A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer. - PROSTY trial

All-Ireland Cooperative Oncology Research Group0 个研究点目标入组 360 人开始时间: 2006年8月17日最近更新: 2021年5月10日

适应症

试验速览

暂无简介。

•Inclusion Criteria:
•(1) Histologically/ cytologically proven adenocarcinoma of prostate.
•(2) Metastatic disease (confirmed by imaging or clinical examination)
•(3) Hormone refractory prostate cancer defined as rising PSA values in 2 sequential measurements
•(4) Testosterone levels must be within the institutions castration levels.
•(5) PSA > 10 µg/l
•(6) No previous cytostatic treatment except estramustine phosphate which should be stopped =3 weeks before starting trial medication.
•(7) Anti-androgen treatment must be stopped =3 weeks before starting trial medication.
•(8) WHO performance status < or = 2
•(9) Age > 18 years
•(10) Laboratory requirements :
•(a) Haematology :
•- neutrophils > or = 1.5 x 10 to the power of 9 /l
•- hemoglobin > or = 110 g/l , HB > 100 g/l in Sweden
•- platelets > or = 100 x 10 to the power of 9 /l
•(b) Hepatic function :
•- total bilirubin < or = 1 x UNL
•- ALAT and ASAT < or = 2.5 x UNL, Alk. Phos < or = 6 x UNL. In the presence of extensive bone disease, Alk. Phos is > 6 x UNL, the patient should be eligible in the study.
•(c) Renal function :
•-Creatinine < or = 1.5 x UNL (ie NCI grade < or = 1)
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Exclusion Criteria:
•(1) Less than 4 weeks since the completion of surgery.
•(2) Prior radiotherapy > 25% of bone marrow
•(3) Less than 3 weeks since estramustine phosphate treatment
•(4) Prior therapy with radioisotopes
•(5) Other malignant disease/ malignancy (except basalioma) within the past 5 years.
•(6) Serious liver disease
•(7) Other serious illness or medical condition:
•(a)Serious cardiac disease; ischemic or tromboembolic cardiac disease, pulmonary emboli, cardiac infarction within 12 months
•(b)Active infection
•(c)Active peptic ulcer, unstable diabetes mellitus or other contraindications for the use of
•corticosteroids.
•(d)Auto-immune disease (lupus, scleroderma, rheumatoid polyarthritis)

发起方

All-Ireland Cooperative Oncology Research Group