A Phase I/II Trial of Fairly Brief Androgen Suppression and Stereotactic Radiation Therapy for High-Risk Prostate Cancer (FASTR-2): Preliminary Results and Toxicity Analysis.

FASTR was designed to provide a compact treatment course for high-risk prostate cancer patients but was discontinued because of excess toxicity. We present the results of FASTR-2, which used a lower dose to the prostate (35 Gy vs 40 Gy), smaller posterior PTV margin (4 mm vs 5 mm) and omitted nodal radiation to lower the volumes of rectum receiving high and intermediate doses compared with FASTR. Gastrointestinal (GI) and genitourinary (GU) toxicities at baseline, 6 weeks, 6 months, and 1 year and biochemical control rates are presented. Eligibility included high-risk prostate cancer (cT3/4, prostate-specific antigen >20 or Gleason Score ≥8), age ≥70 or refused standard treatment, and no evidence of metastatic disease. Patients received 18 months of androgen deprivation therapy starting 2 months before radiation. Clinical target volume was defined as prostate plus proximal 1-cm seminal vesicles. PTV was a nonuniform expansion around clinical target volume (4 mm posteriorly, 5 mm in all other directions). Volumetric arc therapy was used for treatment delivery (35 Gy delivered in 5 weekly fractions of 7 Gy each), and cone beam computed tomography with soft tissue matching (no fiducial placement) was used for daily image guidance. Toxicity was assessed at 6 weeks, 6 months, and 1 year according to Common Toxicity Criteria. In the study, 30 patients were enrolled in FASTR-2 between 2015 and 2017. Two patients were withdrawn owing to ineligibility after enrollment. One patient (3.7%) reported grade 2 GI toxicity at 6 weeks. There was no reported grade ≥2 GI toxicity at 6 months or 1 year. There were no reported episodes of rectal bleeding. Four patients (14.8%), 5 patients (17.9%), and 5 patients (21.7%) reported grade 2 GU toxicity at 6 weeks, 6 months, and 1 year, respectively. There were no reported cases of grade ≥3 GU toxicity. The most common toxicities were nocturia and urinary frequency or urgency. FASTR-2 was more tolerable than FASTR, with no grade ≥3 toxicities reported, in keeping with expectations based on our previous FASTR analysis. Long-term follow-up is necessary to ensure disease control and toxicity outcomes are comparable to conventional high-risk treatment paradigms.

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