Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer

Thomas P. Boike, Yair Lotan, L. Chinsoo Cho, Jeffrey Brindle, Paul DeRose, Xian-Jin Xie, Jingsheng Yan, Ryan Foster, David Pistenmaa, Alida Perkins, Susan Cooley, Robert Timmerman

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161 Scopus citations

Abstract

Purpose: To evaluate the tolerability of escalating doses of stereotactic body radiation therapy in the treatment of localized prostate cancer. Patients and Methods: Eligible patients included those with Gleason score 2 to 6 with prostate-specific antigen (PSA) ≤ 20, Gleason score 7 with PSA ≤ 15, ≤ T2b, prostate size ≤ 60 cm3, and American Urological Association (AUA) score ≤ 15. Pretreatment preparation required an enema and placement of a rectal balloon. Dose-limiting toxicity (DLT) was defined as grade 3 or worse GI/genitourinary (GU) toxicity by Common Terminology Criteria of Adverse Events (version 3). Patients completed quality-of-life questionnaires at defined intervals. Results: Groups of 15 patients received 45 Gy, 47.5 Gy, and 50 Gy in five fractions (45 total patients). The median follow-up is 30 months (range, 3 to 36 months), 18 months (range, 0 to 30 months), and 12 months (range, 3 to 18 months) for the 45 Gy, 47.5 Gy, and 50 Gy groups, respectively. For all patients, GI grade ≥ 2 and grade ≥ 3 toxicity occurred in 18% and 2%, respectively, and GU grade ≥ 2 and grade ≥ 3 toxicity occurred in 31% and 4%, respectively. Mean AUA scores increased significantly from baseline in the 47.5-Gy dose level (P = .002) as compared with the other dose levels, where mean values returned to baseline. Rectal quality-of-life scores (Expanded Prostate Cancer Index Composite) fell from baseline up to 12 months but trended back at 18 months. In all patients, PSA control is 100% by the nadir + 2 ng/mL failure definition. Conclusion: Dose escalation to 50 Gy has been completed without DLT. A multicenter phase II trial is underway treating patients to 50 Gy in five fractions to further evaluate this experimental therapy.

Original languageEnglish (US)
Pages (from-to)2020-2026
Number of pages7
JournalJournal of Clinical Oncology
Volume29
Issue number15
DOIs
StatePublished - May 20 2011

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Boike, T. P., Lotan, Y., Cho, L. C., Brindle, J., DeRose, P., Xie, X-J., Yan, J., Foster, R., Pistenmaa, D., Perkins, A., Cooley, S., & Timmerman, R. (2011). Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. Journal of Clinical Oncology, 29(15), 2020-2026. https://doi.org/10.1200/JCO.2010.31.4377