Health conditions
(Source de données: WHO)
-C61 Malignant neoplasm of prostate
Malignant neoplasm of prostate;C61 ;Malignant neoplasm of prostate
Interventions (Source de données: WHO)
Investigational product, dose and mode of administration: ODM-201 600 mg or placebo (2 x 300 mg tablets) bid orally with food.
Duration of treatment: Until confirmed metastasis or until death up to 72 months (6 years).
The study treatment will be given in conjunction with the current hormonal treatment, if such treatment has been prescribed to participants. The cost of that treatment will be covered by Sponsor.
Inclusion/Exclusion Criteria
(Source de données: WHO)
Gender: Male
Maximum age: 99
Minimum age: 18
Inclusion criteria:
Among inclusion criteria are the following, please refer to the protocol for the rest of criteria:
1.Written informed consent obtained.
2.Males aged 18 years.
3.Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
4.Progressive castration-resistant prostate cancer is defined as 3 consecutive rising PSA level during androgen deprivation therapy (ADT) at least 1 week apart, resulting in 2 > 50% increases over nadir, with the last value 2 ng/ml despite castrate level of serum testosterone. If the patient has a history of antiandrogen use, the most recent PSA value must be obtained at least 4 weeks after antiandrogen withdrawal.
5.Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on gonadotropin releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy. Patients who have not undergone bilateral orchiectomy must continue GnRH therapy during the study.
6.PSADT of 10 months and PSA 2 ng/ml at screening.
7.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion criteria:
Among exclusion criteria are the following, please refer to the protocol for the rest of criteria:
1.History of metastatic disease or presence of detectable metastases by blinded central reading. Presence of pelvic lymph nodes < 2 cm in short axis below the aortic bifurcation is allowed.
2.Symptomatic local-regional disease that requires medical intervention including moderate/severe urinary obstruction or hydronephrosis due to prostate cancer
3.Acute toxicities of prior treatments and procedures not resolved to grade 1 or baseline before randomisation.
4.Prior treatment with:
?second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, ODM-201, other investigational AR inhibitors,
?CYP17 enzyme inhibitor such as abiraterone acetate, TAK-700 or
?oral ketoconazole longer than for 28 days.
5.Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride) or AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate) within 28 days before randomisation.
6.Prior chemotherapy or immunotherapy for prostate cancer, except adjuvant/neoadjuvant treatment completed > 2 years before randomisation.
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Plus d’informations sur l’étude
Date d’enregistrement de l’étude
29 avr. 2015
Intégration du premier participant
9 avr. 2015
Statut de recrutement
Complete
Titre scientifique
(Source de données: WHO)
A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF ODM-201 IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Type d’étude
(Source de données: WHO)
Interventional
Conception de l’étude
(Source de données: WHO)
This is a randomised, phase III, multicentre, double-blind, placebo-controlled efficacy and safety study of oral ODM-201 in patients with nmCRPC who are at high risk for developing metastatic disease. The study has a design of 2 parallel groups and consists of 2 periods: a study treatment period and a follow-up period.
All eligible patients will be randomised to receive 600 mg of ODM-201 twice a day (bid) or placebo in a 2:1 ratio in a double-blind manner. Randomisation will be stratified by PSA doubling time (PSADT; 6 months vs. > 6 months) and use of osteoclast-targeted therapy (yes vs. no).
The study treatment will be given in conjunction with the current hormonal treatment, if such treatment has been prescribed to participants. The cost of that treatment will be covered by Sponsor.
Phase
(Source de données: WHO)
III
Contact pour informations
(Source de données: WHO)
ORION CORPORATION, ORION PHARMA
Résultats de l’étude
(Source de données: WHO)
Résumé des résultats
pas encore d’informations disponibles
Lien vers les résultats dans le registre primaire
pas encore d’informations disponibles
Informations sur la disponibilité des données individuelles des participants
pas encore d’informations disponibles
Lieux de réalisation des études
Pays où sont réalisées les études
(Source de données: WHO)
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Finland, France, Germany, Greece, Hungary, Israel, Italy, Korea South, Latvia, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kindgdom, United States
Contact pour plus d’informations sur l’étude
Contact pour des informations générales
(Source de données: WHO)
Rosa
Chamorro
Calle Amador Merino Reyna N? 223 Int. 802, Urb. Jardin
BAYER S.A.
202 5636, 985 630 426
rosa.chamorro@iconplc.com
Contact pour des informations scientifiques
(Source de données: WHO)
Rosa
Chamorro
Calle Amador Merino Reyna N? 223 Int. 802, Urb. Jardin
BAYER S.A.
202 5636, 985 630 426
rosa.chamorro@iconplc.com
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