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

• Register: JPRN
• Last refreshed on: 26 April 2013
• Main ID: JPRN-C000000026
• Date of registration: 22/07/2005
• Primary sponsor: Japan Clinical Oncology Group(JCOG)
• Public title: Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy(JCOG0401)
• Date of first enrolment: 2004/05/01
• Target sample size: 210
• Recruitment status: No longer recruiting
• URL: http://www.umin.ac.jp/ctr/index.htm
• Study type: Interventional
• Study design: Parallel Randomized

Countries of recruitment

Japan

Contacts

• Name: Akira Yokomizo, MD, Ph.D.
• Affiliation: JCOG0401 Coordinating office Department of Urology, Graduate School of Medical Science, Kyushu University

• Name: Keisuke Kanato
• Affiliation: JCOG Operations Office Study Coordinating Section

Key inclusion & exclusion criteria

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.
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

Age minimum: 20years-old
Age maximum: 79years-old
Gender: Male

Health Condition(s) or Problem(s) studied

prostate cancer

Intervention(s)

endocrine therapy
radiotherapy +/- endocrine therapy

Primary Outcome(s)

TTF of bicalutamide

Secondary Outcome(s)

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

Secondary ID(s)

NCT00138008

Source(s) of Monetary Support

Ministry of Health, Labour and Welfare