Long-Term Results of a Prospective, Phase II Study of Long-Term Androgen Ablation, Pelvic Radiotherapy, Brachytherapy Boost, and Adjuvant Docetaxel in Patients With High-Risk Prostate Cancer

• Published in: International journal of radiation oncology, biology, physics Vol. 81; no. 3; pp. 732 - 736
• Main Authors: DiBiase, Steven J., M.D, Hussain, Arif, M.D, Kataria, Ritesh, Amin, Pradip, M.D, Bassi, Sunakshi, Dawson, Nancy, M.D, Kwok, Young, M.D
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01-11-2011; Elsevier
• Subjects: ABLATION; Adenocarcinoma - blood; Adenocarcinoma - drug therapy; Adenocarcinoma - pathology; Adenocarcinoma - radiotherapy; Adjuvant docetaxel; Aged; Androgen Antagonists - therapeutic use; ANDROGENS; ANDROSTANES; ANTIGENS; Antineoplastic agents; Antineoplastic Agents - administration & dosage; BETA DECAY RADIOISOTOPES; Biological and medical sciences; BIOPSY; BODY; BRACHYTHERAPY; Brachytherapy - adverse effects; Brachytherapy - methods; CARCINOMAS; CHEMOTHERAPY; Chemotherapy, Adjuvant - methods; DAYS LIVING RADIOISOTOPES; DIAGNOSTIC TECHNIQUES; Disease-Free Survival; DISEASES; ELECTRON CAPTURE RADIOISOTOPES; EVEN-ODD NUCLEI; FAILURES; GLANDS; Gynecology. Andrology. Obstetrics; HAZARDS; Hematology, Oncology and Palliative Medicine; HORMONES; Humans; INTERMEDIATE MASS NUCLEI; INTERNAL CONVERSION RADIOISOTOPES; IODINE 125; IODINE ISOTOPES; ISOTOPES; Male; Male genital diseases; MALE GENITALS; Medical sciences; MEDICINE; Middle Aged; Multimodality; Neoplasm Grading; Neoplasm Staging; NEOPLASMS; Nephrology. Urinary tract diseases; NUCLEAR MEDICINE; NUCLEI; ODD-EVEN NUCLEI; ORGANIC COMPOUNDS; ORGANS; PALLADIUM 103; PALLADIUM ISOTOPES; Pelvis; Pharmacology. Drug treatments; Prospective Studies; PROSTATE; Prostate cancer; Prostate-Specific Antigen - blood; Prostatic Neoplasms - blood; Prostatic Neoplasms - drug therapy; Prostatic Neoplasms - pathology; Prostatic Neoplasms - radiotherapy; RADIOISOTOPES; RADIOLOGY; RADIOLOGY AND NUCLEAR MEDICINE; RADIOTHERAPY; Radiotherapy - adverse effects; Radiotherapy - methods; STEROID HORMONES; STEROIDS; Taxoids - administration & dosage; THERAPY; TOXICITY; Tumors; Tumors of the urinary system; Urinary tract. Prostate gland; Brachytherapy; Adjuvant docetaxel; Radiotherapy; Multimodality; Prostate cancer; Antineoplastic agent; Human; Urinary system disease; Androgen deprivation therapy; Prostate disease; Docetaxel; Malignant tumor; Taxane derivatives; Risk factor; Antimitotic; Male genital diseases; Curietherapy; Cancer
• ISSN: 0360-3016; 1879-355X
• DOI: 10.1016/j.ijrobp.2010.06.042

Purpose We report the long-term results of a prospective, Phase II study of long-term androgen deprivation (AD), pelvic radiotherapy (EBRT), permanent transperineal prostate brachytherapy boost (PB), and adjuvant docetaxel in patients with high-risk prostate cancer. Methods and Materials Eligibility included biopsy-proven prostate adenocarcinoma with the following: prostate-specific antigen (PSA) > 20 ng/ml; or Gleason score of 7 and a PSA >10 ng/ml; or any Gleason score of 8 to 10; or stage T2b to T3 irrespective of Gleason score or PSA. Treatment consisted of 45 Gy of pelvic EBRT, followed 1 month later by PB with either iodine-125 or Pd-103. One month after PB, patients received three cycles of docetaxel chemotherapy (35 mg/m2 per week, Days 1, 8, and 15 every 28 days). All patients received 2 years of AD. Biochemical failure was defined as per the Phoenix definition (PSA nadir + 2). Results From August 2000 to March 2004, 42 patients were enrolled. The median overall and active follow-ups were 5.6 years (range, 0.9–7.8 years) and 6.3 years (range, 4–7.8 years), respectively. Grade 2 and 3 acute genitourinary (GU) and gastrointestinal (GI) toxicities were 50.0% and 14.2%, respectively, with no Grade 4 toxicities noted. Grade 3 and 4 acute hematologic toxicities were 19% and 2.4%, respectively. Of the patients, 85.7% were able to complete the planned multimodality treatment. The 5- and 7-year actuarial freedom from biochemical failures rates were 89.6% and 86.5%, and corresponding rates for disease-free survival were 76.2% and 70.4%, respectively. The 5- and 7-year actuarial overall survival rates were 83.3% and 80.1%, respectively. The 5- and 7-year actuarial rates of late Grade 2 GI/GU toxicity (no Grade 3–5) was 7.7%. Conclusions The trimodality approach of using 2 years of AD, external radiation, brachytherapy, and upfront docetaxel in high-risk prostate cancer is well tolerated, produces encouraging long-term results, and should be validated in a multi-institutional setting.