The effects of pretreatment with androgen blocking hormones before brachytherapy for prostate cancer on the course of PSA and testosterone after treatment

Conditions: ocalized prostate cancer
MedDRA version: 14.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-004749-41-NL

Lead Sponsor: TweeSteden hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Assess the effects of 3-month NHT with Eligard 22.5 mg once and Bicalutamide 50 mg daily on the course of testosterone in patients treated with BT for low-intermediate risk localized prostate carcinoma<br><br>to assess the effects of 3-month NHT urinary function, quality of life and prostate volume<br>;Main Objective: Assess the effects of 3-month NHT with Eligard 22.5 mg once and Bicalutamide 50 mg daily on the course of PSA in patients treated with BT for low-intermediate risk localized prostate carcinoma;Primary end point(s): PSA levels ;Timepoint(s) of evaluation of this end point: 3 years, every 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): testosterone levels, quality of life and micturation complaints;Timepoint(s) of evaluation of this end point: 3 years, every 6 months