Prostate cancer
Conditions
Interventions
Intermittent treatment group (arm I)
Continuous treatment group (arm C)
Sponsors
Chiba Prostate Study Group
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: <Pre-registration> 1) An untreated prostate cancer with histologically confirmed adenocarcinoma 2) Stage T1c (ie, non-palpable) N0M0 3) Age under 80 years 4) Serum PSA between 4.1 and 20 ng/ml 5) Performance Status (ECOG) 0 to 2 6) Adequate function of major organs 7) Written informed consent by the patient 8) Being planned for maximum androgen blockade (MAB) by using LH-RH agonist and bicaltamide <Registration> If their PSA levels decrease under 1.0 ng/ml after 6-months introduction treatment, the patient should be registered and randomized.
Exclusion criteria
Exclusion criteria: <Pre-registration> 1) Active malignancy in other organs 2) Serum testosterone under 100 ng/dL or 1 ng/mL 3) Under continuous oral administration of 5-alpha reductase inhibitor or steroids 4) Diagnosed with osteoporosis and under oral treatment 5) Other reasons for being inadequate case judged by the attending doctor <Registration> While 6-months introduction treatment, 1) escape from criteria of prohibited treatments and drugs 2) intake of bicaltamide less than 50% 3) escape from criteria of amount and intervals of LH-RH agonists
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease-specific survival 2. Progression-free survival 3. Adverse events a) Skeltal-related event: fracture, osteoporosis b) Acute coronary syndrome, acute myocardial infarction c) Stroke d) Disorder of laboratory data: Hb, T-Cho, TG, Glucose, HbA1c(NGSP) | — |
Countries
Japan
Contacts
Public ContactHiroshi Ito
National Hospital Organization Chiba Medical Center Office of Clinical Trials, Department of Clinical Research
Outcome results
None listed