UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022862 |
|---|---|
| Receipt number | 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 | 2023/06/30 08:31:08 |
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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
1200
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamada |
Organization
the University of Tokyo Hospital
Division name
Department of Urology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
TEL
03-5800-8662
dyamada-tky@umin.net
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamada |
Organization
the University of Tokyo Hospital
Division name
Department of Urology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
TEL
03-5800-8662
Homepage URL
dyamada-tky@umin.net
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Pharma Corporation
Giving to UTokyo
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
University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
Tel
03-5800-8662
IRBjimu-tokyo@umin.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs031180176
Org. issuing International ID_1
Japan Registry of Clinial Trials
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
1200
Results
Case registration completed, follow-up
Results date posted
| 2022 | Year | 06 | Month | 28 | Day |
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026350
