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

Prostate Cancer Clinical Trial

— multiIMPROD2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04287088
• Other study ID #: T326/2019
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: December 31, 2041

Study information

• Verified date: November 2021
• Source: Turku University Hospital
• Contact: Peter Boström, MD
• Phone: 023130000
• Email: peter.bostrom[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2041
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Finland	Central Finland Central Hospital	Jyväskylä
Finland	Satakunta Central Hospital	Pori
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (6)

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

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biopsy criteria outcome	The number of biopsies and the number of clinically significant prostate cancer detected for each biopsy criteria	baseline
Other	Calibration of the model	Calibration of the model using both Likert and PI-RADS2.1 criteria	Baseline
Other	Calibration of the model using biomarkers	Calibration of the model using biomarkers such as the four kallikrein panel	Baseline
Primary	Gleason 4+3=7 prostate cancer, baseline	The proportion of men with clinically significant prostate cancer (Gleason 4+3 [ISUP grade group, the GGG, 3]) prostate cancer or higher) in the control and intervention arms after primary diagnostic pathway	baseline
Secondary	Gleason 3+4=7 or lower prostate cancer, baseline	The proportion of men with clinically non-significant prostate cancer and intermediate risk prostate cancer (Gleason 3+3 [GGG 1], and Gleason 3+4 [GGG 2]) and benign biopsies in the control and intervention arms after primary diagnostic pathway	baseline
Secondary	Men undergoing biopsies	The proportion of men undergoing biopsies in the control and intervention arms	baseline
Secondary	Biopsy related complications	The proportion of men having biopsy-related complications in the control and intervention arms	baseline
Secondary	Gleason 4+3=7 prostate cancer, follow-up	The proportion of men with clinically significant prostate cancer (Gleason 4+3 [GGG 3], prostate cancer or higher) in the control and intervention arms during the five years of follow-up	during the five years of follow-up
Secondary	the Memorial Anxiety Scale for Prostate Cancer -questionnaire (MAX-PC)	Total score in MAX-PC in the control and intervention arms. Score range: 0-54. Higher scores in MAX-PC denote higher anxiety.	baseline, 6months, 12months
Secondary	Biopsy probability	The probability of performing biopsy in experimental arm	baseline

External Links

•   IMPROD trial
•   multi-IMPROD trial