UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012284
Receipt number R000014291
Scientific Title Multicenter, randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of low-dose chlormadinone acetate on the rate of continued active surveillance of patients with low-risk prostate cancer.
Date of disclosure of the study information 2013/11/13
Last modified on 2022/11/21 13:13:56

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Basic information

Public title

Multicenter, randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of low-dose chlormadinone acetate on the rate of continued active surveillance of patients with low-risk prostate cancer.

Acronym

CSPOR-URO 01:PROSAS-Study

Scientific Title

Multicenter, randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of low-dose chlormadinone acetate on the rate of continued active surveillance of patients with low-risk prostate cancer.

Scientific Title:Acronym

CSPOR-URO 01:PROSAS-Study

Region

Japan


Condition

Condition

Prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of chlormadinone acetate on the rate of continued active surveillance by administration of low-dose chlormadinone acetate or placebo to patients with low-risk prostate cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

Rate of continued active surveillance

Key secondary outcomes

-PSA (prostate-specific antigen) level
-Testosterone level
-Successful treatment period
-Tumor progression level (measured by Gleason score, TNM stage, exacerbation rate and incidence of distant metastasis, etc.)
-QOL (SF-8, EPIC, I-PSS)
-Safety (measured by incidence of adverse events and discontinuation rate due to adverse events)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Chlormadinone group:
Chlormadinone acetate at 50 mg/day (PROSTAL® TABLETS 25, 1 tablet at a time, b.i.d.)

Interventions/Control_2

Placebo group:
Chlormadinone acetate at 0 mg/day (placebo tablet, 1 tablet at a time, b.i.d.)

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

(1) A patient who has been diagnosed with prostate cancer based on histology (biopsy).
(2) A patient with T1c, N0, M0, Gleason score <= 6, PSA <= 10 ng/mL.
(3) A patient with untreated prostate cancer.
(4) If a patient is already receiving AS, the AS must have been started within the previous 6 months.
(5) A male patient aged 65 years or older at the time of enrollment.
(6) A patient with an ECOG performance status (PS) of 0 or 1.
(7) A patient who has provided written informed consent to participate in this study.

Key exclusion criteria


(1) A patient with active double cancer (synchronous double cancer and metachronous double cancer with a disease-free interval of less than 5 years, excluding carcinoma in situ and intramucosal carcinoma lesions, which are considered to be cured by local treatment).
(2) A patient with serious hepatic disorder and hepatic disease.
(3) A patient with serious disease (e.g., chronic renal failure, cardiac failure, myocardial infarction within the previous 3 months, uncontrolled hypertension, uncontrolled diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonia, immunodeficiency, etc.).
(4) A patient with serious drug allergy/hypersensitivity.
(5) A patent with active urogenital infection.
(6) A patient with prostatitis with the chief symptom of pain.
(7) A patient with severe lower urinary tract symptoms (LUTS) requiring surgical intervention.
(8) A patient with a history of surgical treatment of the prostate.
(9) A patient who is not allowed to discontinue treatment with antiandrogen or 5a-reductase inhibitor.
(10) A patient with an expected survival of less than 5 years.
(11) A patient whom the investigator considers to be ineligible as a subject.

Target sample size

220


Research contact person

Name of lead principal investigator

1st name Hideyuki
Middle name
Last name Akaza

Organization

Research Center for Advanced Science and Technology, The Universityof Tokyo

Division name

Department of Strategic Investigation on Comprehensive Cancer Network

Zip code

153-8904

Address

4-6-1 Komaba, Meguro-ku, Tokyo 153-8904 JAPAN

TEL

03-5452-5314

Email

akazah@med.rcast.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Yamao

Organization

Public Health Research Foundation

Division name

Comprehensive Support Project for Oncology Research

Zip code

169-0051

Address

1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo, 169-0051 JAPAN

TEL

03-5287-2636

Homepage URL

http://www.csp.or.jp/cspor/

Email

info@cso.or.jp


Sponsor or person

Institute

Public Health Research Foundation

Institute

Department

Personal name



Funding Source

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

No

Address

No

Tel

087-891-2345

Email

nomail@nomail


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

群馬大学医学部附属病院
群馬県立がんセンター
伊勢崎市民病院
前橋赤十字病院
善衆会病院
奈良県立医科大学
済生会中和病院
大和高田市立病院
市立奈良病院
大阪暁明館病院
平尾病院
多根総合病院
高井病院
松阪中央総合病院
金沢大学附属病院
能美市立病院
市立敦賀病院
JCHO金沢病院
石川県立中央病院
金沢有松病院
水戸済生会総合病院
茨城県立中央病院
香川大学医学部附属病院
KKR高松病院
水島協同病院
キナシ大林病院
小豆島中央病院
順天堂大学医学部附属順天堂医院
順天堂大学医学部附属静岡病院
順天堂大学医学部附属練馬病院
浜松医科大学医学部附属病院
中東遠総合医療センター
宮崎大学医学部附属病院
千代田病院
栃木県立がんセンター
東京女子医科大学八千代医療センター
総合病院国保旭中央病院


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 13 Day


Related information

URL releasing protocol

http://www.csp.or.jp/cspor/

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

147

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

Completed

Date of protocol fixation

2013 Year 12 Month 03 Day

Date of IRB

2013 Year 12 Month 03 Day

Anticipated trial start date

2014 Year 03 Month 26 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 04 Month 30 Day

Date trial data considered complete

2019 Year 09 Month 30 Day

Date analysis concluded

2019 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 11 Month 13 Day

Last modified on

2022 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014291


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name