- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07717268
Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients. (OLIGORESIST)
Radioterapia estereotáctica Fraccionada más antiandrógeno de Segunda generación Para Pacientes oligometastásicos Con cáncer de próstata Resistente a la castración. Estudio español Fase II, Prospectivo, multicéntrico.
The objectives of the study are to analyze the results obtained in survival, safety and quality of life after the combination of SBRT plus second-generation antiandrogen in patients diagnosed with metastatic castration-resistant prostate cancer in oligometastasis (≤5).
Hence, the investigators evaluate the results of the combination of two widely used treatments in prostate cancer: SBRT plus the 'standard of care' for patients with mCRPC, second-generation antiandrogens (abiraterone and enzalutamide).
Primary objective: Determine the PRFS measured from the time of initiation of second-generation antiandrogen to the time of radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
Secondary objectives:
- Overall survival (time from initiation of second-generation antiandrogen to exitus) in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
- Quality of life of these patients using the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale, EORTC QLQ-C30, validated for oncology patients.
- Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0) scale.
This is a phase II, multicenter, prospective, single group study in patients with castrate-resistant prostate cancer (CRPC).
Patients will be recruited at the participant sites, after study approval and hospital authorization.
51 patients will be included in the study. Eligible patients will require:
- Choline PET/CT or 68Ga-PSMA PET/CT, dated no more than 8 weeks prior to inclusion.
- Clinical history, physical examination and functional evaluation scale (ECOG).
- Geriatric assessment scale for patients > 75 years (modified G8 scale)
- Toxicity scale assessment (CTCAEv5.0)
- Baseline quality of life questionnaire (EORTC QLQ-C30) (47)
- Blood tests with complete blood count, coagulation, liver function, renal function, ions, alkaline phosphatase, PSA and total and free testosterone, dated no more than 4 weeks prior inclusion.
- Inclusion/exclusion criteria assessment
- Second generation antiandrogen prescription, chosen by the responsible physician according to clinical practice, in each case.
Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus). SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus.
Recruitment time is estimated at 36 months and a total follow-up time of 36 months. The total duration of the trial is therefore expected to be 6 years, to allow complete follow-up of the last patients included.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Pablo Raña Diez, PhD
- 전화번호: +34 696633409
- 이메일: investigacion@seor.es
연구 연락처 백업
- 이름: Cristina Gutierrez Povedano, PhD
- 전화번호: +34 675039150
- 이메일: cristina.gutierrez.povedano@navarra.es
연구 장소
-
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Aragon
-
Zaragoza, Aragon, 스페인, 50009
- 모집하지 않고 적극적으로
- Hospital Universitario Miguel Servet
-
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Barcelona
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Barcelona, Barcelona, 스페인, 08036
- 모병
- Hospital Clinic de Barcelona
-
연락하다:
- Joel Mases, MD
- 이메일: mases@clinic.cat
-
수석 연구원:
- Joel Mases i Rosinés, MD
-
부수사관:
- Elías Gomís, MD
-
부수사관:
- Sara Moreno, MD
-
부수사관:
- Gerard Meca, MD
-
L'Hospitalet de Llobregat, Barcelona, 스페인, 08908
- 모병
- Instituto Catalán de Oncología Hospitalet
-
연락하다:
- Anna Maria Boladeras, MD
- 이메일: aboladeras@iconcologia.net
-
수석 연구원:
- Ana María Boladeras Inglada, MD
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Basque Country
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Bilbao, Basque Country, 스페인, 48013
- 모집하지 않고 적극적으로
- Hospital Universitario Basurto
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Castille and León
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Salamanca, Castille and León, 스페인, 37007
- 모집하지 않고 적극적으로
- Hospital Universitario De Salamanca
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Valladolid, Castille and León, 스페인, 47003
- 모병
- Hospital Clínico Universitario de Valladolid
-
연락하다:
- Patricia Diezhandino Garcia, MD
- 전화번호: +34 983 420 003
- 이메일: pdiezhandino@saludcastillayleon.es
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수석 연구원:
- Patricia Diezhandino Garcia, MD
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Catalonia
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Barcelona, Catalonia, 스페인, 08041
- 모병
- Hospital de La Santa Creu i Sant Pau
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연락하다:
- Gemma Sancho Pardo, MD
- 전화번호: +34 935537756
- 이메일: gsancho@santpau.cat
-
연락하다:
- Saudy Peláez Bonilla, Study coordinator
- 전화번호: 776 +34 935537760
- 이메일: SPelaez@santpau.cat
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부수사관:
- Arantxa Mera Errasti, MD
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수석 연구원:
- Gemma Sancho Pardo, MD
-
부수사관:
- Laura Montezuma Niño, MD
-
부수사관:
- Ana Maria Soto Cambres, MD
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Terrassa, Catalonia, 스페인, 08227
- 모집하지 않고 적극적으로
- Consorci Sanitari de Terrassa
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-
Galicia
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Santiago de Compostela, Galicia, 스페인, 15706
- 모집하지 않고 적극적으로
- Complexo Hospitalario Universitario De Santiago
-
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Madrid
-
Madrid, Madrid, 스페인, 28040
- 모병
- Hospital Clinico San Carlos
-
연락하다:
- Noelia Sanmamed, MD
- 전화번호: +34 985 10 80 00
- 이메일: noelia.sanmamed@salud.madrid.org
-
수석 연구원:
- Noelia Sanmamed Salgado, MD
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부수사관:
- Manuel Gonzalo Vázquez Masedo, MD
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부수사관:
- Miren Gaztañaga Boronat, MD
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부수사관:
- Maria Nieves Cabrera Martin, MD
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부수사관:
- Natalia Vidal Cassinello, MD
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부수사관:
- Anxela Doval Gonzalez, MD
