The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate risk prostate carcinoma (NEO-ONE)
- Conditions
- prostate carcinomaprostate cancer10038588
- Registration Number
- NL-OMON39212
- Lead Sponsor
- TweeSteden ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 400
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Levels of PSA and testosterone over the 3-year follow-up period; </p><br>
- Secondary Outcome Measures
Name Time Method <p>change in prostate volume+ other important variables: age, urinary complaints,<br /><br>complications, events. </p><br>