A Phase II Trial of Stereotactic Ablative Body Radiotherapy for Low-Risk Prostate Cancer Using a Non-Robotic Linear Accelerator and Real-Time Target Tracking: Report of Toxicity, Quality of Life, and Disease Control Outcomes with 5-Year Minimum Follow-Up.

Constantine Mantz

doi:10.3389/fonc.2014.00279

Abstract

Purpose/Objective(s): Herein, we report the results of an IRB-approved phase II trial of Varian Trilogy/TrueBeam-based stereotactic ablative body radiotherapy (SABR) monotherapy for low-risk prostate cancer using the Calypso® System to provide real-time electromagnetic tracking of the prostate’s position during treatment delivery.Materials/Methods: A total of 102 low-risk patients completed protocol treatment between January 2007 and May 2009. A total dose of 40.0 Gy in 5 every-other-day fractions of 8.0 Gy was prescribed to the planning target volume. Target setup and tracking procedures were as follows: (1) the Calypso® System was used to achieve target setup prior to each fraction; (2) conebeam CT imaging was then used for correction of setup error and for assessment of target and organs-at-risk deformations; (3) after treatment delivery was initiated, the Calypso® System then provided real-time intrafractional target tracking. The NCI CTCAE v3.0 was used to assess urinary and rectal toxicity during treatment and at defined follow-up time points. Biochemical response and quality of life measurements were made at concurrent follow-up points.Results: Urinary toxicities were most common. At 6 months, 19.6, 2.9, and 4.9% of patients reported grades 1–2 urinary frequency, dysuria, and retention, respectively. Rectal toxicities were uncommon. By 12 months, 2.9% of patients reported painless rectal bleeding with subsequent symptom resolution without requiring invasive interventions. Quality of life measurements demonstrated a significant decline over baseline in urinary irritative/obstructive scores at 1 month following SABR but otherwise did not demonstrate any difference for bowel, bladder, and sexual function scores at any other follow-up time point. One patient suffered biochemical recurrence at 6 years following SABR.Conclusion: At 5 years, minimum follow-up for this favorable patient cohort, prostate SABR resulted in favorable toxicity, quality of life, and biochemical outcomes.

Highlights

Stereotactic ablative body radiotherapy (SABR) is a recent external beam radiation treatment modality in the curative management of localized prostate cancer
Quality of life measurements demonstrated a significant decline over baseline in urinary irritative/obstructive scores at 1 month following SABR but otherwise did not demonstrate any difference for bowel, bladder, and sexual function scores at any other follow-up time point
At 5 years, minimum follow-up for this favorable patient cohort, prostate SABR resulted in favorable toxicity, quality of life, and biochemical outcomes

Summary

Introduction

Stereotactic ablative body radiotherapy (SABR) is a recent external beam radiation treatment modality in the curative management of localized prostate cancer. Dose–response analyses of disease outcomes have generally concluded that the α:β ratio for prostate cancer may be exceptionally low, with studies reporting estimated ratios as low as 1.5 [2,3,4,5,6,7,8,9] Caveats to this conclusion of a low α:β ratio for prostate cancer include [1] the mathematical assumptions made in some studies in order to allow for comparisons between external beam radiotherapy and brachytherapy outcomes and [2] the lack of certainty that the linear-quadratic model may be applied to estimating dose–response when very large fractional doses are considered [10,11,12].

Methods

Results

Conclusion