Trial Title:
Prostate Cancer Screening With Abbreviated MRI Protocol
NCT ID:
NCT05603351
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
magnetic resonance imaging
biparametric MRI
prostate cancer
PI-RADS
PSA
preventive medicine
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
A prospective cross-sectional (with a longitudinal component, 2nd screening round) study
evaluating the possibility of using the abbreviated bpMRI protocol technique for
screening clinically significant prostate cancer in men from the general population.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
magnetic resonance
Description:
biparametric MRI with protocol including anatomical T2 sequence and diffusion-weighted
images (DWI), according to the standards
Arm group label:
Preventive prostate examination by bpMRI
Other name:
MRI
Intervention type:
Diagnostic Test
Intervention name:
serum PSA examination
Description:
testing of prostate-specific antigen (PSA) in serum
Arm group label:
Preventive prostate examination by bpMRI
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Men with a positive MR test are planned for a targeted MRI/US fusion and systematic
prostate biopsy.
Men with a positive blood marker (either PSA, PSAD, or PHI) are planned for a systematic
12 core biopsy. Positive test results are PSA ≥ 3, integrated marker PSAD ≥ 0.15, and PHI
≥ 35.
Arm group label:
Preventive prostate examination by bpMRI
Summary:
Prostate cancer is one of the most common malignancies in the male population with
incidence and mortality rates comparable to breast cancer in women, but in contrast, a
population screening program that would fulfill all the recommended criteria is not yet
available. According to international recommendations, the preventive PSA sampling used
in clinical practice is not suitable because of the concurrent detection of clinically
insignificant carcinomas in a major proportion of tests. These clinically non-significant
cancers make up a significant and increasing proportion with age. Detection of
non-significant cancers burdens the health care system and patients with the care that
has no positive impact on their health. Current preventive serum prostate-specific
antigen (PSA) testing does not distinguish benign hyperplasia and nonsignificant
carcinoma from clinically significant cancer. It is therefore not suitable for full-scale
screening.
According to current guidelines, magnetic resonance imaging (MRI) is indicated only in
patients with an increased risk of cancer for detection or staging after biopsy and is
not used for screening. According to recent studies, MRI has detected an increased
proportion of significant cancers in the general population compared to screening based
on PSA, while fewer clinically insignificant cancers have been detected. In screening, a
shorter examination protocol without contrast medium (biparametric MRI) is used with a
lower cost per examination, allowing to increase both the number of patients examined and
patient comfort.
The main objective of the project is to assess the contribution of imaging in the
screening of clinically significant prostate cancer and to validate the published results
in the Czech population, and extend the screening model by the second round of
examinations and additional laboratory markers. The secondary aim is to design a
subsequent study with a larger number of participants allowing statistical evaluation,
similar to the successful breast cancer screening.
Detailed description:
A prospective cross-sectional (with a longitudinal component, 2nd screening round) study
evaluating the possibility of using the biparametric MRI protocol technique for screening
clinically significant prostate cancer in men from the general population.
Tests performed:
- Serum PSA
- PHI calculation (Prostate Health Index) to be performed only if the PSA values are
in the range of 2-10 ng/l
- MRI of the prostate (abbreviated biparametric protocol)
- Digital rectal examination (DRE) as part of a clinical visit at a urologist in
patients with a positive PSA test
- Biopsy - if indicated
MRI specifications:
- Protocol with anatomical T2 sequence and diffusion-weighted images (DWI), according
to the standards
- Typical complete examination time does not exceed 20 minutes, planned acquisition
time less than 15 minutes.
- No contrast agent or spasmolytics is injected.
Blinding:
- Every test evaluator (radiologist/urologist) does not know the results of other
tests. · MRI reports entered in the registry obligatorily before the biopsy.
- The patient is not informed which test was positive and resulted in an indication
for biopsy.
- The pathologist does not know the results of MRI or laboratory tests.
The sequence of tests:
The MRI is assessed with the PI-RADS 2.1 system, each finding is reported on a scale of
1-5. To minimize the detection of non-significant cancers and to reduce the number of
biopsies according to the results of the IP1-Prostagram study, a PI-RADS value of 4-5 was
chosen as a positive test representation.
Consensual double reading by 2 experienced uroradiologists (at least 400 MRI of the
prostate read by the beginning of the study). Men with a positive MRI test are planned
for a targeted MRI/US fusion and systematic prostate biopsy.
Men with a positive blood marker (either PSA, PSAD, or PHI) are planned for a systematic
12 core biopsy. Positive test results are PSA ≥ 3, integrated marker PSAD ≥ 0.15, and PHI
≥ 35.
Study participants are invited to repeat the screening tests after 2 years by letter. If
they do not respond to a written offer, also by e-mail and SMS.
Definition of clinically significant cancer: • ISUP Grade Group ≥ 2.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 50-69 years
- Life expectancy over 10 years
- Ability to undergo all planned procedures (without contraindications to MRI or
biopsy)
- No known prostate cancer or prostate biopsy in the past (interventions for BPH are
not a restriction)
- No PSA test or prostate MRI in the past 2 years.
- No signs of prostatitis or urinary tract infection in the past 6 months.
- Signed informed consent.
Exclusion Criteria:
- Contraindications to MRI
- Hip replacement
- Known BRCA1/BRCA2 mutation
Gender:
Male
Gender based:
Yes
Gender description:
Due to the nature of examined organ (prostate), this study is focused exclusively on men.
Minimum age:
50 Years
Maximum age:
69 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Masaryk Memorial Cancer Institute
Address:
City:
Brno
Zip:
65653
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Michal Standara, MD
Phone:
+420543136008
Email:
standara@mou.cz
Contact backup:
Last name:
Jan Kristek, Ph.D., MD
Phone:
+420605444732
Email:
jan.kristek@mou.cz
Investigator:
Last name:
Michal Stanik, Ass.Prof.
Email:
Principal Investigator
Investigator:
Last name:
Michal Standara, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jan Kristek, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Alexandr Poprach, Ass.Prof.
Email:
Sub-Investigator
Investigator:
Last name:
Milos Pacal, MD
Email:
Sub-Investigator
Investigator:
Last name:
Iva Babankova, MD
Email:
Sub-Investigator
Investigator:
Last name:
David Miklanek, MD
Email:
Sub-Investigator
Start date:
May 1, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Masaryk Memorial Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Masaryk University
Agency class:
Other
Source:
Masaryk Memorial Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05603351
https://www.uroweb.cz/index.php?pg=odborne-analyzy-a-publikace--epidemiologie-nadoru-urogenitalniho-systemu-v-ceske-republice
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