Health conditions
(Datenquelle: WHO)
-C61 Malignant neoplasm of prostate
Malignant neoplasm of prostate;C61 ;Malignant neoplasm of prostate
Interventions (Datenquelle: 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
(Datenquelle: 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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Weitere Informationen zur Studie
Datum der Studienregistrierung
29.04.2015
Einschluss der ersten teilnehmenden Person
09.04.2015
Rekrutierungsstatus
Complete
Wissenschaftlicher Titel
(Datenquelle: 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
Studientyp
(Datenquelle: WHO)
Interventional
Design der Studie
(Datenquelle: 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
(Datenquelle: WHO)
III
Kontakt für Auskünfte
(Datenquelle: WHO)
ORION CORPORATION, ORION PHARMA
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Link zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsländer
(Datenquelle: 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
Kontakt für weitere Auskünfte zur Studie
Kontakt für allgemeine Auskünfte
(Datenquelle: 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
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: 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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