Suppression of Prostate cancer by Naftopidil

JRCT ID: jRCTs031180176

Registered date:05/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prostate Cancer
• Date of first enrollment: 22/02/2017
• Target sample size: 1200
• Study type: Interventional
• Intervention(s): 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). The initial dose (2 weeks or more) should be 25 mg daily, and thereafter it will be 50 mg daily. However, it is possible to change 25-75 mg a day depending on the symptoms, do not limit the number of times of taking a day or time.

Outcome(s)

• Primary Outcome: The primary evaluation item is the period from the day of registration to diagnosed as prostate cancer.

Secondary Outcome

1) Malignancy of prostate cancer
Malignancy will be evaluated by the cancer property (Gleason score) and extent (positive number of needle biopsies / number of needle biopsies).
2) Rate of apoptotic cells in immunostained specimens of needle biopsy.
3) Doubling time of serum PSA levels from baseline.
4) Cancer incidence in other organs.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 79age old
• Gender: Male

Include criteria

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 40-64 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

Exclude criteria

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) Patients with severe renal dysfunction (serum creatinine of more than 2.0 mg/dl)
11) Patients who are judged inappropriate by investigators

Related Information

• Primary Sponsor: Yamada Daisuke
• Source(s) of Monetary Support: Asahi Kasei Pharma Corporation,The University of Tokyo
• Secondary ID(s): UMIN000022862