To assess the effects of 3-month NHT on the 3-year course of PSA and testosterone in patients treated with BT for low-intermediate risk clinically localized prostate carcinoma. In addition, we would like to assess the effects of 3-month NHT on…
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Levels of PSA and testosterone over the 3-year follow-up period;
Secondary outcome
change in prostate volume+ other important variables: age, urinary complaints,
complications, events.
Background summary
Short-term neoadjuvant hormonal therapy (NHT; i.e. androgen blockage) preceding
brachytherapy for low-intermediate risk clinically localized prostate cancer
(BT) is used successfully to downsize the prostate to make seed implantation
possible. However, NHT also seems to affect PSA levels in these patients, but
this has not been tested before in a randomized clinical trial. In addition, no
information is present on the effects of short-term androgen blockage on
long-term post-BT testosterone levels.
Study objective
To assess the effects of 3-month NHT on the 3-year course of PSA and
testosterone in patients treated with BT for low-intermediate risk clinically
localized prostate carcinoma.
In addition, we would like to assess the effects of 3-month NHT on prostate
volume.
Study design
This is an unblinded, randomised controlled clinical trial.
Intervention
The treatment group is given androgen blockage using Eligard 22.5 mg once and
Bicalutamide 50 mg daily for the duration of three months preceding BT. The
control group will receive BT immediately.
Study burden and risks
Preparatory and follow-up activities coincide with regular medical care. The
only additional procedure is a transrectal ultrasound examination, this will
pose a limited burden on some of the participating patients (only in the
centers that agree to perform this additional ultrasound). In general, it is
not expected that the current study poses any additional risks. Based on our
previous observational study, we expect beneficial effects of 3-month NHT
treatment on quality of life, urinary complaints and PSA levels post-BT.
dr. deelenlaan 5
Tilburg 5042 ad
NL
dr. deelenlaan 5
Tilburg 5042 ad
NL
Listed location countries
Age
Inclusion criteria
These are the inclusioncriteria:
Patients with low and intermediate risk prostate cancer (according to Dutch guidelines)
prostate volume between 35 and 55 cc
a life expectancy of at least 10 years
written informed consent
Exclusion criteria
These are the exclusion criteria:
Contra-indication for BT
use of hormone suppressive therapy in the past or surgical castration.
use of 5 alfa reductase in the last 6 months
use of estrogens
cognitive impairments
negative decision for study participation by the hospitals* urology-radiotherapy meeting
kidney or liver dysfunction
history of myocardial infarction with present symptoms or CAD-induced heart failure
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-004749-41-NL |
| CCMO | NL34027.028.11 |