- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00255606
Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer
A Phase III Trial Comparing Docetaxel Every Third Week to Biweekly Docetaxel Monotherapy in Metastatic Hormone Refractory Prostate Cancer Patients - PROSTY Trial
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of docetaxel and prednisone is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and prednisone to compare how well they work in treating patients with metastatic prostate cancer.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Compare the time to treatment failure in patients with hormone-refractory metastatic prostate cancer treated with two different schedules of docetaxel in combination with prednisone.
Secondary
- Compare overall survival of patients treated with these regimens.
- Compare the response rate in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the need for epoetin beta in patients treated with these regimens.
- Determine the effect of epoetin beta on hemoglobin response rate, transfusion rate, and quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on days 1 and 15 and oral prednisone once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive docetaxel IV over 1 hour on day 1 and prednisone once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients who experience anemia (hemoglobin < 11 g/dL) receive epoetin beta subcutaneously once weekly during chemotherapy.
Quality of life is assessed at baseline, every 6 weeks during study treatment, at completion of study treatment, and then every 2 months thereafter.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 360 patients (180 per treatment arm) will be accrued for this study within 4 years.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
-
Karlstad, 스웨덴, 65185
- Karlstad Central Hospital
-
Stockholm, 스웨덴, S-171 76
- Karolinska University Hospital - Solna
-
-
-
-
-
Cork, 아일랜드
- Bons Secours Hospital
-
Cork, 아일랜드
- Mercy University Hospital
-
Dublin, 아일랜드, 9
- Beaumont Hospital
-
Dublin, 아일랜드, 7
- Mater Misericordiae University Hospital
-
Dublin, 아일랜드, 24
- Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
-
Dublin, 아일랜드, 8
- St. James's Hospital
-
Galway, 아일랜드
- Galway University Hospital
-
Limerick, 아일랜드, 0009
- Mid-Western Cancer Centre at Mid-Western Regional Hospital
-
-
-
-
-
Helsinki, 핀란드, FIN-00029
- Helsinki University Central Hospital
-
Kajaani, 핀란드, 87140
- Kainuu Central Hospital
-
Kokkola, 핀란드, 67200
- Keski-Pohjanmaa Central Hospital
-
Kotka, 핀란드, 48210
- Kymenlaakso Central Hospital
-
Lahti, 핀란드, 15850
- Tampere University Hospital
-
Oulu, 핀란드, FIN-90014
- Oulu University Hospital
-
Pori, 핀란드, 28500
- Satakunta Central Hospital
-
Tampere, 핀란드, 33521
- Tampere University Hospital
-
Turku, 핀란드, FIN-20521
- Turku University Central Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the prostate
- Metastatic disease by imaging or clinical examination
- Hormone-refractory disease, defined as prostate-specific antigen (PSA) level > 10 µg/L AND rising between 2 sequential measurements
- Testosterone within castration levels by orchiectomy or medical castration comprising luteinizing hormone-releasing hormone (LHRH) analogues
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Neutrophil count ≥ 1,500/mm^3
- Hemoglobin ≥ 11.0 g/dL
- Platelet count ≥ 100,000/mm^3
Hepatic
- ALT and AST ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin normal
- Alkaline phosphatase ≤ 6 times ULN (unless due to the presence of extensive bone disease)
- No serious liver disease
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No ischemic or thromboembolic cardiac disease
- No myocardial infarction within the past 12 months
- No other serious cardiac disease
Pulmonary
- No pulmonary emboli
Immunologic
- No active infection
No autoimmune disease, including any of the following:
- Lupus
- Scleroderma
- Rheumatoid polyarthritis
Other
- No active peptic ulcer
- No unstable diabetes mellitus
- No contraindication to corticosteroids
