EUCTR2011-004749-41-NL
Active, not recruiting
Not Applicable
The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate-risk prostate carcinoma (NEO-ONE); A randomized controlled trial - NEO-ONE
TweeSteden hospital0 sitesNovember 17, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ocalized prostate cancer
- Sponsor
- TweeSteden hospital
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with low and intermediate risk prostate cancer who are planned for low dose brachytherapy, with a prostate volume between 35 and 50 cc, with a life expectancy of at least 10 years and an ECOG performance status of 2 or less11\.All patients will need to provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 300
Exclusion Criteria
- •Study exclusion criteria are: PSA \=20, Gleason score \=8, Prostate volume \=55 cc, Stage \=T2B, bone metastasis, intraprostatic cavity (e.g. extensive TURP effect), hip abnormalities, use of anticoagulants that are unable to be discontinued for the duration of the operation. Further, we exclude patients that are characterized by
- •·use of hormone suppressive therapy in the past or surgical castration.
- •·use of 5 alfa reductase in the last 6 months
- •·use of estrogens
- •·Taking systemic glucocorticoids
- •·Kidney or liver dysfunction, as biochemically assessed by the glomerular filtration rate of creatinin (MDRD formula; GFR \<50 ml/m2/min) and ASAT and ALAT levels (50% reduction in function)
- •·Cognitive impairments (ECOG performance \<2\)
- •·Negative decision for study participation by the hospitals’ urology\-radiotherapy meeting
- •·A history of myocardial infarction with present symptoms or CAD\-induced (systolic) congestive heart failure
Outcomes
Primary Outcomes
Not specified
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