Metastatic castration resistant prostate cancer MedDRA version: 20.0 Level: LLT Classification code 10007453 Term: Carcinoma of the prostate metastatic System Organ Class: 100000004864
Conditions
Interventions
Product Name: ODM-201
Product Code: ODM-201
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BAY 1841788
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
SAKK
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate ? Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists) ? Metastatic disease, documented by imaging ? Total testosterone = 50 ng/dL (= 1.7 nmol/L) ? Treatment with abiraterone OR enzalutamide for at least 8 weeks prior to taxane based chemotherapy ? No evidence of disease progression after chemotherapy with docetaxel (cumulative dose of = 450 mg/m2 or total dose =900mg) or cabazitaxel (cumulative dose of =120 mg/m2 or total dose =204 mg) o No evidence of progression on imaging1 according to PCWG3 o No evidence of progression on PSA levels referred to the nadir since start of taxane treatment (PSA progression defined as >25% increase of PSA level or >50% if PSA decrease under chemotherapy >50% AND > 5 ng/mL increase in the absolute PSA value) ? Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial ? Planned start of trial treatment 2 to 8 weeks after last taxane dose ? Male patient 18 years or older ? WHO performance status of =2 Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: ? Prior chemotherapy for prostate cancer except from chemotherapy with a taxane ? Retreatment with a taxane for metastatic castration resistant prostate cancer after interruption of > 8 weeks ? Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10 mg prednisone per day ? Known CNS or leptomeningeal metastases ? Clinical or radiological evidence of current spinal cord compression ? Presence of a small cell component ? History of hematologic or primary solid tumor malignancy, unless in remission for at least 2 years from registration with the exception of localized non-melanoma skin cancer or carcinoma in situ having undergone complete resection. ? Prior therapy for mCRPC with modern anti-hormonal treatment except for enzalutamide or abiraterone ? Concurrent treatment with other experimental drugs ? Concomitant use of other anti-cancer drugs ? Severe or uncontrolled cardiovascular disease ? Acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before expected start of treatment ? Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information ? Known hypersensitivity to trial drug(s) or to any component of the trial drug(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane;Secondary Objective: ;Primary end point(s): Radiographic progression-free survival (rPFS) at 12 weeks after treatment start;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Fatigue;Timepoint(s) of evaluation of this end point: Day 1 of each cycle | — |
Countries
France, Italy, Spain, Switzerland
Outcome results
None listed