A clinical study of generic drug of bicalutamide on the efficacy and the safety in prostate cancer patients

A clinical study of generic drug of bicalutamide on the efficacy and the safety in prostate cancer patients - A clinical study of generic bicalutamide in prostate cancer (GB-study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000005630

Enrollment

Registered

2011-05-23

Start date

2011-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Pathologically confirmed prostate cancer patients who need the treatment with bicalutamide and LH-RH agonist. 1. over 45 years of age 2. PS is 0 to 2 3. Patient whom survival is expected over three months 4. Informed consent

Exclusion criteria

Exclusion criteria: 1. AST (GOT), ALT (GPT), ALP: > 2.5 times of institution standard value. 2. Serum creatinine: > 1.5 times of institution standard value. 3. WBC: < 3,000/mm3 4. Hemoglobin: < 10 g/dl 5. Platelet: < 75,000/mm3 6. Patient with critical illness (liver cirrhosis, liver failure, chronic kidney failure, heart failure, myocardial infarction within 3 months, uncontrolled hypertension, uncontrolled diabetes, serious pulmonary fibrosis, active interstitial pneumonia, immunodeficiency, active double cancer, etc) 7. Patients participating in any clinical researches or clinical trials. 8. Patients who were judged inappropriate for the clinical research by the investigator.

Design outcomes

Primary

Measure	Time frame
PSA level Normalization rate of PSA level	—

Secondary

Measure	Time frame
IPSS Serum hormone Prostate volume Adverse event	—

Countries

Japan

Outcome results