Stereotactic Radiotherapy for Oligometastatic Prostate Cancer (CROP)
Comprehensive Stereotactic Radiotherapy for Oligometastatic Prostate Cancer: A Phase I/II Study
연구 개요
상세 설명
Patients will receive androgen deprivation therapy (ADT) for a minimum of 1 year. After this, an intermittent hormone therapy approach will be taken, where ADT will not be restarted until the prostate specific antigen (PSA) reaches a minimum of 10-15 ng/mL. Lupron 30 mg IM will be delivered every 4 months when on ADT.
The prostate (if not previously treated) will be treated to a dose of 35-40 Gy in 5 fractions. All visible nodal metastases will be treated to a dose of 30-35 Gy in 5 fractions. It is very likely that nodal metastases will shrink significantly (often completely) with ADT. In this scenario, the involved nodal regions will be treated to a more modest dose of 25 Gy in 5 fractions (roughly equivalent to a dose of 46 Gy in 23 fractions assuming an α/β value of 1.4). Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Metastases in the brain, spine, lung, liver, and adrenal will be treated according to established stereotactic radiotherapy (SRT) policies at Sunnybrook Odette Cancer Centre. Comprehensive SRT should be delivered within 3 months of starting ADT.
During any "off" period of ADT (before the PSA rises above 10-15 ng/mL), comprehensive SRT can be repeated if there are new oligometastases that become visible. One month after initiation comprehensive SRT, patients will be contacted to assess for acute toxicities.
After completion of radiotherapy to all disease sites, patients will be followed every 3-4 months with PSA testing until the development of castrate resistant prostate cancer. At the same time points, late toxicity and quality of life will be collected for a minimum of 2 years. Computed tomography (CT) of the chest/abdo/pelvis +/- magnetic resonance imaging (MRI) of previously irradiated body sites and bone scan will be performed whenever the PSA reaches ≥ 10 ng/mL (prior to re-starting androgen deprivation therapy during intermittent hormone therapy approach), or at a minimum frequency of once per year.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook Odette Cancer Centre
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참여기준
자격 기준
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연구 대상 성별
설명
Inclusion Criteria:
- Able to provide informed consent.
- ECOG performance status 0-1.
- Histologic confirmation of prostate adenocarcinoma.
- Stage IV disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes.
- ≤ 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases).
- All sites of disease are amenable to stereotactic radiotherapy.
Exclusion Criteria:
- Castrate resistant prostate cancer.
- Evidence of spinal cord compression.
- Previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy).
- Inability to safely treat all sites of visible disease.
- Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Stereotactic radiotherapy
Stereotactic radiotherapy will be delivered to the prostate (if not previously treated) and to all metastatic tumours.
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Patients will receive ADT for a minimum of 1 year. After this, an intermittent hormone therapy approach will be taken. The prostate (if not previously treated) will be treated to a dose of 35-40 Gy in 5 fractions. All visible nodal metastases will be treated to a dose of 30-35 Gy in 5 fractions. Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Metastases in the brain, spine, lung, liver, and adrenal will be treated according to established SRT policies at the Sunnybrook Odette Cancer Centre. Comprehensive SRT should be delivered within 3 months of starting ADT.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence of late radiotherapy toxicities after stereotactic radiotherapy to all sites of disease
기간: cumulative incidence at 2 years
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common terminology criteria for adverse events (CTCAE) version 4.0
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cumulative incidence at 2 years
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2차 결과 측정
결과 측정 |
기간 |
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Quality of Life (EORTC QLQ-C30)
기간: proportion of patients who experience a significant decline in quality of life at 6 months, 12 months, 18 months, and 24 months
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proportion of patients who experience a significant decline in quality of life at 6 months, 12 months, 18 months, and 24 months
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Time to development of castrate resistant prostate cancer
기간: through study completion, an average of 2 years
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through study completion, an average of 2 years
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Radiographic local control of irradiated tumours
기간: actuarial rate at 2 years
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actuarial rate at 2 years
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Radiographic "distant" control rate
기간: actuarial rate at 2 years
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actuarial rate at 2 years
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Overall survival
기간: through study completion, an average of 4 years
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through study completion, an average of 4 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Patrick Cheung, M.D., Toronto Sunnybrook Regional Cancer Centre
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
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