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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000026

Enrollment

210

Registered

2005-07-22

Start date

2004-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

endocrine therapy radiotherapy +/- endocrine therapy

Eligibility

Sex/Gender

Male

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
TTF of bicalutamide	—

Secondary

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

Countries

Japan

Contacts

Public ContactAkira Yokomizo, MD, Ph.D.

JCOG0401 Coordinating office Department of Urology, Graduate School of Medical Science, Kyushu University

JCOG_sir@ml.jcog.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026