Clinical trial · Interventional
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)
NCT00138008CI-TRIAL-00023993completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endocrine therapy | Drug | Hormone Therapy | ALIAS |
| radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Drug: endocrine therapy
- interventionNames
- Drug: endocrine therapy
- type
- EXPERIMENTAL
- label
- 2
- description
- Procedure/Surgery: radiotherapy
- interventionNames
- Procedure: radiotherapy
Primary outcomes (1)
- measure
- time to treatment failure (TTF) of bicalutamide
- timeFrame
- time to treatment failure (TTF) of bicalutamide
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.