UMIN-CTR Clinical Trial

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

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Basic information

Public title

Efficacy of intermittent versus continuous endocrine therapy on localized and non-palpable prostate cancer: a multi-center randomized controlled trial

Acronym

Intermittent vs. continuous endocrine therapy for T1cN0M0 prostate cancer : a multi-center randomized controlled trial (INCEL trial)

Scientific Title

Efficacy of intermittent versus continuous endocrine therapy on localized and non-palpable prostate cancer: a multi-center randomized controlled trial

Scientific Title:Acronym

Intermittent vs. continuous endocrine therapy for T1cN0M0 prostate cancer : a multi-center randomized controlled trial (INCEL trial)

Region

Japan


Condition

Condition

Prostate cancer

Classification by specialty

Endocrinology and Metabolism Hematology and clinical oncology Endocrine surgery
Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To verify whether intermittent endocrine therapy is not inferior to continuous therapy for localized and non-palpable (T1cN0M0) prostate cancer.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Overall survival

Key secondary outcomes

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)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Intermittent treatment group (arm I)

Interventions/Control_2

Continuous treatment group (arm C)

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


Not applicable

Age-upper limit

80 years-old >

Gender

Male

Key inclusion criteria

<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.

Key exclusion criteria

<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

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naohide Sato

Organization

National Hospital Organization Chiba Medical Center

Division name

Department of Urology

Zip code


Address

Tsubakimori 4-1-2, Chuo-ku, Chiba, 260-8606 Japan

TEL

+81-43-251-5311

Email

naohide-sato.5959momo@w4.dion.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Ito

Organization

National Hospital Organization Chiba Medical Center

Division name

Office of Clinical Trials, Department of Clinical Research

Zip code


Address

Tsubakimori 4-1-2, Chuo-ku, Chiba, 260-8606 Japan

TEL

+81-43-251-5348

Homepage URL

http://www.hosp.go.jp/~chiba/

Email

itou-phc@nho-chiba.hosp.go.jp


Sponsor or person

Institute

Chiba Prostate Study Group

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

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


Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 01 Day


Related information

URL releasing protocol

http://www.hosp.go.jp/~chiba/

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Open public recruiting

Date of protocol fixation

2012 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 01 Day

Last follow-up date

2026 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2026 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2012 Year 09 Month 03 Day

Last modified on

2014 Year 06 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010272


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name