ODM-201 maintenance therapy in patients with mCRPC previously treated with novel hormonal agents
- Conditions
- Metastatic castration resistant prostate cancerMedDRA version: 20.0Level: LLTClassification code 10007453Term: Carcinoma of the prostate metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2016-003996-23-IT
- Lead Sponsor
- SAKK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 88
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
? 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>disease after chemotherapy with a taxane;Secondary Objective: ;Primary end point(s): Radiographic progression-free survival<br>(rPFS) at 12 weeks after treatment start;Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Fatigue;Timepoint(s) of evaluation of this end point: Day 1 of each cycle