Repeated Rhenium-188-HEDP versus Radium-223-chloride in patients with metastatic castration-resistant prostate cancer; the RARE trial - RaRe

VU University Medical Center0 个研究点目标入组 402 人开始时间: 2018年2月22日最近更新: 2018年6月5日

研究概览

暂无简介。

•Male, 18 years and older.
•Histologically confirmed prostate cancer
•Bone metastases (=6 lesions) showing pathological uptake at bone scintigraphy
•WHO performance status of =2.
•Life expectancy of at least 6 months.
•Castration-resistant disease: serum testosterone level of =1.7 nmol per liter (=50 ng per deciliter) after bilateral orchiectomy or during maintenance treatment consisting of androgen-ablation therapy with a luteinizing hormone-releasing hormone agonist. During study treatment the maintenance androgen-deprivation therapy must be continued.
•Baseline PSA =5 ng/ml with evidence of progressively increasing PSA values (two consecutive increases over the previous reference value with at least a 1-week interval).
•Symptomatic disease with either regular use of analgesic medication or treatment with external-beam radiotherapy for cancer-related bone pain within the previous 12 weeks.
•Progression on or after treatment with docetaxel, or inability to receive docetaxel.
•Adequate renal function (serum creatinine level =1.5 x ULN)
•Adequate hematological function defined as absolute neutrophil count =1.5 x 109/L and platelet count =100 x 109/L, hemoglobin =6.0 mmol/L
•Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 252

•Treatment with chemotherapy within the previous 4 weeks
•Previous hemibody external radiotherapy.
•Systemic radiotherapy with radioisotopes within the previous 24 weeks.
•Malignant lymphadenopathy =3cm in the short-axis diameter.
•Presence of visceral metastases.
•Imminent or established spinal cord compression.
•Active uncontrolled bacterial, viral or fungal infection.
•History of another malignancy within the last five years except adequately treated basal cell carcinoma of the skin.
•Organ allografts requiring immunosuppressive therapy
•Any serious uncontrolled concomitant disease.
•Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

发起方

VU University Medical Center