- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00032006
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Arizona
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Scottsdale, Arizona, 미국, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic
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Illinois
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Urbana, Illinois, 미국, 61801
- CCOP - Carle Cancer Center
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Iowa
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Des Moines, Iowa, 미국, 50309-1016
- CCOP - Iowa Oncology Research Association
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
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Nebraska
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Omaha, Nebraska, 미국, 68106
- CCOP - Missouri Valley Cancer Consortium
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15212-4772
- Allegheny General Hospital
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Wisconsin
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Green Bay, Wisconsin, 미국, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
삶의 질
기간: 최대 10년
|
최대 10년
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
무질병 생존
기간: 최대 10년
|
최대 10년
|
병적 상태
기간: 최대 10년
|
최대 10년
|
Disease specific survival
기간: Up to 10 years
|
Up to 10 years
|
tumor recurrence
기간: Up to 10 years
|
Up to 10 years
|
공동 작업자 및 조사자
수사관
- 연구 의자: Thomas M. Pisansky, MD, Mayo Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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