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Phase III clinical trial to study quality of life in prostate cancer patients by randomizing anti-androgen versus total androgen blockage prior to curative intended radiation therapy.
Primary objective: To study the difference in quality of life in relation to anti-androgen versus total androgen blockage. Exploratory parameters: ▪ Time to PSA relapse * Time to symptom giving metastasis * Overall survival Patients with localized /locally advanced prostate cancer were subject to treatment with curative intention. They could be divided into three groups according to the risk of metastasis. Mainly intermediate risk group of patients were included in this study. Patients with low risk could be included if they were subject to neo-adjuvant hormonal therapy. Different risk groups were defined as below: Low risk group: PSA ≤10 ng/ml Gleason score ≤ 6 Tumour stage ≤ T2b Intermediate risk group: Presence of 1-2 factors of high risk. High risk group: PSA \>10 ng/ml Gleason score ≥7 Tumour stage T2c - T3b
Age
All ages
Sex
MALE
Healthy Volunteers
No
Start Date
June 1, 2005
Primary Completion Date
April 1, 2009
Completion Date
July 1, 2012
Last Updated
March 6, 2015
110
ACTUAL participants
Bicalutamide
DRUG
Lead Sponsor
Karolinska University Hospital
NCT05691465
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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