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


Phase 3
20 Years
79 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to treatment failure (TTF) of bicalutamide

Outcome Time Frame:

time to treatment failure (TTF) of bicalutamide

Safety Issue:

No

Principal Investigator

Seiji Naito, MD, Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Graduate School of Medical Science, Kyushu University

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG0401

NCT ID:

NCT00138008

Start Date:

May 2004

Completion Date:

May 2016

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • radical prostatectomy
  • PSA failure
  • RCT
  • radiation
  • endocrinotherapy
  • Prostatic Neoplasms

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