UMIN-CTR Clinical Trial

Public title

Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy(JCOG0401)

Acronym

Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy(JCOG0401)

Scientific Title

Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy(JCOG0401)

Scientific Title:Acronym

Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy(JCOG0401)

Region

Japan

Condition

prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for PSA failure after radical prostatectomy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

TTF of bicalutamide

Key secondary outcomes

TTF of protocol treatment, clinical progression free survival, overall survival, adverse events and patient-reported quality of life

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

endocrine therapy

Interventions/Control_2

radiotherapy +/- endocrine therapy

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

79

years-old

>=

Gender

Male

Key inclusion criteria

1) A diagnosis of localized prostate cancer (clinical stage T1-2N0M0) which is treated by radical prostatectomy;
2) pathological stage: pT0/2/3 and pN0/x;
3) the serum level of PSA once reached < 0.1 ng/ml after radical prostatectomy and then increased 0.4 ng/ml;
4) the serum level of PSA 1.0 ng/ml at the entry
5) no clinical recurrence based on abdominal and pelvic computed tomography, and a bone scan;
6) no history of chemotherapy or radiation therapy or endocrine therapy for any cancer;
7) age 20 and 79 years;
8) an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
9) no blood transfusion within 28 days of entry;
10) a sufficient organ function within 28 days of entry and
11) provided written informed consent.

Key exclusion criteria

1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ;
2) mental disease or mental symptoms which would affect participant's decision to participate;
3) continuous medication of steroids (exclude external use of steroids for skin) ;
4) ischemic heart disease or arrhythmia which needs medical treatment;
5) poorly controlled hypertension;
6) poorly controlleddiabetes mellitus;
7) history of cerebral infarction or myocardial infarction within 6 months;
8) liver cirrhosis
9) interstitial pneumonia which requires ventilation assistance, oxygen inhalation, steroids, or diuretic medicine

Target sample size

210

Name of lead principal investigator

1st name
Middle name
Last name	Seiji Naito, MD, Ph.D.

Organization

Graduate School of Medical Science, Kyushu University

Division name

Department of Urology

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, 812-8582, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Akira Yokomizo, MD, Ph.D.

Organization

JCOG0401 Coordinating office

Division name

Department of Urology, Graduate School of Medical Science, Kyushu University

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, 812-8582, Japan

TEL

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT00138008

Org. issuing International ID_1

ClinicalTrials.gov by NLM

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院（北海道）
札幌医科大学（北海道）
弘前大学医学部附属病院（青森県）
東北大学病院（宮城県）
宮城県立がんセンター（宮城県）
秋田大学医学部（秋田県）
山形大学医学部（山形県）
筑波大学臨床医学系（茨城県）
栃木県立がんセンター（栃木県）
防衛医科大学校（埼玉県）
千葉大学医学部（千葉県）
国立がん研究センター中央病院（東京都）
慶應義塾大学病院（東京都）
東京慈恵会医科大学附属病院（東京都）
帝京大学医学部（東京都）
北里大学医学部（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
新潟大学医歯学総合病院（新潟県）
山梨大学医学部（山梨県）
信州大学医学部（長野県）
浜松医科大学（静岡県）
静岡県立静岡がんセンター（静岡県）
名古屋大学医学部（愛知県）
三重大学医学部（三重県）
京都大学医学部附属病院（京都府）
大阪府立病院機構大阪府立成人病センター（大阪府）
神戸大学医学部（兵庫県）
奈良県立医科大学（奈良県）
鳥取大学医学部（鳥取県）
島根大学医学部（島根県）
山口大学医学部附属病院（山口県）
香川大学医学部（香川県）
国立病院機構四国がんセンター（愛媛県）
国立病院機構九州がんセンター（福岡県）
久留米大学医学部（福岡県）
九州大学病院（福岡県）
原三信病院（福岡県）
熊本大学医学部（熊本県）
鹿児島大学医学部・歯学部附属病院（鹿児島県）

Date of disclosure of the study information

2005

Year

07

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2004

Year

04

Month

13

Day

Date of IRB

Anticipated trial start date

2004

Year

05

Month

01

Day

Last follow-up date

2016

Year

05

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Yokomizo A, Tobisu K, Kawamoto H, Nihei K, Ishizuka N, Naito S. Randomized Controlled Trial to Evaluate Radiation plus Endocrine Therapy or Endocrine Therapy alone for PSA failure after radical prostatectomy: Japan Clinical Oncology Group Study JCOG 0401. Jpn. J. Clin. Oncol., 35:34-36, 2005.

Registered date

2005

Year

07

Month

22

Day

Last modified on

2012

Year

09

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000059