici u kontrolnoj skupini primali su placebo, te je bolesnicima bilo dopušteno, ali se to nije zahtijevalo, da uzimaju prednizon (dopuštena maksimalna dnevna doza bila je 10 mg prednizona ili odgovarajućeg ekvivalenta).
The steady-state Cmin values of enzalutamide and the active metabolite in individual patients remained constant during more than one year of chronic therapy, demonstrating time-linear pharmacokinetics once steady-state is achieved.
Vrijednosti Cmin enzalutamida i njegovog djelatnog metabolita u stanju dinamičke ravnoteže kod pojedinih bolesnika ostale su konstantne tijekom više od godinu dana kronične terapije, što ukazuje na vremenski linearnu farmakokinetiku nakon postizanja stanja dinamičke ravnoteže.
39.6 (37.7, NR)
39,6 (37,7; ND)
Medicinal products with a narrow therapeutic range that are substrates for P-gp (e.g. colchicine, dabigatran etexilate, digoxin) should be used with caution when administered concomitantly with Xtandi and may require dose adjustment to maintain optimal plasma concentrations.
Lijekove s uskim terapijskim rasponom koji su supstrati P-gp (npr. kolhicin, dabigatran eteksilat, digoksin) potrebno je davati s oprezom kad se primjenjuju istovremeno s lijekom Xtandi i možda im bude potrebno prilagoditi dozu da bi se održale optimalne koncentracije u plazmi.
Additional secondary endpoints included time to first use of cytotoxic chemotherapy and chemotherapy-free survival.
Dodatne mjere sekundarnih ishoda uključivale su vrijeme do prve primjene citotoksične kemoterapije i preživljenje bez kemoterapije.
In addition to the observed improvement in overall survival, key secondary endpoints (PSA progression, radiographic progression-free survival, and time to first skeletal-related event) favoured enzalutamide and were statistically significant after adjusting for multiple testing.
Uz opaženo poboljšanje ukupnog preživljenja, ključne mjere sekundarnih ishoda (progresija bolesti prema PSA, preživljenje bez radiološke progresije bolesti i vrijeme do prvog koštanog događaja) davali su prednost enzalutamidu i bili statistički značajni nakon prilagodbe za višestruko testiranje.
(≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Kategorije učestalosti definiraju se na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznata učestalost (ne može se procijeniti iz dostupnih podataka).
Common: ischemic heart disease† Not known*: QT-prolongation (see sections 4.4 and 4.5)
Srčani poremećaji često: ishemijska bolest srca† nepoznata učestalost*: produljenje QT intervala (vidjeti dio 4.4 i 4.5)
In the controlled clinical studies, patients with prior seizure or risk factors for seizure were excluded.
Iz kontroliranih kliničkih ispitivanja isključeni su bolesnici koji su ranije imali napadaje ili su imali faktore rizika za pojavu napadaja.
Co-administration of enzalutamide has no clinically relevant effect on the pharmacokinetics of intravenous docetaxel (see section 4.5); however, an increase in the occurrence of docetaxel-induced neutropenia cannot be excluded.
Istovremena primjena enzalutamida nema klinički značajan učinak na farmakokinetiku intravenski primijenjenog docetaksela (vidjeti dio 4.5); ipak, porast učestalosti neutropenije inducirane docetakselom ne može se isključiti.
Elimination The mean apparent clearance (CL/F) of enzalutamide in patients ranges from 0.520 and 0.564 L/h.
Eliminacija Prosječni prividni klirens (CL/F) enzalutamida u bolesnika kreće se u rasponu od 0,520 do 0,564 l/sat.
The median rPFS was 19.7 months in the enzalutamide group and 5.4 months in the placebo group.
Medijan rPFS-a iznosio je 19,7 mjeseci u skupini liječenoj enzalutamidom i 5,4 mjeseci u placebo skupini.
Common: anxiety Uncommon: visual hallucination
Psihijatrijski poremećaji često: anksioznost manje često: vidne halucinacije
The effect of enzalutamide on P-gp substrates has not been evaluated in vivo; however, under conditions of clinical use, enzalutamide may be an inducer of P-gp via activation of the nuclear pregnane receptor (PXR).
P-gp nije procijenjen in vivo; međutim, u uvjetima kliničke primjene, enzalutamid može biti induktor P-gp putem aktivacije PXR (eng. nuclear pregnane receptor).
• Antibiotics (e.g. clarithromycin, doxycycline)
• antibiotike (npr. klaritromicin, doksiciklin)
In vitro data indicate that enzalutamide is not a substrate for OATP1B1, OATP1B3, or OCT1; and N-desmethyl enzalutamide is not a substrate for P-gp or BCRP.
In vitro podaci pokazuju da enzalutamid nije supstrat za OATP1B1, OATP1B3 ili OCT1; i N-dezmetil enzalutamid nije supstrat za P-gp ili BCRP.
Enzalutamide was not phototoxic in vitro.
Enzalutamid nije bio fototoksičan in vitro.
