Phase III Trial Comparing Whole-Pelvic Versus Prostate-Only Radiotherapy and Neoadjuvant Versus Adjuvant Combined Androgen Suppression: Radiation Therapy Oncology Group 9413

• Published in: Journal of clinical oncology Vol. 21; no. 10; pp. 1904 - 1911
• Main Authors: ROACH, M. III, DESILVIO, M, HAN, S, THOMAS, C. R, SHIPLEY, W. S, LAWTON, C, UHL, V, MACHTAY, M, SEIDER, M. J, ROTMAN, M, JONES, C, ASBELL, S. O, VALICENTI, R. K
• Format: Journal Article
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 15.05.2003; Lippincott Williams & Wilkins
• Subjects: Aged; Aged, 80 and over; Androgen Antagonists - administration & dosage; Antineoplastic agents; Antineoplastic Agents, Hormonal - administration & dosage; Biological and medical sciences; California; Chemotherapy, Adjuvant; Combined Modality Therapy; Combined treatments (chemotherapy of immunotherapy associated with an other treatment); Disease-Free Survival; Drug Administration Schedule; Humans; Lymphatic Metastasis; Male; Massachusetts; Medical sciences; Michigan; Middle Aged; Neoadjuvant Therapy; New York City; Ohio; Pennsylvania; Pharmacology. Drug treatments; Proportional Hazards Models; Prospective Studies; Prostate-Specific Antigen - blood; Prostatic Neoplasms - blood; Prostatic Neoplasms - drug therapy; Prostatic Neoplasms - mortality; Prostatic Neoplasms - pathology; Prostatic Neoplasms - radiotherapy; Radiotherapy, Conformal; Texas; Treatment Outcome; Wisconsin; New York City; Massachusetts; Texas; Ohio; California; Wisconsin; Michigan; Pennsylvania; Adenocarcinoma; Antineoplastic agent; Phase III trial; Agonist; Prostate disease; Adjuvant treatment; Gonadotropin RH; Early stage; Antihormone; Neoadjuvant treatment; Pelvic cavity; Male genital diseases; Non steroid compound; Human; Drug combination; Leuprorelin; Urinary system disease; Antiandrogen; Malignant tumor; Radiotherapy; Chemotherapy; Flutamide; Analog; Combined treatment; Goserelin; Prostate; Comparative study
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2003.05.004

This trial tested the hypothesis that combined androgen suppression (CAS) and whole-pelvic (WP) radiotherapy (RT) followed by a boost to the prostate improves progression-free survival (PFS) by 10% compared with CAS and prostate-only (PO) RT. This trial also tested the hypothesis that neoadjuvant and concurrent hormonal therapy (NCHT) improves PFS compared with adjuvant hormonal therapy (AHT) by 10%. Eligibility included localized prostate cancer with an elevated prostate-specific antigen (PSA) < or = 100 ng/mL and an estimated risk of lymph node (LN) involvement of 15%. Between April 1, 1995, and June 1, 1999, 1,323 patients were accrued. Patients were randomly assigned to WP + NCHT, PO + NCHT, WP + AHT, or PO + AHT. Failure for PFS was defined as the first occurrence of local, regional, or distant disease; PSA failure; or death for any cause. With a median follow-up of 59.5 months, WP RT was associated with a 4-year PFS of 54% compared with 47% in patients treated with PO RT (P =.022). Patients treated with NCHT experienced a 4-year PFS of 52% versus 49% for AHT (P =.56). When comparing all four arms, there was a progression-free difference among WP RT + NCHT, PO RT + NCHT, WP RT + AHT, and PO RT + AHT (60% v 44% v 49% v 50%, respectively; P =.008). No survival advantage has yet been seen. WP RT + NCHT improves PFS compared with PO RT and NCHT or PO RT and AHT, and compared with WP RT + AHT in patients with a risk of LN involvement of 15%.