ODM-201 maintenance therapy in patients with metastatic castration resistant prostate cancer (mCRPC) previously treated with novel hormonal agents and non-progressive disease after subsequent treatment with a taxane: A multicenter randomized double-blind placebo-controlled phase II trial - Protocol SAKK 08/16

SAKK0 个研究点目标入组 88 人开始时间: 2019年1月22日最近更新: 2019年2月28日

试验速览

暂无简介。

•- 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
•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
•- 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)

发起方

SAKK