Comparing pOrtable MRI and TRUS-Fusion Prostate Biopsy to Assess aCcuracy of Prostate Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Percentage of Clinicical Significance of Cancer Detected
研究概览
简要总结
Currently, patients suspected of having prostate cancer undergo an MRI followed by targeted biopsies of any suspicious lesions under trans-rectal ultrasound (TRUS) guidance. This pathway is labour, time, and cost-intensive. Additionally, TRUS-MRI-Fusion devices are needed, which overlay the MRI scan onto the TRUS used for biopsies. This can lead to targeting errors due to mismatched images. Although biopsies can be performed in the MRI scanner to reduce these errors, it requires a significant amount of time within an expensive MRI scanner in the radiology department, along with special MRI-compatible equipment. Portable MRI technology has the potential to reduce these errors and streamline the diagnostic pathway to one visit. The Promaxo portable MRI is an FDA-cleared MRI device for MR-guided procedures. It uses a novel "truly" open MRI with an unobstructed field of view and a central aperture for robotic-guided intervention and has a limited footprint, allowing it to be placed in a standard operating theatre or large clinic room. The strength of the magnet is also low enough that special precautions and equipment are not needed to take biopsies.
The intention is to conduct a study that answers the following research question: How does the accuracy of targeted biopsies of the prostate performed under the guidance of a portable MRI scanner compare to TRUS-MRI-fusion biopsies?
Design: A single-arm, single-center IDEAL stage 2a study (n=85 patients) of patients undergoing prostate biopsy for suspected prostate cancer, where each patient would undergo both a portable MRI-registered biopsy and a TRUS-image-fusion biopsy. To reduce the risk of bias between the two modalities, the order of the modality will be randomized 1:1. There will be no blinding of the surgeon.
The primary outcome will be the technical feasibility of performing portable MRI and portable MRI-targeted biopsies and estimates on cancer detection.
详细描述
Design: A single arm, singe centre study of 85 patients who have been selected to undergo prostate biopsy for suspected prostate cancer. Each patient would undergo both a portable MRI registered biopsy and the local standard ultrasound fusion biopsy. To reduce the risk of bias between the two types of biopsy the sequence will be randomised 1:1. There will be no blinding of the surgeon.
Patient Journey:
Patients eligible for the study will have already undergone a standard of care prostate MRI and offered a biopsy for any suspicious lesions seen. Eligible Patients will initially be contacted by a member of the study team and given written information on the study, After a period of time for the patient to review the information the patient will be contacted to give consent which can either be performed remotely or face-to-face.
After consent they will be asked to fill in questionnaires for baseline genito-urinary and bowel function using validated questionnaires and overall health status; this will be online or via paper copies. The questionnaires will consist of the HADS score questionnaire, EPIC (urinary, erectile, bowel) questionnaires and EuroQoL [EQ-5D-5L].
Patients who have consented to the study will then undergo a combined biopsy procedure either under local anaesthetic or if the patient wishes under sedation or general anaesthetic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or above (no upper limit)
- •Raised age specific PSA
- •LIKERT/PIRADS 3 or above lesion on prostate mpMRI who have been advised to undergo a prostate biopsy.
排除标准
- •Patients who are unable to undergo a diagnostic standard of care MRI due to metallic implants, foreign body or devices.
- •Patients with a Cardiac pacemaker or Implantable cardioverter-defibrillator (ICD).
- •Contraindication to performing a biopsy guided by a transrectal ultrasound probe
- •Unable to give informed consent to the study
结局指标
主要结局
Percentage of Clinicical Significance of Cancer Detected
时间窗: 2 years
The proportion of patients with biopsy cores that yield cancer-positive results and the concordance between MRI-guided biopsy results and histopathological findings.
Technical feasibility of performing portable MRI and portable MRI targeted biopsies.
时间窗: 2 years
Percentage of biopsy completed
次要结局
- Patient reported outcome measures (PROMS / EPIC) of genitourinary health(2 years)
- Patient reported outcome measures (PROMS / EuroQol) of genitourinary health(2 years)
- Patient reported outcome measures (PROMS / HADS-D) of genitourinary health(2 years)
- Overall health-related quality of life as assessed by IPSS-QoL(2 years)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(2 years)
- Overall health-related quality of life as assessed by IPSS(2 years)
- The sensitivity, specificity, and accuracy of using portable MRI to detect clinically significant prostate cancer(2 years)
- Concordance Rate of Prostate Cancer Detection between Portable MRI and Standard mpMRI(2 years)
- Overall health-related quality of life as assessed by ICIQ-UI short form(2 years)
- Overall health-related quality of life as assessed by EQ5D(2 years)