A phase IB clinical trial of 15 Gy HDR brachytherapy followed by hypofractionated/SBRT in the management of intermediate-risk prostate cancer

• Published in: Brachytherapy Vol. 19; no. 3; pp. 282 - 289
• Main Authors: Den, Robert B., Greenspan, Jacob, Doyle, Laura A., Harrison, Amy S., Peng, Cheng, Williams, Noelle L., Lallas, Costas D., Trabulsi, Edouard J., Gomella, Leonard G., Hurwitz, Mark D., Leiby, Benjamin, Dicker, Adam P.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2020
• Subjects: Aged; Aged, 80 and over; Brachytherapy - adverse effects; Brachytherapy - methods; Clinical trial; Disease-Free Survival; EPIC; Follow-Up Studies; HDR brachytherapy; Humans; Hypofractionation; Intestinal Diseases - etiology; Male; Middle Aged; Prospective Studies; Prostate cancer; Prostate-Specific Antigen - blood; Prostatic Neoplasms - blood; Prostatic Neoplasms - radiotherapy; Quality of Life; Radiation Dose Hypofractionation; Radiation Injuries - etiology; Radiosurgery - adverse effects; Radiosurgery - methods; SBRT; Sexual Dysfunction, Physiological - etiology; Urologic Diseases - etiology; Hypofractionation; Clinical trial; EPIC; Prostate cancer; SBRT; HDR brachytherapy
• ISSN: 1538-4721; 1873-1449
• DOI: 10.1016/j.brachy.2020.02.008

High dose-rate (HDR) brachytherapy is commonly administered as a boost to external beam radiation therapy (EBRT). Our purpose was to compare toxicity with increasingly hypofractionated EBRT in combination with a single 15 Gy HDR boost for men with intermediate-risk prostate cancer. Forty-two men were enrolled on this phase IB clinical trial to one of three EBRT dose cohorts: 10 fractions, seven fractions, or five fractions. Patients were followed prospectively for safety, efficacy, and health-related quality of life (Expanded Prostate Index Composite). Efficacy was assessed biochemically using the Phoenix definition. With a median follow up of 36 months, the biochemical disease-free survival was 95.5%. One man developed metastatic disease at 5 years. There was no significant minimally important difference in EPIC PRO for either urinary, bowel, or sexual domains. There was one acute Grade 3 GI and GU toxicity, but no late Grade 3 GU or GI toxicities. Fifteen gray HDR brachytherapy followed by a five fraction SBRT approach results in high disease control rates and low toxicity similar to previously reported HDR protocols with significant improvement in patient convenience and resource savings. While mature results with longer follow up are awaited, this treatment approach may be considered a safe and effective option for men with intermediate-risk disease.