Prostate cancer
Conditions
Interventions
Naftopidil is administered to the patient assigned to naftopidil administration group. (3-5 years)
Not to those assigned to non-administration group.(3-5 years)
Sponsors
University of Tokyo
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Criteria for selection 1) Patients whose cancer is not proved by the prostatic needle biopsy (for more than eight spots) performed within the past three months 2) Male patients at the aged of 40 years old or older and younger than 80 years at the time when the consent is acquired 3) Patients whose highest value within 6 months serum PSA levels are abnormal before the prostatic needle biopsy (more than 3.0 ng/ml for 50-64 years old , more than 3.5 ng/ml for 65-69 years old, more than 4.0 ng/ml for 70 years old or older) 4) Patients who are given sufficient description about participation in this study and sufficiently understand it, providing their consent in document by their own free will 5) Patients having prostatic hyperplasia
Exclusion criteria
Exclusion criteria: (2) Exclusion criteria 1) Patients who were given a diagnosis of prostate cancer or prostatic atypical (Atypical) (PIN: prostatic intraepithelial neoplasia is accepted) 2) Patients with the history of oral administration of anti-androgenic medicine or 5 alpha reductase inhibitor in the 6 months before the measurement of the serum PSA value the last time before prostate needle biopsy 3) Patients with the history of oral administration of naftopidil in the 3 months before prostate needle biopsy 4) Patients not having indication for oral administration of alpha1 adrenergic receptor blockers in patients with severe dysuria accompanied with prostatic hyperplasia (states such as urinary retention, urethral catheter placement, the intermittent urethral catheterization) 5) Patients who are currently taking steroid medicine on consecutive days 6) Patients with active urogenital infection (including acute prostatitis) 7) Patients with the history of malignant tumor (however, the cases that the disease was cured radically) 8) Patients who received antineoplastic agents (including therapeutic purposes other than malignant tumors) in the last 3 months before biopsy (for sustained release formulations, during drug release period) 9) Patients with severe hepatic dysfunction (AST (GOT) or ALT (GPT) of more than 100IU) 10) Patient with severe renal dysfunction (serum creatinine of more than 2.0 mg/dl) 11) Patients who are judged inappropriate by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary evaluation item is the period from the day of registration and diagnosed as prostate cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Malignancy of prostate cancer Malignancy is evaluated by properties of the cancer (Gleason score) and extent (positive number of needle biopsy / number of needle biopsy) 2) Rate of apoptosis of the prostatic cancer part and non-cancer part 3) Time before the serum PSA level is doubled from the baseline (doubling time) 4) Cancer incidence for other organs | — |
Countries
Japan
Contacts
Public ContactDaisuke Yamada
the University of Tokyo Hospital Department of Urology
Outcome results
None listed