• Determine the impact of variations in multi-parametric MRI on the prediction of tumor probability
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The robustness of multiparametric imaging for planning of dose painting
radiotherapy of prostate cancer is investigated. The variation in the
prediction of tumor probability is determined in a test-retest setting.
Secondary outcome
• Determine the reproducibility of multi-parametric quantitative MRI
• Determine whether there are differences in reproducibility of
multi-parametric quantitative MRI between centers
• Determine the impact of variations in predicted tumor probability on the
planned treatment dose
• Validate the predicted tumor probability with whole-mount section histology
of prostatectomy specimen
Background summary
Dose painting is a radiotherapy (RT) technique in which the radiation dose is
varied locally according the probability of tumor presence and resistance to
treatment. This can be assessed using multiparametric MRI.
In this study, the robustness of multi-parametric MRI for dose painting of
prostate cancer is investigated. To this end, the steps that lead from imaging
to the creation of a dose painting treatment plan are evaluated.
Study objective
• Determine the impact of variations in multi-parametric MRI on the prediction
of tumor probability
Study design
Registration study
Intervention
diagnostic MRI exam will be repeated
Study burden and risks
Patients will undergo the standard MRI exam a second time (combined with
another hospital visit if possible). In a standard exam, an endorectal receive
coil may be used to obtain optimal signal to noise. This causes mild discomfort
for the patient. In the standard exam 15 ml of the contrast agent Dotarem
(Gadoteric acid, concentration 0.5M) is administered intravenously. No adverse
effects are known of the administration of a second dose one week after the
regular exam. But an allergic reaction cannot be ruled out. For patient who
underwent the first MRI exam as part of the treatment the repeat of the MRI
exam causes a negligible risk for the patient but an allergic reaction is well
to treat.
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Listed location countries
Age
Inclusion criteria
Patients with biopsy-proven prostate cancer who are scheduled for a prostatectomy
Exclusion criteria
• Contra-indications for a MRI exam according to the standard protocol for the screening of patients with prostate cancer
• Treatment of prostate cancer prior to the MRI exams
• Prior hormonal therapy
• Prior trans-urethral resection (TURP)
• GFR < 30 ml/min/1,73 m²
Design
Recruitment
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 |
|---|---|
| CCMO | NL46247.031.13 |