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

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

Sponsors

Lead sponsor: Turku University Hospital

Collaborator: Tampere University Hospital
Satakunta Central Hospital
Central Finland Hospital District
Memorial Sloan Kettering Cancer Center
Mount Sinai Hospital, New York

Source Turku University Hospital
Brief Summary

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.

Detailed Description

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.

Overall Status Recruiting
Start Date February 17, 2020
Completion Date December 31, 2041
Primary Completion Date December 31, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Gleason 4+3=7 prostate cancer, baseline baseline
Secondary Outcome
Measure Time Frame
Gleason 3+4=7 or lower prostate cancer, baseline baseline
Gleason 4+3=7 prostate cancer, follow-up during the five years of follow-up
the Memorial Anxiety Scale for Prostate Cancer -questionnaire (MAX-PC) baseline, 6months, 12months
Enrollment 600
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: A shared decision making

Description: 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

Arm group label: Intervention

Eligibility

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Peter Boström, MD

Phone: 023130000

Phone ext: 358

Email: [email protected]

Location
facility status contact
Central Finland Central Hospital Not yet recruiting Heikki Seikkula, MD 142691811 358 [email protected]
Satakunta Central Hospital Recruiting Marjo Seppänen, MD 262771 358 [email protected]
Tampere University Hospital Not yet recruiting Antti Kaipia, MD 3311611 358 [email protected]
Turku University Hospital Recruiting Otto Ettala, MD 23130000 358 [email protected] Kari Syvänen, MD Sub-Investigator
Location Countries

Finland

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Control

Arm group type: No Intervention

Description: After IMPROD bpMRI all men undergo prostate biopsies. In men with Likert scores of 1-2, TRUS guided systematic biopsies are performed. In men with Likert 3-5 score, in addition to systematic biopsies, two targeted biopsies are taken from each lesion (up to two lesions).

Arm group label: Intervention

Arm group type: Experimental

Description: After IMPROD bpMRI prostate biopsies are performed according to shared decision-making by the treating urologist and the patient. If biopsies are to be performed, in men with IMPROD bpMRI likert scores of 1-2, 12-core systematic TRUS guided biopsies are performed and in men with Likert 3-5 score lesions systematic biopsies are performed and two targeted biopsies are taken from each lesion (up to two lesions). If biopsies are not performed, men are referred for a PSA follow-up.

Acronym multiIMPROD2
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov