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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012284
Receipt No. 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 2019/05/20

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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
Institute Public Health Research Foundation
Institute
Department

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 No longer recruiting
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
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.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


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