Hormone Therapy Followed By Internal Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer
A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining hormone therapy with internal radiation may be effective in treating locally recurrent prostate cancer.
PURPOSE: Phase II trial to study the effectiveness of hormone therapy followed by internal radiation in treating patients who have locally recurrent prostate cancer following external-beam radiation therapy.
研究概览
详细说明
OBJECTIVES:
- Determine the nature, intensity, and time course of health-related quality of life changes in patients with locally recurrent prostate adenocarcinoma treated with androgen suppression and transperineal ultrasound-guided brachytherapy after external beam radiotherapy.
- Determine the morbidity of patients treated with this regimen.
- Determine the overall survival, disease-free survival, and disease-specific survival of patients treated with this regimen.
- Determine the clinical patterns of tumor recurrence (i.e., time to local tumor progression or distant failure) and time to biochemical failure of patients treated with this regimen.
- Determine the post-brachytherapy dosimetric coverage of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive androgen suppression comprising goserelin subcutaneously (as either 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection) OR leuprolide intramuscularly (as 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection or 1 four-month depot injection) AND oral flutamide 3 times daily for 112 days OR oral bicalutamide once daily for 112 days.
Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled to 2 different cohorts of brachytherapy.
- Cohort 1: Patients undergo initial-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103.
- Cohort 2: After a minimum of 1-year follow-up for all patients in cohort 1, if tolerance is acceptable, additional patients undergo higher-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103.
Quality of life is assessed at baseline, within 2 weeks prior to brachytherapy, every 3 months for 1 year, and then every 6 months for 2 years.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 83-166 patients (83 per cohort) will be accrued for this study within 1.5-3 years.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
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Arizona
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Scottsdale、Arizona、美国、85259-5404
- CCOP - Scottsdale Oncology Program
-
-
Florida
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Jacksonville、Florida、美国、32224
- Mayo Clinic
-
-
Illinois
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Urbana、Illinois、美国、61801
- CCOP - Carle Cancer Center
-
-
Iowa
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Des Moines、Iowa、美国、50309-1016
- CCOP - Iowa Oncology Research Association
-
-
Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic Cancer Center
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Nebraska
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Omaha、Nebraska、美国、68106
- CCOP - Missouri Valley Cancer Consortium
-
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15212-4772
- Allegheny General Hospital
-
-
Wisconsin
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Green Bay、Wisconsin、美国、54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed locally recurrent or persistent prostate adenocarcinoma
- Locally recurrent disease
- Prostate-specific antigen (PSA) no greater than 10 ng/mL
N0 and M0 (at time of initial diagnosis and at time of local recurrence)
- Lymph nodes must be negative or will be negative after nodal sampling or dissection
- More than 18 months after completion of prior external beam radiotherapy
Must have had 1 of the following disease characteristics prior to external beam radiotherapy:
- T1-2a, Gleason score 2-6, and PSA no greater than 15 ng/mL
- T1-2a, Gleason score 7, and PSA no greater than 4 ng/mL
- T2b, Gleason score 2-6, and PSA no greater than 6 ng/mL
- Must have American Urological Association Symptom Index score no greater than 15
- Transrectal ultrasound-determined prostate planimetry volume no greater than 60 mL
- No pubic arch interference of more than 1/3 the prostatic volume determined by transrectal ultrasound or pelvic CT scan
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Zubrod 0-1 OR
- ECOG 0-1
Life expectancy:
- At least 5 years
Other:
- No persistent late intestinal or bladder toxicity grade 2 or greater
- No other major medical or psychiatric illness that would preclude study
- No metallic hip prosthesis
- No other malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
- No other concurrent illness that would limit life expectancy
- Suitable for spinal or general anesthesia
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Chemotherapy:
- No prior chemotherapy for prostate cancer
Endocrine therapy:
- At least 12 months since prior androgen suppression except goserelin or leuprolide with flutamide or bicalutamide begun within the past 30 days
Radiotherapy:
- See Disease Characteristics
- No prior external beam radiotherapy doses exceeding 71 Gy to the prostate
- No prior radionuclide prostate brachytherapy
Surgery:
- No prior transurethral prostate resection
- No prior prostatectomy or prostatic cryosurgery
- No prior bilateral orchiectomy
Other:
- No concurrent participation in another medical research study for prostate cancer treatment
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:brachytherapy + radiation
Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled to 2 different cohorts of brachytherapy. Cohort 1: Patients undergo initial-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Cohort 2: After a minimum of 1-year follow-up for all patients in cohort 1, if tolerance is acceptable, additional patients undergo higher-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Quality of life is assessed at baseline, within 2 weeks prior to brachytherapy, every 3 months for 1 year, and then every 6 months for 2 years. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
生活质量
大体时间:长达 10 年
|
长达 10 年
|
次要结果测量
结果测量 |
大体时间 |
---|---|
无病生存
大体时间:长达 10 年
|
长达 10 年
|
发病率
大体时间:长达 10 年
|
长达 10 年
|
Disease specific survival
大体时间:Up to 10 years
|
Up to 10 years
|
tumor recurrence
大体时间:Up to 10 years
|
Up to 10 years
|
合作者和调查者
调查人员
- 学习椅:Thomas M. Pisansky, MD、Mayo Clinic
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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