Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00138008

Enrollment

200

Registered

2005-08-30

Start date

2004-05-31

Completion date

2016-05-31

Last updated

2016-09-22

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

Conditions

Prostate Cancer

Keywords

prostate cancer, radical prostatectomy, PSA failure, RCT, radiation, endocrinotherapy

Brief summary

The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for PSA failure after radical prostatectomy.

Detailed description

A randomized controlled trial is conducted in Japan to evaluate radiotherapy followed by endocrine therapy for PSA failure after radical prostatectomy. Patients who have PSA failure after radical prostatectomy under a diagnosis of localized prostate cancer (T1-2 N0M0) are randomized into treatment group of either radiotherapy followed by endocrine therapy or endocrine therapy alone. Urologic Oncology Study Group (UOSG) in the JCOG composed of 36 specialized institutions will recruit 200 patients. The primary endpoint is time to treatment failure (TTF) of bicalutamide and secondary endpoints are TTF of protocol treatment, progression free survival, overall survival, adverse events and quality of life (QOL). The Clinical Trial Review Committee of the Japan Clinical Oncology Group (JCOG) approved the protocol on April 13, 2004, and the study was activated on May 17, 2004.

Interventions

DRUGendocrine therapy

Drug: endocrine therapy

PROCEDUREradiotherapy

Procedure/Surgery: radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 79 Years

Healthy volunteers

Inclusion criteria

* A diagnosis of localized prostate cancer (clinical stage T1-2N0M0) which is treated by radical prostatectomy * Pathological stage: pT0/2/3 and pN0/x * Serum level of PSA once reached \< 0.1 ng/ml after radical prostatectomy and then increased 0.4 ng/ml * Serum level of PSA 1.0 ng/ml at entry * No clinical recurrence based on abdominal and pelvic computed tomography, and a bone scan * No history of chemotherapy or radiation therapy or endocrine therapy for any cancer * Ages 20 to 79 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * No blood transfusion within 28 days of entry * Sufficient organ function within 28 days of entry * Provided written informed consent

Exclusion criteria

* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ * Mental disease or mental symptoms which would affect participant's decision to participate * Continuous medication with steroids (exclude external use of steroids for skin) * Ischemic heart disease or arrhythmia which needs medical treatment * Poorly controlled hypertension * Poorly controlled diabetes mellitus * History of cerebral infarction or myocardial infarction within 6 months * Liver cirrhosis * Interstitial pneumonia which requires ventilation assistance, oxygen inhalation, steroids, or diuretic medicine

Design outcomes

Primary

Measure	Time frame
time to treatment failure (TTF) of bicalutamide	time to treatment failure (TTF) of bicalutamide

Secondary

Measure	Time frame
TTF of protocol treatment	TTF of protocol treatment
clinical progression free survival	time to clinical progression
overall survival	overall
adverse events	overall
patient-reported quality of life	1 year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026