Oral absorption of film-coated enzalutamide tablets was evaluated in healthy male volunteers after a single 160 mg dose of Xtandi film-coated tablets, and pharmacokinetic modelling and simulation were used to predict the pharmacokinetic profile at steady state.
Apsorpcija enzalutamida nakon peroralne primjene filmom obloženih tableta ocjenjivala se u zdravih dobrovoljaca muškog spola nakon jedne doze Xtandi filmom obloženih tableta od 160 mg, a za predviđanje farmakokinetičkog profila u stanju dinamičke ravnoteže koristili su se farmakokinetičko modeliranje i simulacija.
- The ingredients of the soft capsule shell are gelatin, sorbitol sorbitan solution (see section 2),
- Sastojci ovojnice meke kapsule su želatina, otopina sorbitol sorbitana (vidjeti dio 2.), glicerol,
* Spontaneous reports from post-marketing experience
* Spontane prijave nakon stavljanja lijeka u promet
Effect of food on enzalutamide exposures
Učinak hrane na izloženost enzalutamidu
No clinically relevant effect of age on enzalutamide pharmacokinetics was seen in the elderly population pharmacokinetic analysis.
Nije opažen klinički važan učinak dobi na farmakokinetiku enzalutamida u analizi populacijske farmakokinetike.
If you are at higher risk of seizures, talk to your doctor.
Ako imate povećan rizik za napadaje, trebate se obratiti liječniku.
Enzalutamide (160 mg once daily) did not cause a clinically relevant change in the AUC or Cmax of caffeine (CYP1A2 substrate) or pioglitazone (CYP2C8 substrate).
Enzalutamid (160 mg jedanput na dan) nije prouzročio klinički važne promjene u AUC ili Cmax kofeina (supstrat CYP1A2) ili pioglitazona (supstrat CYP2C8).
Key secondary endpoints assessed in the study were time to PSA progression, time to first use of new antineoplastic therapy (TTA), overall survival (OS).
Ključne mjere sekundarnih ishoda koje su se ocjenjivale u ispitivanju bile su vrijeme do progresije PSA, vrijeme do prve primjene nove antineoplastične terapije, ukupno preživljenje (engl. overall survival, OS).
Groups of medicinal products that can be affected include, but are not limited to:
Skupine lijekova kod kojih može doći do interakcija uključuju, između ostalih, i sljedeće:
- Swallow the soft capsules whole with water.
Uzimanje lijeka Xtandi - Meke kapsule progutajte cijele s vodom.
- If you are allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Xtandi: - ako ste alergični na enzalutamid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Efficacy of enzalutamide was established in three randomised placebo-controlled multicentre phase 3 clinical studies [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] of patients with progressive prostate cancer who had failed androgen deprivation therapy [LHRH analogue or after bilateral orchiectomy].
Djelotvornost enzalutamida utvrđena je u trima randomiziranim, placebom kontroliranim multicentričnim kliničkim ispitivanjima faze III [MDV3100-14 (PROSPER), CRPC2 (AFFIRM), MDV3100-03 (PREVAIL)] na bolesnicima s progresivnim rakom prostate kod kojih je liječenje androgenom deprivacijom bilo neuspješno [analog LHRH ili nakon bilateralne orhidektomije].
Contains sorbitol (E420).
Sadrži sorbitol (E420).
Studies in rodents indicate that enzalutamide and its active metabolite can cross the blood brain barrier.
Ispitivanja u glodavaca pokazuju da enzalutamid i njegov djelatni metabolit mogu prijeći krvno-moždanu barijeru.
The median age was 69 years (range 41 - 92) and the racial distribution was 93% Caucasian, 4% Black, 1% Asian, and 2% Other.
Medijan dobi iznosio je 69 godina (raspon 41 - 92), a rasna raspodjela bila je 93% bijelaca, 4% crnaca, 1% azijata i 2% drugih rasa.
The median age was 71 years (range 42 - 93) and the racial distribution was 77% Caucasian, 10% Asian, 2% Black and 11% other or unknown races.
Medijan dobi iznosio je 71 godinu (u rasponu 42 - 93), a distribucija prema rasi bila je 77% bijele rase, 10% azijati, 2% crne i 11% druge ili nepoznate rase.
Xtandi is for oral use.
Xtandi je namijenjen za peroralnu primjenu.
• Calcium channel blockers (e.g. diltiazem, felodipine, nicardipine, nifedipine, verapamil)
• blokatore kalcijevih kanala (npr. diltiazem, felodipin, nikardipin, nifedipin, verapamil)
Post-authorisation efficacy study (PAES): In order to investigate the long-term effects of enzalutamide on Overall Survival and relevant secondary endpoints in adult men with high-risk non-metastatic castration-resistant prostate cancer, the MAH should submit the results of the MDV3100-14 (PROSPER) efficacy study:
Ispitivanje djelotvornosti lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PAES): Radi ispitivanja dugoročnog učinka enzalutamida na ukupno preživljenje i važne mjere sekundarnih ishoda kod odraslih muškaraca s visokorizičnim nemetastatskim rakom prostate rezistentnim na kastraciju, nositelj odobrenja treba predati rezultate ispitivanja djelotvornosti MDV310014 (PROSPER).