title: Randomized controlled trial to evaluate radiotherapy +/- endocrine therapy versus endocrine therapy alone for PSA failure after radical prostatectomy: Japan Clinical Oncology Group Study JCOG 0401.
abstract: A randomized controlled trial has started in Japan to evaluate radiotherapy and endocrine therapy for prostate-specific antigen (PSA) failure after radical prostatectomy. Patients who have PSA failure after radical prostatectomy for localized prostate cancer (T1-2N0M0) are randomized into treatment groups of either radiotherapy +/- endocrine therapy or endocrine therapy alone. The Urologic Oncology Study Group (UOSG) in the Japan Clinical Oncology Group (JCOG) composed of 36 specialized institutions will recruit 200 patients. The primary end-point is time to treatment failure (TTF) of bicalutamide, and secondary end-points are TTF of protocol treatment, progression-free survival, overall survival, adverse events and quality of life (QOL). The Clinical Trial Review Committee of the JCOG approved the protocol on April 13, 2004, and the study was activated on May 17, 2004.
authors.affiliation: Department of Urology, Graduate School of Medical Science, Kyushu University, Higashi-ku, Fukuoka 812-8582, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Yokomizo
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kawamoto
authors.forename: Keiji
authors.initials: K
authors.lastname: Nihei
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishizuka
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Kakehi
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Tobisu
authors.forename: Seiji
authors.initials: S
authors.lastname: Naito
mesh_terms: D000328:Adult; D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use; D000813:Anilides / Q000627:therapeutic use; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D023381:Endpoint Determination; D017273:Goserelin / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D017430:Prostate-Specific Antigen / Q000097:blood*; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D011788:Quality of Life; D011879:Radiotherapy Dosage; D015996:Survival Rate; D014105:Tosyl Compounds
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D018931:Antineoplastic Agents, Hormonal; D009570:Nitriles; D014105:Tosyl Compounds; D017273:Goserelin; C053541:bicalutamide; D017430:Prostate-Specific Antigen