Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- PSA 3 and 6 months following implantation then every 6 months.
研究概览
简要总结
Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.
详细描述
In calender year 2005, 220, 000 men will be diagnosed with prostate cancer and approximately 30,000 will subsequently die of metastatic disease. Although the vast majority of men will be diagnosed with clinically localized and potentially curable disease, the selection of one local modality over another remains a focus of significant controversy within the uro-oncology community. However, patients with higher risk features are most often managed with radiotherapeutic approaches to include androgen deprivation therapy.
Prostate brachytherapy represents the ultimate-three dimensional conformal therapy and permits dose escalation far exceeding other modalities. Following permanent prostate brachytherapy with or without supplemental external beam radiation therapy, favorable long-term biochemical outcomes have been reported for patients with low, intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities (1,2).
Several prospective randomized trials have demonstrated that androgen deprivation therapy in conjunction with conventional doses of external beam radiation therapy (65-70 Gy)results in improvement in disease-free and overall survival in patients with locally advanced prostate cancer (3,4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •High risk patients - Two to three of the following: PSA 10-30 ng/mL, Gleason score greater than or equal to 6, clinical stage greater than or equal to T2c (2002 ACJJ).
- •CT of the abdomen and pelvis and bone scan without evidence of metastases.
- •An enzymatic prostatic acid phosphatase must be obtained prior to randomization.
- •A serum testosterone must be obtained prior to initiation of androgen deprivation therapy.
- •No prior pelvic external beam radiation therapy for prostate cancer or other malignancies.
- •No prior androgen deprivation therapy.
- •Minimum 5 year life expectancy.
- •No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years.
排除标准
- •Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.
研究组 & 干预措施
no hormones
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with no hormones
干预措施: External beam radiation (Radiation)
9 months of hormone therapy
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with a 9 month course of hormone therapy
干预措施: External beam radiation (Radiation)
9 months of hormone therapy
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with a 9 month course of hormone therapy
干预措施: Lupron (Drug)
9 months of hormone therapy
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with a 9 month course of hormone therapy
干预措施: Casodex (Drug)
结局指标
主要结局
PSA 3 and 6 months following implantation then every 6 months.
时间窗: 3 and 6 months following implantation then every 6 months
PSA 3 and 6 months following implantation then every 6 months.
Serum testosterone levels at 3 and 6 months in hormonally manipulated patients.
时间窗: 3 and 6 months
Serum testosterone levels at 3 and 6 months in hormonally manipulated patients
Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.
时间窗: as needed
Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.
次要结局
- EPIC on 6 and 12 months and then annually.(6 and 12 months and then annually.)
- Hormonally manipulated patients will obtain a DEXA scan.(as needed)
- For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.(every 3 months is recommended.)
研究者
Gregory Merrick, M.D.
Medical Director
Schiffler Cancer Center