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

This study is currently recruiting participants.
Verified June 2010 by Japan Clinical Oncology Group
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00138008
First received: August 29, 2005
Last updated: June 13, 2010
Last verified: June 2010

August 29, 2005
June 13, 2010
May 2004
May 2016   (final data collection date for primary outcome measure)
time to treatment failure (TTF) of bicalutamide [ Time Frame: time to treatment failure (TTF) of bicalutamide ] [ Designated as safety issue: No ]
TTF of bicalutamide
Complete list of historical versions of study NCT00138008 on ClinicalTrials.gov Archive Site
  • TTF of protocol treatment [ Time Frame: TTF of protocol treatment ] [ Designated as safety issue: No ]
  • clinical progression free survival [ Time Frame: time to clinical progression ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: overall ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: overall ] [ Designated as safety issue: Yes ]
  • patient-reported quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • TTF of protocol treatment
  • clinical progression free survival
  • overall survival
  • adverse events
  • patient-reported quality of life
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: endocrine therapy
    Drug: endocrine therapy
  • Procedure: radiotherapy
    Procedure/Surgery: radiotherapy
  • Active Comparator: 1
    Drug: endocrine therapy
    Intervention: Drug: endocrine therapy
  • Experimental: 2
    Procedure/Surgery: radiotherapy
    Intervention: Procedure: radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
May 2016
May 2016   (final data collection date for primary outcome measure)

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
Male
20 Years to 79 Years
No
Contact: Akira Yokomizo, MD, Ph.D. 81-92-642-5603 JCOG_sir@ml.jcog.jp
Contact: Seiji Naito, MD, Ph.D. 81-92-642-5603 JCOG_sir@ml.jcog.jp
Japan
 
NCT00138008
JCOG0401, C000000026
Yes
Japan Clinical Oncology Group
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Seiji Naito, MD, Ph.D. Graduate School of Medical Science, Kyushu University
Japan Clinical Oncology Group
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP