A Feasibility Study of Oral Hormonal Therapy and Radiation for Non-metastatic, Intermediate or High Risk Prostate Cancer in Men 70 and Older or With Medical Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire
研究概览
简要总结
The purpose of this study is see if quality of life is improved in patients receiving oral hormone therapy compared to standard of care. The study will also compare survival rates between patients receiving oral hormone therapy and those receiving standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age > or = 70 years and/or Charlson comorbidity index score > or = 2
- •Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma
- •Two or more of the following intermediate risk features for recurrence, Gleason Score = 7, PSA 10-20 ng/ml, Clinical Stage T2b-T2c Percent positive biopsy cores > or = 50%
- •One or more of the following high risk features for recurrence, Gleason Score 8-10, PSA > 20 ng/ml, Clinical Stage T3a-T4
- •Clinically negative lymph nodes as established by imaging, nodal sampling, or dissection
- •No evidence of bone metastases on bone scan
- •History/physical examination via the Charlson Comorbidity Index within 60 days prior to registration
- •Zubrod Performance Status 0-2
- •Age > or = 18
- •Baseline serum PSA within 60 days prior to registration
- •Baseline serum testosterone obtained within 60 days prior to registration
- •Study entry PSA and serum testosterone must not be obtained during the following time frames, 10-day period following prostate biopsy, following initiation of oral androgen manipulation, within 30 days after discontinuation of finasteride or dutasteride
- •CBC/ differential obtained within 60 days prior to registration with adequate bone marrow function
- •Patient must be able to provide study-specific informed consent prior to study entry
- •Liver function parameters as follows, Total Bilirubin < or = 2 x institutional upper limit of normal, AST (SGOT) or ALT (SGPT) < or = 2 x institutional upper limit normal
排除标准
- •Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
- •Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
- •Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically prescribed for the treatment of prostate cancer
- •Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted
- •Prior radiation, including brachytherapy, to the region of the prostate that would result in overlap of RT fields
- •Active lupus or scleroderma
- •Severe, active co-morbidity, including but not limited to,unstable angina within the last 6 months without subsequent corrective cardiovascular procedure,or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Hepatic insufficiency with AST, ALT, or Bilirubin > 2 x upper limit of normal,clinical jaundice, and/or coagulation defects
- •Acquired Immune Deficiency Syndrome (AIDS); note, however, that HIV testing is not required for entry into this protocol.Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation
研究组 & 干预措施
Oral Androgen Therapy
Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)
干预措施: Bicalutamide (Drug)
Oral Androgen Therapy
Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)
干预措施: Dutasteride (Drug)
Oral Androgen Therapy
Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)
干预措施: Finasteride (Drug)
Oral Androgen Therapy
Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)
干预措施: Radiation (Radiation)
结局指标
主要结局
Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire
时间窗: Baseline, 6 months, and 24 months
Questionnaires were completed in writing by the patient. Questionnaires were administered at 1-2 months after initiation of hormonal treatment (before RT), at 3-4 months (during RT), and at 6 months after initiation of study therapy. Patients also completed questionnaires at 12, 18, and 24 months after completion of radiation therapy. Of primary interest were the baseline and 6 month and 24 month timepoints which are reported here. Scale scores could range from 0-100, with higher scores indicating better quality of life.
次要结局
- Percentage of Participants Free From Biochemical Failure(4 years)