Unique ID issued by UMIN | UMIN000008843 |
---|---|
Receipt number | R000010272 |
Scientific Title | Efficacy of intermittent versus continuous endocrine therapy on localized and non-palpable prostate cancer: a multi-center randomized controlled trial |
Date of disclosure of the study information | 2012/10/01 |
Last modified on | 2014/06/11 14:14:59 |
Efficacy of intermittent versus continuous endocrine therapy on localized and non-palpable prostate cancer: a multi-center randomized controlled trial
Intermittent vs. continuous endocrine therapy for T1cN0M0 prostate cancer : a multi-center randomized controlled trial (INCEL trial)
Efficacy of intermittent versus continuous endocrine therapy on localized and non-palpable prostate cancer: a multi-center randomized controlled trial
Intermittent vs. continuous endocrine therapy for T1cN0M0 prostate cancer : a multi-center randomized controlled trial (INCEL trial)
Japan |
Prostate cancer
Endocrinology and Metabolism | Hematology and clinical oncology | Endocrine surgery |
Urology |
Malignancy
NO
To verify whether intermittent endocrine therapy is not inferior to continuous therapy for localized and non-palpable (T1cN0M0) prostate cancer.
Bio-equivalence
Confirmatory
Pragmatic
Phase III
Overall survival
1. Disease-specific survival
2. Progression-free survival
3. Adverse events
a) Skeltal-related event: fracture, osteoporosis
b) Acute coronary syndrome, acute myocardial infarction
c) Stroke
d) Disorder of laboratory data: Hb, T-Cho, TG, Glucose, HbA1c(NGSP)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Maneuver |
Intermittent treatment group (arm I)
Continuous treatment group (arm C)
Not applicable |
80 | years-old | > |
Male
<Pre-registration>
1) An untreated prostate cancer with histologically confirmed adenocarcinoma
2) Stage T1c (ie, non-palpable) N0M0
3) Age under 80 years
4) Serum PSA between 4.1 and 20 ng/ml
5) Performance Status (ECOG) 0 to 2
6) Adequate function of major organs
7) Written informed consent by the patient
8) Being planned for maximum androgen blockade (MAB) by using LH-RH agonist and bicaltamide
<Registration>
If their PSA levels decrease under 1.0 ng/ml after 6-months introduction treatment, the patient should be registered and randomized.
<Pre-registration>
1) Active malignancy in other organs
2) Serum testosterone under 100 ng/dL or 1 ng/mL
3) Under continuous oral administration of 5-alpha reductase inhibitor or steroids
4) Diagnosed with osteoporosis and under oral treatment
5) Other reasons for being inadequate case judged by the attending doctor
<Registration>
While 6-months introduction treatment,
1) escape from criteria of prohibited treatments and drugs
2) intake of bicaltamide less than 50%
3) escape from criteria of amount and intervals of LH-RH agonists
600
1st name | |
Middle name | |
Last name | Naohide Sato |
National Hospital Organization Chiba Medical Center
Department of Urology
Tsubakimori 4-1-2, Chuo-ku, Chiba, 260-8606 Japan
+81-43-251-5311
naohide-sato.5959momo@w4.dion.ne.jp
1st name | |
Middle name | |
Last name | Hiroshi Ito |
National Hospital Organization Chiba Medical Center
Office of Clinical Trials, Department of Clinical Research
Tsubakimori 4-1-2, Chuo-ku, Chiba, 260-8606 Japan
+81-43-251-5348
http://www.hosp.go.jp/~chiba/
itou-phc@nho-chiba.hosp.go.jp
Chiba Prostate Study Group
None
Self funding
NO
千葉大学医学部附属病院(千葉県)、大阪医科大学附属病院(大阪府)、国立病院機構四国がんセンター(愛媛県)、東京慈恵会医科大学附属柏病院(千葉県)、東京女子医科大学八千代医療センター(千葉県)、帝京大学ちば総合医療センター(千葉県)、東邦大学医療センター佐倉病院(千葉県)、千葉県がんセンター(千葉県)、国立病院機構千葉医療センター(千葉県)、千葉市立青葉病院(千葉県)、旭中央病院(千葉県)、JCHO東京新宿メディカルセンター(東京都)、船橋市立医療センター(千葉県)、深谷赤十字病院(埼玉県)、久喜総合病院(埼玉県)、JCHO船橋中央病院(千葉県)、熊谷総合病院(埼玉県)、みはま病院(千葉県)、成田赤十字病院(千葉県)、山王病院(千葉県)、済生会習志野病院(千葉県)、済生会宇都宮病院(栃木県)、横浜労災病院(神奈川県)、さかい泌尿器科医院(千葉県)、わたべクリニック(千葉県)、ほか
2012 | Year | 10 | Month | 01 | Day |
http://www.hosp.go.jp/~chiba/
Unpublished
Open public recruiting
2012 | Year | 08 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2026 | Year | 09 | Month | 30 | Day |
2026 | Year | 09 | Month | 30 | Day |
2012 | Year | 09 | Month | 03 | Day |
2014 | Year | 06 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010272
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