Primary objective: • Investigate the signature of recurrent prostate cancer and of radiation effects after external-beam radiotherapy on multi-parametric MRISecondary objective: • Identify imaging features that are characteristic of recurrent…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Investigate the signature of recurrent prostate cancer and of radiation effects
after external-beam radiotherapy on multi-parametric MRI
Secondary outcome
NA
Background summary
External beam radiation therapy (EBRT) is a commonly used treatment modality in
localized prostate cancer. However in 27-53% of cases a biochemical relapse
occurs and at present these patients are generally managed with palliative
treatment options such as androgen deprivation therapy (ADT). In the absence of
disseminated disease, focal salvage therapy can be a viable option since it
results in decreased toxicity by delivering a localised treatment to the
tumour. Hence there is a need for detailed information about tumour location.
Multi-parametric MRI (mp-MRI) is already part of the standard screening for
primary tumours.
At the time of recurrence the interpretation of images is challenging because
prostate tissue is changed by the primary radiotherapy. Fibrosis, inflammation
and glandular atrophy are some of the benign confounders present in the
irradiated prostate. By using mp-MRI to study patients after radiotherapy both
with and without a recurrence we will be able to characterise changes due to
irradiation and recurrent disease separately. Biopsies will be used as the
gold-standard for local recurrent tumour validation
Study objective
Primary objective:
• Investigate the signature of recurrent prostate cancer and of radiation
effects after external-beam radiotherapy on multi-parametric MRI
Secondary objective:
• Identify imaging features that are characteristic of recurrent prostate cancer
• Identify imaging features that are characteristic of radiation effects after
external-beam radiotherapy
• Determine sensitivity and specificity of mp-MRI in detecting recurrent
prostate cancer
• Assess the influence of available clinical information on the reading of the
images
Study design
Cross-sectional study, with matched cohorts
Intervention
multi-parametric MRI
Study burden and risks
Patients and controls undergo the multi-paramatric-MRI examination one time. In
the standard exam, 15 ml contrast DOTAREM (Gadoteric acid 0.5m) is
administrated i.v.. No side effects are known of this agent. However, an
allergic reaction can not be excluded but managable to treat.
Plesmanlaan 121
AMSTERDAM 1066 CX
NL
Plesmanlaan 121
AMSTERDAM 1066 CX
NL
Listed location countries
Age
Inclusion criteria
case group:- Biochemical failure, more than 24 months after completion of prior EBRT for treatment of prostate cancer;control group:
- Completion of prior EBRT for treatment of prostate cancer more than 24 months ago without biochemical failure
Exclusion criteria
- Hormonal treatment in the past year
- Patients who use anticoagulants and can not stop this temporarily for taking biopsies
- Contra-indications for an MRI exam according to the standard protocol for the screening of patients with prostate cancer
- Other treatments for cancer in the pelvis
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 | NL52307.031.15 |