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부수사관:
- Javier Puente Vazquez, MD
-
부수사관:
- Ignacio Moreno, MD
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Madrid, Madrid, 스페인, 28034
- 모집하지 않고 적극적으로
- Hospital Ramon y Cajal
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Navarre
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Pamplona, Navarre, 스페인, 31008
- 모병
- Hospital Universitario de Navarra (HUN)
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수석 연구원:
- Marta Barrado Los Arcos, MD
-
연락하다:
- Marta Barrado Los Arcos, MD
- 전화번호: +34 848 42 84 82
- 이메일: marta.barrado.losarcos@navarra.es
-
부수사관:
- Amaya Sola Galarza, MD
-
부수사관:
- Elena Villafranca Iturre, MD
-
부수사관:
- Ignacio Visus Fernandez de Manzanos, MD
-
부수사관:
- Nuria Bultó Boque, MD
-
부수사관:
- Xabier Gurutzeaga Peleato, MD
-
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Principality of Asturias
-
Oviedo, Principality of Asturias, 스페인, 33011
- 모집하지 않고 적극적으로
- Hospital Universitario Central de Asturias
-
-
Valencia
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Valencia, Valencia, 스페인, 46026
- 모집하지 않고 적극적으로
- Hospital Universitario y Politécnico de La Fe
-
-
Vizcaya
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Barakaldo, Vizcaya, 스페인, 48903
- 모집하지 않고 적극적으로
- Hospital De Cruces
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients with histologically prostate adenocarcinoma, confirmed with a biopsy.
- Testosterone in biochemical castration ranges (testosterone <50 ng/ml or 1.7 nmol/L) and documented progression: biochemical according to Phoenix criteria or distant by radiological confirmation (PSMA PET/CT or Choline PET/CT)
- Biochemistry progression confirmed according to Phoenix criteria, with testosterone in castration levels (testosterone <50 ng/ml or 1.7 nmol/L).
- Radiological confirmation (with choline-PET/CT or 68Ga-PSMA-PET/CT) of ≤5 node or bone metastasis, non-visceral, eligible to receive SBRT treatment (< 3 cm major diameter in bone metastases, < 5 cm in lymph node metastases). In the case of very close metastases, a limit of up to 5 treatment fields with SBRT is allowed, instead of 5 metastases.
- Patients candidate to receive treatment with abiraterone or enzalutamide as per clinical routine, and treatment selection and prescription assigned by responsible physician before the inclusion in the study. or or who has started treatment no more than 14 days prior to signing, as first-line treatment after a diagnosis of oligoresistance.
- Patients must provide written informed consent.
- Life expectancy > 3 months.
Exclusion Criteria:
- Patients with prostate carcinoma with histology other than adenocarcinoma.
- No previous biopsy.
- > 5 metastasis, not approachables in 5 treatment fields
- Patients with visceral metastasis and or metastasis non elegible to receive SBRT.
- Patients with Testosterone above castration levels
- Patients with prior treatment with docetaxel as first-line CRPC treatment (previous docetaxel treatment is permitted when administered as hormone-sensitive metastatic 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 |
|---|---|
|
다른: Second generation antiandrogen plus SBRT
Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus).
SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus
|
Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus)
Each patient will be included in the study once the second generation antiandrogen is initiated (which will be maintained until radiological progression, suspension due to poor tolerance and/or exitus)
다른 이름들:
SBRT will be performed at least 2 weeks after initiating treatment with second generation antiandrogen, without exceeding 8 weeks from the start of treatment, and follow-up will continue up to a maximum of 36 months after completion of SBRT and/or exitus
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Determine the PRFS
기간: From the start of the study (the day it begins) or up to 14 days before the start of the study (corresponding to the start of treatment with second-generation antiandrogens) until the time of radiological progression during follow-up, it can be up to 36.
|
Determine the PRFS measured from the time of initiation of second-generation antiandrogen to the time of radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen
|
From the start of the study (the day it begins) or up to 14 days before the start of the study (corresponding to the start of treatment with second-generation antiandrogens) until the time of radiological progression during follow-up, it can be up to 36.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall survival
기간: From the start of second-generation antiandrogen therapy (at baseline or up to 14 days prior) to the date of death from any cause, assessed up to 36 months.
|
Overall survival (time from initiation of second-generation antiandrogen to exitus) in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.
|
From the start of second-generation antiandrogen therapy (at baseline or up to 14 days prior) to the date of death from any cause, assessed up to 36 months.
|
|
Quality of life by EORTC scale
기간: from recruitment to the end of patient follow-up (up to 36 months)
|
QoL using the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale, EORTC QLQ-C30, validated for oncology patients. The scale converts all scores to a standardized range from 0 (minimum) to 100 (maximum). A high score indicates a better outcome (high quality of life and good health). |
from recruitment to the end of patient follow-up (up to 36 months)
|
|
Acute and chronic toxicity
기간: from recruitment to the end of patient follow-up (up to 36 months)
|
Acute and chronic toxicity according to the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0)
scale
|
from recruitment to the end of patient follow-up (up to 36 months)
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Marta Barrado Los Arcos, MD, Hospital of Navarra
간행물 및 유용한 링크
일반 간행물
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연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRA-RAD-2022-001
- 2023-505024-62 (EudraCT 번호)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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