prostate cancer
Conditions
Interventions
LHRH-agonist is injected all participants until 6 months after completing EBRT every 4 weeks or 3 months according to the drug information. Adjuvant long-term androgen deprivation therapy (ADT) grou
Sponsors
Department of Hygiene and Preventive Medicine, School of Health Sciences and Nursing, University of Tokyo
National Cancer Center Hospital Sapporo Medical University School of Medicine The Cancer Institute Hospital of JFCR Graduate School of Medical Sciences, Kyushu University Osaka Medical Center for Cancer and Cardiovascular Diseases Tokyo Metropolitan Cancer and Infections disease Center Komagome Hospital Koshigaya Hospital, Dokkyo Medical University Kitazato University Hospital Tokyo Medical Center Shikoku Cancer Center Ibaraki Prefectural Central Hospital and Cancer Center Gunma Prefe
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Pathologically confirmed prostate cancer 2)Clinical stage is T3N0M0 or T4N0M0 (bladder neck invasion only) 3)Untreated prostate cancer 4)Performance status is 0 or 1 5)Aged younger than 80 years 6)Laboratory data is fit the following criteria within 14 days before the registration a)White blood cell is 3.0X103/ul or higher, Hemoglobin levels is 10.0g/dl or higher and Platelet is 10X10000/ul or higher b) Serum creatinine levels is 2.0 mg/dl or lower, GOT is 100 U/L or lower, GPT is 100 U/L or lower 7) Restriction of concomitant medication and treatment a) No history of undergoing prostate surgery for benign prostatic hyperplasia, which includes transurethral resection of the prostate (TUR-P), subcapsular prostatectomy, or other operation or thermotherapy to the prostate. b) No medication of adrenocortical steroid agent c) No medication of antiandrogen for benign prostatic hyperplasia 8) Written informed consent must be done and get agreement on the enrollment of the present study by participants
Exclusion criteria
Exclusion criteria: 1) Having uncontrolled other malignancy 2) Having uncontrolled hypertension (Diastolic blood pressure 120mmHg or higher) 3) Having severe disease in brain or central nerve system 4) Having collagen disease 5) Having uncontrolled diabetes mellitus 6) Having any other problem that researchers judge unfit for the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| biochemical relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, cancer-specific survival and longitudinal QOL assessment | — |
Countries
Japan
Contacts
Public ContactAtsuko Ohyama
Gunma University Urology
Outcome results
None listed