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 |
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.
CSPOR-URO 01:PROSAS-Study
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.
CSPOR-URO 01:PROSAS-Study
Japan |
Prostate cancer
Urology |
Malignancy
NO
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.
Efficacy
Confirmatory
Explanatory
Phase III
Rate of continued active surveillance
-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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
No need to know
2
Treatment
Medicine |
Chlormadinone group:
Chlormadinone acetate at 50 mg/day (PROSTAL® TABLETS 25, 1 tablet at a time, b.i.d.)
Placebo group:
Chlormadinone acetate at 0 mg/day (placebo tablet, 1 tablet at a time, b.i.d.)
65 | years-old | <= |
Not applicable |
Male
(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.
(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.
220
1st name | Hideyuki |
Middle name | |
Last name | Akaza |
Research Center for Advanced Science and Technology, The Universityof Tokyo
Department of Strategic Investigation on Comprehensive Cancer Network
153-8904
4-6-1 Komaba, Meguro-ku, Tokyo 153-8904 JAPAN
03-5452-5314
akazah@med.rcast.u-tokyo.ac.jp
1st name | Akira |
Middle name | |
Last name | Yamao |
Public Health Research Foundation
Comprehensive Support Project for Oncology Research
169-0051
1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo, 169-0051 JAPAN
03-5287-2636
http://www.csp.or.jp/cspor/
info@cso.or.jp
Public Health Research Foundation
Public Health Research Foundation
Non profit foundation
No
No
087-891-2345
nomail@nomail
NO
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
2013 | Year | 11 | Month | 13 | Day |
http://www.csp.or.jp/cspor/
Unpublished
147
Completed
2013 | Year | 12 | Month | 03 | Day |
2013 | Year | 12 | Month | 03 | Day |
2014 | Year | 03 | Month | 26 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 04 | Month | 30 | Day |
2019 | Year | 09 | Month | 30 | Day |
2019 | Year | 12 | Month | 31 | Day |
2013 | Year | 11 | Month | 13 | Day |
2022 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014291
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