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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022862
Receipt No. R000026350
Scientific Title A prospective randomized controlled study on Suppression of Prostate Cancer by naftopidil (SNAP)
Date of disclosure of the study information 2016/12/01
Last modified on 2018/06/25

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Basic information
Public title A prospective randomized controlled study on Suppression of Prostate Cancer by naftopidil (SNAP)
Acronym Suppression of prostate cancer by
naftopidil (SNAP)
Scientific Title A prospective randomized controlled study on Suppression of Prostate Cancer by naftopidil (SNAP)
Scientific Title:Acronym Suppression of prostate cancer by
naftopidil (SNAP)
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Prospective clinical trials for cancer inhibition of the alpha-1 adrenergic receptor blocking agent have not been reported so far. Therefore, the authors have planned a prospective randomized controlled study on cancer inhibition effects of naftopidil this time.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary evaluation item is the period from the day of registration and diagnosed as prostate cancer.
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Naftopidil is administered to the patient assigned to naftopidil administration group. (3-5 years)
Interventions/Control_2 Not to those assigned to non-administration group.(3-5 years)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
80 years-old >
Gender Male
Key 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
Key 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
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Yamada
Organization the University of Tokyo Hospital
Division name Department of Urology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
TEL 03-5800-8662
Email dyamada-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Yamada
Organization the University of Tokyo Hospital
Division name Department of Urology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
TEL 03-5800-8662
Homepage URL
Email dyamada-tky@umin.net

Sponsor
Institute University of Tokyo
Institute
Department

Funding Source
Organization Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 23 Day
Last modified on
2018 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026350

Research Plan
Registered date File name
2019/02/05 3.b_SNAP_研究計画書ver.5.0_200181115.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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