The first objective of this study is to test the hypothesis that a higher dose to the IPAs and corpora cavernosa is correlated to ED after EBRT. The second objective is to test the hypothesis that RIF in the IPAs and corpora cavernosa is correlated…
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
- Sexual function and fertility disorders
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is to analyze the correlation between the
radiation dose in the IPAs and ED after EBRT, based on IIEF scores.
Secondary outcome
The secondary endpoints are to test the hypothesis that RIF in the IPAs and
corpora cavernosa causes ED after EBRT.
Background summary
Erectile dysfunction (ED) is a side effect after external beam radiotherapy
(EBRT) for prostate cancer, affecting 50% to 60% of pre-treatment potent
patients. Radiation dose to the corpora cavernosa has the potential to be an
important factor in ED after EBRT. Several studies have tried to elucidate the
etiology of ED after radiotherapy by using Doppler ultrasound. These studies
demonstrated a reduced flow in the cavernosal arteries and venous leakage of
the corpora cavernosa in men with ED after EBRT. It is very well possible that
the decrease of flow in cavernous arteries is caused by an occlusion higher up,
in the IPAs. Untill now, there is no report analyzing dose-volume effects
between radiation dose in the IPAs and ED after radiotherapy. Our hypothesis is
that the inflow of blood into the corpora cavernosa is reduced by
radiation-induced fibrosis (RIF) in the IPAs providing the inflow. By use of
MRI it is possible to visualize the IPAs.
Study objective
The first objective of this study is to test the hypothesis that a higher dose
to the IPAs and corpora cavernosa is correlated to ED after EBRT. The second
objective is to test the hypothesis that RIF in the IPAs and corpora cavernosa
is correlated to ED after EBRT.
Study design
Part A
At first MRI scans will be taken of 5 patients suffering from ED after EBRT.
These MRI scans will be performed to see if it is possible to detect RIF in the
IPAs and corpora cavernosa.
Part B
Before starting EBRT the International Index of Erectile function (IIEF) 26
questionnaire will be filled out and a MRI scan will be performed. This MRI
scan will be matched with the planning CT scan. The IPAs and corpora cavernosa
will be contoured on the matched CT-MRI scan.
An IIEF questionnaire will be sent to the patients at 1 and 2 years after EBRT.
If it is possible to detect RIF in Part A of the present study, then the MRI
scans will be repeated at 1 and 2 years after EBRT. Two radiologists, blinded
for the IIEF scores, will assess whether fibrosis in the IPAs and corpora
cavernosa has occured.
Study burden and risks
One or three MRI scans will be made of each patients. This will require I.V.
gadolinium chelate contrast. This is a very safe form of contrast, which hardly
ever causes side-effects. The benefit for the patient is small, although extra
informatin about the tumor could be attained with the MRI scan.
The IIEF has to be filled out one or three times. This takes about 10 minutes.
The patient population of this study is the same patient population that might
benefit from this study in the future.
Groene Hilledijk
3075EA Rotterdam
NL
Groene Hilledijk
3075EA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Histologically proven prostate cancer
Online setup corrections with gold markers
International Index of Erectile Function erectile function domain score of at least 13
Exclusion criteria
Erectile dysfunction before treatment
Adjuvant hormonal therapy
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 | NL14975.078.07 |