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RCT of Tri-Modalities with I-125 Brachy Therapy and EBRT and Short or Long Term Hormone Therapy for High-risk Localized Prostate Cancer

Phase 3
Conditions
Prostate Cancer
Registration Number
JPRN-UMIN000003992
Lead Sponsor
Kanazawa University Translational Research Informatices Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
Male
Target Recruitment
340
Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients who have active double cancer 2) Patients with poorly controlled hypertension (i.e., diastolic blood pressure>=120 mm Hg) 3) Patients with severe psychiatric disorders 4) Patients with collagen diseases 5) Patients with poorly controlled diabetes 6) Patients with poorly controlled ischemic cardiac disease 7) Patients who had prior surgery for prostate (transurethral prostatectomy, radical prostatectomy, orchiectomy, other surgery for BPH and/or hyperthermia) 8) Patients who had brachytherapy and/or EBRT 9) Patients who are taking steroid drugs (except for ointment) 10) Patients who are taking other antiandrogen for BPH 11) Patients who had CAB for more than 3 months prior to the registration 12) Patients who are judged inappropriate for the clinical trial by doctors

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Biochemical progression free survival (PSA progression free survival)
Secondary Outcome Measures
NameTimeMethod
1.Overall survival 2.Clinical progression free survival 3.Cause specific survival 4.Time to salvage therapy 5.QOL 6.Adverse Events
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