The primary objective is to collect high-quality 3D mpUS and histology data, to train and improve the classifier algorithm with the goal of achieving an accurate ultrasound imaging tool for the detection of clinically significant prostate cancer.…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the primary objective, training and improving the algorithm, we focus on
• Gleason/Grade group scoring based on histology. Using histology as the
reference standard we will optimize the accuracy of the algorithm in
differentiating between benign tissue and various grades of malignancy.
• Localization and size of lesions at full-gland histology in the subset of
patients undergoing radical prostatectomy. Correlation in tumour size and
location will be optimized between 3D mpUS findings and histology of the full
gland.
Secondary outcome
For the secondary objective, preliminary assessment of the performance of 3D
mpUS, we will evaluate the following endpoints:
• Among all clinically significant detected cancers confirmed by histology, we
will calculate the proportion of these cancers that would have been detected by
3D mpUS. This sensitivity of 3D mpUS will be calculated within the following
subgroups given the differences in quality of the applied reference standard:
patients undergoing radical prostatectomy; patients undergoing both targeted
and systematic biopsies; patients undergoing only systematic biopsies. The
number of false positive findings by 3D mpUS both as an absolute count and
expressed as a mean rate per patient. This will be done again stratified for
the 3 subgroups mentioned above
• The concordance in the detection and grading of abnormalities between mpMRI
and 3D mpUS by examining the frequency and type of disagreements and
calculating the kappa statistic.
Background summary
Current imaging techniques for the detection and grading of prostate cancer are
imperfect, leading to unnecessary biopsies, suboptimal treatment decisions and
missed clinically significant cancers. We hypothesize that computer assisted
analysis of 3D multiparametric ultrasound (mpUS) images can accurately detect,
grade and localize prostate cancer. 3D mpUS may then become a more
cost-effective and more streamlined imaging strategy than the current standard:
mpMRI.
Study objective
The primary objective is to collect high-quality 3D mpUS and histology data, to
train and improve the classifier algorithm with the goal of achieving an
accurate ultrasound imaging tool for the detection of clinically significant
prostate cancer.
Secondary objectives are related to the preliminary assessment of the
performance of 3D mpUS with computer assisted analysis.
Study design
This is a prospective, multi-center study in men with a suspicion of prostate
cancer who are scheduled for prostate biopsies, and men with confirmed prostate
cancer who are scheduled to undergo a radical prostatectomy. Prior to prostate
biopsies or the radical prostatectomy, 3D mpUS imaging will be performed. The
ultrasound images will be analyzed and used for algorithm training using the
biopsies and/or prostatecomy specimens as gold standard. Additional research
coupes of pathology material (both biopsies and radical prostatectomy
specimens) from study participants will be anonymized and separately analyzed
and stored in a central, independent institution. The outcome of the 3D mpUS
analysis and the additional pathology evaluation are for research purposes only
and will not interfere with standard patient care.
Study burden and risks
To obtain 3D mpUS images, patients will undergo standard transrectal ultrasound
after the administration of ultrasound contrast intravenously. Transrectal
ultrasound is part of the standard prostate biopsy procedure. To obtain 3D mpUS
images from patients scheduled for radical prostatectomy an additional visit to
the including center is necessary. The additional visit and transrectal
ultrasound can be experienced as a significant burden for the patient. Study
participants will be informed on this additional burden.
The administration of ultrasound contrast is and will lead to an additional
five minutes of examination time. There is a small anticipated risk associated
with the use of ultrasound contrast for participants. After use in millions of
patients in various types of ultrasound examinations, adverse events to the
ultrasound contrast agent appear to be transient, mild and rare. The side
effects of the ultrasound contrast agent mostly consist of transient alteration
of taste, local pain at the injection site and facial or general flush. In some
cases, an allergic reaction is described that is usually mild. Patients will be
informed of the risk during intake, and it will be described in the patient
information file. The 3D mpUS images will not be used for making management
decisions, consequently there will be no safety issues due to changes in
standard care, but also no direct benefit for patients participating in the
study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Men >=18 years with a clinical suspicion of prostate cancer or confirmed
prostate cancer.
Scheduled for either systematic and/or targeted biopsy after mpMRI examination
or radical prostatectomy
Exclusion criteria
- No mpMRI performed prior to prostate biopsy or radical prostatectomy
- A history of chemotherapy for PCa or currently being treated with
chemotherapy for PCa.
- A patient history that includes any of the following prostate related
interventions:
o Brachytherapy or external radiotherapy for PCa;
o Focal therapy for prostate cancer;
o Prostate biopsy within the last 30 days.
- Hormonal therapy for prostate cancer within the last six months
- A patient history with a cardiac right to left shunt.
- Current treatment with dobutamine
- Known severe pulmonary hypertension (pulmonary artery pressure >90 mmHg),
uncontrolled systemic hypertension or respiratory distress syndrome
- Incapable of understanding the language in which the patient information is
given.
- Allergic reaction to previous ultrasound contrast administration.
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04605276 |
| CCMO | NL75616.018.20 |