ODM-201 maintenance therapy in patients with mCRPC previously treated with novel hormonal agents

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 92

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 AND/OR enzalutamide for at least 8 weeks prior to taxane based chemotherapy
- No evidence of disease progression after chemotherapy with docetaxel (at least cumulative dose of = 300 mg/m2 or total dose =600mg) or cabazitaxel (at least cumulative dose of =80 mg/m2 or total dose =160 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
- Patients having provided written informed consent prior to any study-related
procedures.
- Patients must have national social insurance coverage.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Prior chemotherapy for prostate cancer except from chemotherapy with a taxane
- 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)
- Persons deprived of their liberty or under protective custody or guardianship.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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