Clinical results of combined treatment conformal high-dose-rate iridium-192 brachytherapy and external beam radiotherapy using staging lymphadenectomy for localized prostate cancer

PURPOSE: To report the first long-term biochemical control rate of patients treated with two protocols using a combination of external beam radiotherapy (EBRT) and high-dose-rate (HDR) brachytherapy for localized prostate cancer in Japan. METHODS AND MATERIALS: Between October 1997 and July 2001, 71 patients with localized prostatic adenocarcinoma were treated with a combination of EBRT and HDR brachytherapy. Patient age ranged from 58 to 81 years (mean 70.5). Of the 71 patients, 12, 41, and 18 had Stage T1c, T2, and T3, respectively, according to the International Union Against Cancer classification system (1997). The mean initial prostate-specific antigen (PSA) level was 24.2 ng/mL (median, 11.9 ng/mL); 30% of the patients had an initial PSA level >20 ng/mL. Of the 71 patients, 31 had received neoadjuvant hormonal therapy. Hormonal therapy before treatment was stopped at the beginning of RT in all cases. Patients in this series were treated on two protocols. In the initial protocol, patients were treated with whole pelvis EBRT to 45.0 Gy in 25 fractions and three HDR fractions of 5.5 Gy each (35 patients). In the second protocol, patients were treated with prostatic EBRT to 41.8 Gy in 19 fractions, with an added staging lymphadenectomy to rule out lymph node metastasis for patients with high-risk factors, and four HDR fractions of 5.5 Gy each (36 patients). The American Society for Therapeutic Radiology and Oncology consensus definition for biochemical failure was used. Acute and chronic toxicities were scored using the Radiation Therapy Oncology Group guidelines. Follow-up ranged from 24 to 65 months (median, 44 months). RESULTS: Of the 71 patients, 69 were alive at the last follow-up. Two patients had died of hepatocellular carcinoma and gastric cancer at 3.5 and 4.0 years after treatment with no biochemical failure. Sixty-six patients (93%), including the two who had died of intercurrent disease, showed a tendency for a PSA decline after treatment and had no biochemical or clinical evidence of disease at the last follow-up visit. Sixty patients (85%) achieved PSA nadir levels of < or =1.0 ng/mL. The biochemical/clinical failure-free control rate at 3 and at 5 years was 93% and 93%, respectively. The bladder and rectal complications were minimal. CONCLUSION: Despite the high frequency of high-risk patients in the present patient population, the actuarial biochemical control rate was 93% at 5 years. Acute and chronic toxicity with this method was acceptable. Additional long-term follow-up is required to assess this treatment, because the median survival is not likely to be reached for several years.