- No other malignant disease within the past 5 years except basalioma
- No functional iron deficiency (i.e., transferrin saturation < 20%) that cannot be treated with iron supplementation
- No other serious illness or medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 2 months since prior recombinant human epoetin alfa or any other erythropoiesis-stimulating drug
Chemotherapy
- At least 3 weeks since prior estramustine
Endocrine therapy
- See Disease Characteristics
- At least 3 weeks since prior antiandrogen treatment
Concurrent chemical castration with LHRH allowed provided patient has begun treatment prior to study entry
- No initiation of chemical castration therapy during study treatment
Radiotherapy
- No prior radiotherapy to > 25% of bone marrow
- No prior radioisotope therapy
- Concurrent local palliative radiotherapy for pain allowed
Surgery
- See Disease Characteristics
- At least 4 weeks since prior surgery
Other
- No other prior cytostatic treatment
Concurrent bisphosphonates allowed provided patient has begun treatment prior to study entry
- No initiation of bisphosphonates during study treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Arm I
Patients receive docetaxel IV over 1 hour on days 1 and 15 and oral prednisone once daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Given in 3- or 4- week courses
Given in 3- or 4- week courses
|
실험적: Arm II
Patients receive docetaxel IV over 1 hour on day 1 and prednisone once daily on days 1-21.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Given in 3- or 4- week courses
Given in 3- or 4- week courses
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
---|
치료 실패까지의 시간(TTF)
|
2차 결과 측정
결과 측정 |
---|
응답률
|
전반적인 생존
|
안전
|
Quality of life every 6 weeks until TTF
|
Use of epoetin beta
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Pirkko Kellokumpu-Lehtinen, Tampere University Hospital
간행물 및 유용한 링크
일반 간행물
- Kellokumpu-Lehtinen PL, Harmenberg U, Joensuu T, McDermott R, Hervonen P, Ginman C, Luukkaa M, Nyandoto P, Hemminki A, Nilsson S, McCaffrey J, Asola R, Turpeenniemi-Hujanen T, Laestadius F, Tasmuth T, Sandberg K, Keane M, Lehtinen I, Luukkaala T, Joensuu H; PROSTY study group. 2-Weekly versus 3-weekly docetaxel to treat castration-resistant advanced prostate cancer: a randomised, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):117-24. doi: 10.1016/S1470-2045(12)70537-5. Epub 2013 Jan 4.
- Hervonen P, Joensuu H, Joensuu T, Ginman C, McDermott R, Harmenberg U, Nyandoto P, Luukkaala T, Hemminki A, Zaitsev I, Heikkinen M, Nilsson S, Luukkaa M, Lehtinen I, Kellokumpu-Lehtinen PL. Biweekly docetaxel is better tolerated than conventional three-weekly dosing for advanced hormone-refractory prostate cancer. Anticancer Res. 2012 Mar;32(3):953-6. Erratum In: Anticancer Res. 2012 Sep;32(9):4169. multiple author names corrected.
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AVENTIS-FIN-1-2003
- CDR0000442891 (레지스트리 식별자: PDQ (Physician Data Query))
- FINNISH-URO-OGS-1-2003
- PROSTY-FIN-1-2003
- ICORG-06-14-Prosty
- EU-20891
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. .
전립선암에 대한 임상 시험
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
-
University of UtahNational Cancer Institute (NCI)모병피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
-
Weill Medical College of Cornell UniversityMillennium Pharmaceuticals, Inc.완전한신경내분비성 전립선암 | 소세포 전립선암 | Prostate Adenocarcinoma Plus > 신경내분비 표지자에 대한 50% 면역조직화학적 염색미국
-
Jonsson Comprehensive Cancer Center아직 모집하지 않음전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Rashmi Verma, MDNational Cancer Institute (NCI)모병거세저항성 전립선암 | 전이성 전립선 선암종 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.종료됨2기 전립선암 AJCC v8 | IIIA기 전립선암 AJCC v8 | IIIB기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | 3기 전립선암 AJCC v8 | IIIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
-
Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
docetaxel에 대한 임상 시험
-
Hebei Medical University Fourth Hospital완전한