bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis

Официальное название

Prebiopsy Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer - A Multi-centre Trial on Clinical Utility of IMPROD bpMRI in a Shared Decision Making Setting

Обзор

The shortcoming of the pre-biopsy prostate MRI approach is the recommendation to biopsy all men post-MRI even if there is no lesion seen in MRI, ie. risk of PCa is very low. Therefore, the primary objective of this trial is to compare if there is a difference between significant cancer detection rate in men undergoing prostate biopsies after MRI scan compared to men undergoing post-MRI prostate biopsies only after a shared decision-making based on prostate cancer risk estimation. The trial will enrol 600 patients. The primary outcome measure is the the proportion of men with CSPCa (Gleason 4+3 prostate cancer or higher) between the control and intervention arms at baseline. Eligible men are randomised 1:1 in two groups. In control arm in all men prostate biopsies are performed after MRI whereas in intervention arm prostate biopsies are performed only after a shared decision-making between urologist and the patient and the discussion is based on risk estimation.

Подробное описание

Although most of the prostate cancers (PCas) are currently being diagnosed at early stage, at present, 30% of men are diagnosed with primarily metastatic disease. The need for better diagnostic methods is, therefore, warranted. Recent studies have shown that an alternative pathway using multiparametric (mpMRI) or biparametric (bpMRI) magnetic resonance imaging as a triage test reduces unnecessary biopsies, decreases the detection of clinically non-significant PCa (non-SPCa), and improves the detection of clinically significant PCa (CSPCa). In addition, based on these trials, also EAU guideline was updated to recommend that all men should undergo pre-biopsy mpMRI. However, shortcoming of the approach is the recommendation to biopsy all men post-MRI even if there is no lesion seen in MRI, ie. risk of PCa is very low. Therefore, the primary objective of this randomised controlled trial is to compare if there is a difference between significant cancer detection rate in men undergoing prostate biopsies after MRI scan compared to men undergoing post-MRI prostate biopsies only after a shared decision-making based on prostate cancer risk estimation.

The trial will enrol 600 patients from four hospital districts: Varsinais-Suomi, Satakunta, Pirkanmaa and Keski-Suomi. Key inclusion criteria are suspicion of prostate cancer based on elevated PSA and/or abnormal digital rectal examination. Men with previous PCa diagnosis and contraindications for MRI are excluded. The primary outcome measure is the comparison of the proportion of men with CSPCa (Gleason 4+3 prostate cancer or higher) between the control and intervention arms at baseline.

Using PSA as strata, eligible men are randomised 1:1 in two groups. After randomisation MRI examination is performed and interpreted by one experienced uro-radiologist using Likert and PI-RADS2.1 classifications. In control arm in all men prostate biopsies are performed after MRI whereas in intervention arm prostate biopsies are performed only after a shared decision-making between urologist and the patient and the discussion is based on risk estimation. Men with negative biopsies or with no biopsies performed are all assigned for five-year follow-up with semi-annual PSA. Long-term follow-up based on health records and national registries is performed for additional 15 years for all patients.

Вмешательства

• Диагностический тест A shared decision making
  Based on prostate cancer risk calculation (age, usage of 5-ARI medication, baseline PSA, IMPROD bpMRI Likert, prostate volume) a shared decision making whether to perform prostate biopsies or not

Первичные конечные точки

• Gleason 4+3=7 prostate cancer, baseline [Срок оценки: baseline]

Вторичные конечные точки (6)

• Gleason 3+4=7 or lower prostate cancer, baseline [Срок оценки: baseline]
• Men undergoing biopsies [Срок оценки: baseline]
• Biopsy related complications [Срок оценки: baseline]
• Gleason 4+3=7 prostate cancer, follow-up [Срок оценки: during the five years of follow-up]
• the Memorial Anxiety Scale for Prostate Cancer -questionnaire (MAX-PC) [Срок оценки: baseline, 6months, 12months]
• Biopsy probability [Срок оценки: baseline]

Критерии участия

Критерии включения

• Age: 18 years or older
• Language spoken: Finnish
• Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 20 ng/ml and/or abnormal digital rectal examination according to the referral physician
• Mental status: Patients must be able to understand the meaning of the study
• Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Критерии исключения

• previous diagnosis of prostate cancer
• any contraindications for MRI
• any other conditions that might compromise patient's safety, based on the clinical judgment of the responsible urologist
• bilateral hip prosthesis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Финляндия · 4 центра

• Central Finland Central Hospital — Jyväskylä
• Satakunta Central Hospital — Pori
• Tampere University Hospital — Tampere
• Turku University Hospital — Turku

Публикации

• Ettala O, Jambor I, Montoya Perez I, Seppanen M, Kaipia A, Seikkula H, Syvanen KT, Taimen P, Verho J, Steiner A, Saunavaara J, Saukko E, Loyttyniemi E, Sjoberg DD, Vickers A, Aronen H, Bostrom P. Individualised non-contrast MRI-based risk estimation and shared decision-making in men with a suspicion of prostate cancer: protocol for multicentre randomised controlled trial (multi-IMPROD V.2.0). BMJ PMID 35428621

Идентификаторы

NCT: NCT04287088 · T326/2019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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