Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 966
- 试验地点
- 34
研究概览
简要总结
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin may fight prostate cancer by reducing the production of androgens.
PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression.
详细描述
OBJECTIVES:
- Determine the best hormonal scheme to be associated with pelvic radiotherapy in the curative management of prostatic carcinoma for hormonal treatment with regards to treatment outcome (overall survival, clinical disease free survival, local regional control), quality of life (treatment side effects, sexual function), and health economy (cost effectiveness ratio).
OUTLINE: This is a randomized, multicenter study.
Patients receive external radiation for 5 weeks, followed by a pelvic boost given for 2 weeks and a 6 month combined androgen blockage initiated at the onset of external irradiation. Flutamide (Eulexin) or bicalutamide (Casodex) may be used as the antiandrogens. Antiandrogen treatment starts 1 week before the first injection of triptorelin.
Patients are then randomized to one of two treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •T1c-T2a-b, N1-2 or pN1-2 (after pelvic lymphadenectomy)
- •T2c-T4, N0-2
- •Prior external radiotherapy for locally advanced prostatic carcinoma required
- •Prior hormone therapy (6 months of combined androgen blockade) for locally advanced prostatic carcinoma required with PSA no greater than 150 ng/mL before administration
- •No progressive disease after the 6 months of combined androgen blockage
- •No stages T1c/T2a-b with a negative pelvic lymph nodes status that is assessed clinically or surgically
- •No lymph node involvement to common iliac and/or periaortic lymph nodes (M1a)
- •No external iliac lymph node metastasis more than 5 cm in greatest dimension (N3)
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 5 years
- •Hematopoietic:
- •Hemoglobin at least 10 g/dL
- •WBC at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Not specified
- •Not specified
- •No prior or concurrent cancers other than basal cell skin cancer
- •No serious nonmalignant disease resulting in a life expectancy of less than 5 years
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior biologic therapy for prostate cancer
- •Chemotherapy
- •No prior chemotherapy for prostate cancer
- •Endocrine therapy
- •See Disease Characteristics
- •Radiotherapy
- •See Disease Characteristics
- •See Disease Characteristics
排除标准
- 未提供