Prostate Cancer
Conditions
Interventions
After treated by CAB for 3 months, Brachytherapy and EBRT to be applied. During this treatment, CAB is continued. After that, adjuvant long term hormonal therapy (24 months) to be applied.
After tre
Sponsors
Kanazawa University Translational Research Informatices Center
Jikei University School of Medicine National Hospital Organization Tokyo Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Patients with high risk prostate cancer which is defined by PSA value, clinical stage or Gleason score determined by the central pathological judgment. High risk is the case where at least one of the following three factors is satisfied (1) PAS>20 ng/mL prior to CAB (2) Clinical stage of T2c or T3a (3) GS>=8 by central pathologists 2) Performance status 0-1 (ECOG) 3) Age>=40 and <80 when obtaining the written informed consent 4) Patients who satisfy the following (within 14 days prior to the CAB) a) Peripheral blood test : WBC>=3.0x103/microL, hemoglobin>=10.0 g/dL, blood plate>=10x104/microL b) Biological test: serum creatinine<=2.0 mg/dL, AST(GOT)<=100 IU/L, ALT(GPT)<=100 IU/L 5) Written informed consent must be obtained from patient
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical progression free survival (PSA progression free survival) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival 2. Clinical progression free survival 3. Cause specific survival 4. Time to salvage therapy 5. QOL 6. Adverse Events | — |
Countries
Japan
Contacts
Public ContactNoriko MOMMA
National Hospital Organization Tokyo Medical Center National Institute of Sensory Organs TRIP secretariat
Outcome results
None listed