Highlights
- •Results of a multi-institutional study of stereotactic body radiation therapy for prostate cancer are reported.
- •Doses up to 47.5 Gy in five fractions resulted in high control with acceptable toxicity.
- •Fifty gray in five fractions was associated with an increase in late high grade toxicity.
- •Three and five year biochemical control rates are 100 and 98.6% respectively.
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.
Keywords
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Article Info
Publication History
Published online: March 29, 2016
Accepted:
February 13,
2016
Received in revised form:
January 28,
2016
Received:
November 19,
2015
Footnotes
☆Supported by a Clinical Trial Award from the US Department of Defense (grant no. PC061629 ; R.T., principal investigator). Registered at Clinicaltrials.gov study number NCT00547339.
Identification
Copyright
© 2016 Elsevier Ltd. All rights reserved.
