A prospective randomized controlled study on Suppression of Prostate Cancer by naftopidil (SNAP)

Not Applicable

• Conditions: Prostate cancer

• Registration Number: JPRN-UMIN000022862
• Lead Sponsor: niversity of Tokyo

Brief Summary

Case registration completed, follow-up

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-01
• Last Update Posted: 17 October 2023
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Male
• Target Recruitment: 1200

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary evaluation item is the period from the day of registration and diagnosed as prostate cancer.

Secondary Outcome Measures

Name	Time	Method
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