Stereotactic body radiation therapy for low and intermediate risk prostate cancer—Results from a multi-institutional clinical trial

• Published in: European journal of cancer (1990) Vol. 59; pp. 142 - 151
• Main Authors: Hannan, Raquibul, Tumati, Vasu, Xie, Xian-Jin, Cho, L. Chinsoo, Kavanagh, Brian D, Brindle, Jeffrey, Raben, David, Nanda, Akash, Cooley, Susan, Kim, D.W. Nathan, Pistenmaa, David, Lotan, Yair, Timmerman, Robert
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.05.2016
• Subjects: Aged; Aged, 80 and over; Analysis of Variance; Dose constraints; Hematology, Oncology and Palliative Medicine; Humans; Kaplan-Meier Estimate; Male; Neoplasm Grading; Prostate cancer; Prostate-Specific Antigen - metabolism; Prostatic Neoplasms - mortality; Prostatic Neoplasms - pathology; Prostatic Neoplasms - radiotherapy; Quality of Life; Radiosurgery - adverse effects; Radiosurgery - methods; Radiosurgery - mortality; Radiotherapy Dosage; SBRT; Stereotactic body radiation therapy; Treatment Outcome; Stereotactic body radiation therapy; Prostate cancer; Dose constraints; SBRT
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2016.02.014

Abstract Background We report the outcome of a phase I/II clinical trial of stereotactic body radiation therapy (SBRT) for low (LR) and select intermediate risk (IR) prostate cancer (PCa) patients. Patients and methods Eligible patients included men with prostate adenocarcinoma with Gleason score 6 with PSA ≤ 20 or Gleason 7 with PSA ≤ 15 and clinical stage ≤ T2b. For the phase I portion of the study patients in cohorts of 15 received 45, 47.5, or 50 Gray (Gy) in five fractions. Since the maximally tolerated dose was not met in the phase I study, an additional 47 patients received 50 Gy in five fractions in the phase II study. Toxicity using Common Toxicity Criteria for Adverse Events v. 3.0, quality of life, and outcome data was collected. Results A total of 91 patients are included for analysis; 63.7% had NCCN IR and 36.3% had LR PCa. At a median follow up of 54 months the actuarial freedom from biochemical failure was 100% at 3 years and 98.6% at 5 years. Actuarial distant metastasis free survival was 100% at 3 and 5 years. Overall survival was 94% at 3 years and 89.7% at 5 years with no deaths attributed to PCa. Acute and late urinary grade ≥ III toxicity occurred in 0% and 5.5% of patients, respectively. Gastrointestinal (GI) acute and late toxicity of grade ≥ III occurred in 2% and 7% of patients, respectively. A total of four men experienced grade IV toxicity (three GI, one genitourinary). Conclusion SBRT treatment results in excellent biochemical control rates at 5 years for LR and IR PCa patients although doses greater than 47.5 Gy in five fractions led to increased severe late toxicity.