A Phase II Trial of Stereotactic Ablative Body Radiotherapy

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.
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.
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.
At 5 years, minimum follow-up for this favorable patient cohort, prostate SABR resulted in favorable toxicity, quality of life, and biochemical outcomes.