To measure the differences of DCE MR images between patients with and without local recurrent prostate cancer in the follow up after primary treatment.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is the difference between patients with and
without local recurrent prostate cancer, in terms of DCE parameters.
Secondary outcome
A secondary objective is to describe differences in DCE MRI parameters at
various time points in the follow-up.
Background summary
There is a need for new methods for the early detection of recurrent prostate
cancer after primary radiotherapy. Results from prostate biopsy are unreliable
and prostatectomy is undesirable. Literature concerning the reliability and the
interpretation of DCE MRI after radiotherapy is scarce and some significant
difficulties exist. As a result, at this moment objective interpretation of the
DCE data on itself is not possible.
Study objective
To measure the differences of DCE MR images between patients with and without
local recurrent prostate cancer in the follow up after primary treatment.
Study design
Case-control study (observational, pilot).
Study burden and risks
No extra risk is associated with the MRI exam, which is performed in all
patients. All patients have to pay one extra visit for the MRI examination.
Patients with biochemical failure will undergo prostate biopsy following the
European Association of Urology (EAU) guidelines. The risk of this biopsy is
minimal, and mainly includes infection and bleeding. Generally, individual
patients will not benefit from the extra MRI examination.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- Prostate cancer and therefore treated with external beam radiotherapy or I-125 implantation in the last 10 years, with a minimum follow-up of 2 years.
- Written informed consent.
Specific inclusion criteria for the case group:
- Biochemical failure as defined by the Phoenix criteria (nadir PSA level + 2 ng/mL)
- Positive prostate biopsy results
Exclusion criteria
Contra-indications for 3T MR imaging following the protocol of the department of Radiology UMCU.
Hormonal treatment < 1 year before inclusion in this study.
Advanced kidney disease.;Specific exclusion for the case group:
Contra-indication for prostate biopsy (for example oral anticoagulants use).
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 | NL25435.041.08 |