The primary objective is to determine if the incorporation of Multimodality MRI including MRGB within the Prostate cancer Research International for Active Surveillance (PRIAS) study for low-risk low volume prostate cancer leads to a higher number…
ID
Source
Brief title
Condition
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the number of patients with a positive difference
in Gleason grade (upgrading) of follow-up MRGB versus inclusion TRUSGB
(expected to be 22% or higher in first year of follow-up and hopefully lower at
the end of the first year and in the fourth year of follow-up) versus the
number of patients with a positive difference in Gleason grade (upgrading) of
repeat TRUS-GB versus inclusion TRUS-GB (expected round 12% in first year of
follow-up and hopefully lower at the end of the first year and in the fourth of
follow-up). This maij study parameter will be determined at baseline ( 2
months), and at 1 and four years of follow-up.
Secondary outcome
Secondary study parameters include:
The number of cancers included in the PRIAS study that are visible on MRI.
The number of delayed interventions based on patient request after
incorporation of MRI.
Other study parameters are the mean progression free survival, the disease
specific mortality and overall mortality, the incidence of (lymfogenic)
metastasis in monitored population, the correlation of PCA3 values with
progression of low-grade prostate cancer
Background summary
Active surveillance with delayed intervention, as applied in the PRIAS study,
is now an accepted management option for patients with low-risk prostate
carcinoma, however delayed intervention rates are high (~25%), possibly due to
suboptimal patient selection caused by undersampling in TRUS guided biopsies.
Targeted MR guided biopsies (MRGB) provide more accurate histological tumor
characteristics, due to less undersampling of Gleason score, than conventional
systematic TRUS-biopsies, and may consequently lead to better patient selection
for active surveillance protocols and lower delayed intervention rates.
Multimodality MRI provides additional information on cancer localization and
stage and can give estimations on cancer stage, localization, volume and
characterization delivering more accurate follow-up information than PSA
kinetics, repeat DRE and repeat systematic TRUS-biopsy. Consequently
incorporation of Multimodality MRI in PRIAS will lead to earlier detection of
patients with progressive disease. Hypothesis: Incorporation of multimodality
MRI will improve patient selection and follow-up in active surveillance within
the PRIAS study, thus increasing patient safety. Through save active
surveillance many patients do not have to undergo unnecessary treatment with
negative complications as incontinence and impotence.
Study objective
The primary objective is to determine if the incorporation of Multimodality MRI
including MRGB within the Prostate cancer Research International for Active
Surveillance (PRIAS) study for low-risk low volume prostate cancer leads to a
higher number of cancers that is upgraded by follow-up (2 months, 1 and 4
years) MRGB versus initial baseline TRUSGB in comparison to upgrading of
cancers by follow-up ( 1 and 4 years) TRUSGB versus initial baseline TRUSGB .
We expect this difference in upgrading to be higher directly after the moment
of diagnosis and for it to be lower during follow-up.
Secondary Objectives:
The number of cancers included in the PRIAS study that are visible on MRI.
To determine if incorporation of MRI in PRIAS will lead to less delayed
intervention based on patient request.
To determine incidence of (lymphogenic) metastasis in monitored population.
To determine disease specific mortality, overall mortality and mean progression
free survival.
To determine the correlation of PCA3 values with progression of low-grade
prostate cancer.
Study design
A prospective cohort study.
Study burden and risks
Potential risks are risks of biopsy (blood loss, infection), risk and
discomfort of MRI (nervous stimulation, cutaneous sensations and heating of the
patient).
Geert Grooteplein 10
6525 GA Nijmegen
NL
Geert Grooteplein 10
6525 GA Nijmegen
NL
Listed location countries
Age
Inclusion criteria
• Histologically proven adenocarcinoma of the prostate
• PSA <= 10 ng/ml and PSA density <0.2 ng/ml/ml
• TRUS-biopsy Gleason Score <= 6 (no 4 or 5 pattern), TRUS-biopsy
characteristics: < 2 cores involved
• Clinical stage T1C or T2
• Appropriate biopsy sampling conform PRIAS study
Exclusion criteria
• Patients with known contradictions to MRI
• Patients with known contra-indications to Gadolinium based contrast agents.
• Patients with previous therapy for prostate cancer.
• Patients who can not or do not want to receive curative treatment in form of radiotherapy or radical prostatectomy
• Patient request for definitive curative intervention
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL27911.091.09 |
| OMON | NL-OMON23734 |