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

Email

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


Email

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

Email

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


Research Plan
Registered date File name
2022/06/28 SNAP_研究計画書ver.10.0.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name