Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: first clinical trial results.

PURPOSE: To evaluate the feasibility and toxicity of stereotactic hypofractionated accurate radiotherapy (SHARP) for localized prostate cancer. METHODS AND MATERIALS: A Phase I/II trial of SHARP performed for localized prostate cancer using 33.5 Gy in 5 fractions, calculated to be biologically equivalent to 78 Gy in 2 Gy fractions (alpha/beta ratio of 1.5 Gy). Noncoplanar conformal fields and daily stereotactic localization of implanted fiducials were used for treatment. Genitourinary (GU) and gastrointestinal (GI) toxicity were evaluated by American Urologic Association (AUA) score and Common Toxicity Criteria (CTC). Prostate-specific antigen (PSA) values and self-reported sexual function were recorded at specified follow-up intervals. RESULTS: The study includes 40 patients. The median follow-up is 41 months (range, 21-60 months). Acute toxicity Grade 1-2 was 48.5% (GU) and 39% (GI); 1 acute Grade 3 GU toxicity. Late Grade 1-2 toxicity was 45% (GU) and 37% (GI). No late Grade 3 or higher toxicity was reported. Twenty-six patients reported potency before therapy; 6 (23%) have developed impotence. Median time to PSA nadir was 18 months with the majority of nadirs less than 1.0 ng/mL. The actuarial 48-month biochemical freedom from relapse is 70% for the American Society for Therapeutic Radiology and Oncology definition and 90% by the alternative nadir + 2 ng/mL failure definition. CONCLUSIONS: SHARP for localized prostate cancer is feasible with minimal acute or late toxicity. Dose escalation should be possible.

Intrafractional stability of the prostate using a stereotactic radiotherapy technique.

PURPOSE: To evaluate the stability of the prostate during stereotactic radiation therapy. MATERIALS AND METHODS: Forty-seven patients underwent placement of three fiducial markers into the prostate as part of a pilot study of hypofractionated stereotactic radiotherapy. Portal images before and subsequent to 227 radiotherapy fractions were analyzed for prostate movement. Six patients also underwent localizing radiographs at 6-min intervals for 24 min. Relative motion of the bony landmarks and prostate markers was calculated. RESULTS: Analysis of portal images revealed the undirected average prostate movement of 2.0 mm (superior/inferior), 1.9 mm (anterior/posterior), and 1.4 mm (right/left) with maximum standard deviation (SD) of 2.0. Analysis of radiographs at 6-min intervals showed the greatest undirected average prostate motion between 0-6 min; 1.5 mm (superior/inferior), 1.4 mm (anterior/posterior), and 0.4 mm (right/left). Beyond 6 min, movements decreased to 0.4, 0.9, and 0.8 mm, respectively. Bony landmark motion was 0.9 mm (superior/inferior), 0.9 mm (anterior/posterior), and 0.4 mm (right/left) between 0-6 min. Beyond 6 min, motion decreased to less than 0.5 mm in any direction. CONCLUSIONS: Stereotactic prostate radiotherapy, utilizing fiducial marker localization, resulted in average intrafractional prostate movement of 2.0 mm or less. Most patient and organ movement occurs early and a settling-in period is advisable before treatment.