MRI in Diagnosing Prostate Cancer
PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find prostate cancer and learn the extent of disease.
PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in diagnosing prostate cancer.
연구 개요
상태
정황
상세 설명
OBJECTIVES:
- To determine the ability of multiparametric magnetic resonance imaging (MP-MRI) to identify men who can safely avoid unnecessary biopsy.
- To assess the ability of the MP-MRI-based diagnostic pathway to improve the rate of detection of clinically significant cancer as compared to transrectal ultrasound (TRUS) biopsy.
- To estimate the cost-effectiveness of an MP-MRI based diagnostic pathway.
OUTLINE: This is a multicenter study.
Patients undergo multiparametric magnetic resonance imaging (MRI) (T2-weighted imaging, diffusion-weighted MRI, and dynamic contrast-enhanced MRI) followed by template prostate mapping and transrectal ultrasound biopsy.
Some patients may undergo blood, urine, and tissue sample collection periodically for biomarker studies. Samples are banked for future research analysis.
Patients complete a quality-of-life questionnaire (EQ-5D) at baseline, during, and after completion of study. An economic analysis will be performed for cost-effectiveness.
After completion of study intervention, patients are followed up periodically.
연구 유형
등록 (예상)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Men at risk of prostate cancer who have been advised to have a prostate biopsy
- Suspected stage ≤ T2 on rectal examination (organ confined)
- Serum PSA ≤ 15 ng/mL within the past 3 months
PATIENT CHARACTERISTICS:
- Fit for general/spinal anesthesia
- Fit to undergo all protocol procedures including a transrectal ultrasound
- No evidence of a urinary tract infection or history of acute prostatitis within the past 3 months
- No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50)
- No other medical condition precluding procedures described in the protocol
PRIOR CONCURRENT THERAPY:
- No prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable)
- No prior hip replacement surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Safety of multiparametric magnetic resonance imaging (MP-MRI)
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Recruitment
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Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values
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Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values
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2차 결과 측정
결과 측정 |
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Proportion of men who could safely avoid biopsy
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Proportion of men testing positive on MP-MRI
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Performance characteristics of TRUS versus template prostate mapping (TPM)
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Evaluation of the optimal combination of MP-MRI functional parameters
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Intra-observer variability in the reporting of MP-MRI
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Evaluation of socio-demographic, clinical, imaging and radiological variables in relation to the detection of clinically significant prostate cancer
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Health-related quality of life using the EQ-5D questionnaire
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Resource use and costs for further economic evaluation
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Translational research
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mark Emberton, MD, FRCS, MBBS, University College London Hospitals
간행물 및 유용한 링크
일반 간행물
- Brown LC, Ahmed HU, Faria R, El-Shater Bosaily A, Gabe R, Kaplan RS, Parmar M, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham A, Oldroyd R, Parker C, Bott S, Burns-Cox N, Dudderidge T, Ghei M, Henderson A, Persad R, Rosario DJ, Shergill I, Winkler M, Soares M, Spackman E, Sculpher M, Emberton M. Multiparametric MRI to improve detection of prostate cancer compared with transrectal ultrasound-guided prostate biopsy alone: the PROMIS study. Health Technol Assess. 2018 Jul;22(39):1-176. doi: 10.3310/hta22390.
- Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료
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
기타 연구 ID 번호
- MRC-PR11
- CDR0000694647 (레지스트리 식별자: PDQ (Physician Data Query))
- EU-21104
- UCL-11/009
- ISRCTN16082556 (레지스트리 식별자: ISRCTN (International Standard Randomised Controlled Trial Number Register))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
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