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

Sponsor:	Japan Clinical Oncology Group
Collaborator:	Ministry of Health, Labour and Welfare, Japan
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00138008

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: endocrine therapy Procedure: radiotherapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial to Evaluate Radiotherapy Followed by Endocrine Therapy vs. Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy (JCOG0401)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:

time to treatment failure (TTF) of bicalutamide [ Time Frame: time to treatment failure (TTF) of bicalutamide ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	May 2004
Estimated Study Completion Date:	May 2016
Estimated Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Drug: endocrine therapy	Drug: endocrine therapy Drug: endocrine therapy
2: Experimental Procedure/Surgery: radiotherapy	Procedure: radiotherapy Procedure/Surgery: radiotherapy

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.

Eligibility

Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138008

Contacts

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

Show 34 Study Locations

Sponsors and Collaborators

Japan Clinical Oncology Group

Ministry of Health, Labour and Welfare, Japan

Investigators

Study Chair:

Seiji Naito, MD, Ph.D.

Graduate School of Medical Science, Kyushu University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Japan Clinical Oncology Group ( Japan Clinical Oncology Group )
Study ID Numbers:	JCOG0401, C000000026
Study First Received:	August 29, 2005
Last Updated:	August 2, 2009
ClinicalTrials.gov Identifier:	NCT00138008 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:

prostate cancer
radical prostatectomy
PSA failure

RCT
radiation
endocrinotherapy

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 04, 2010