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

Research output: Contribution to journalArticle

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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

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Prostatic Neoplasms
Radiotherapy
Prostate-Specific Antigen
Neoplasm Grading
Quality of Life
Investigational Therapies
Enema
Terminology
Prostate

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. / Boike, Thomas P.; Lotan, Yair; Cho, L. Chinsoo; Brindle, Jeffrey; DeRose, Paul; Xie, Xian-Jin; Yan, Jingsheng; Foster, Ryan; Pistenmaa, David; Perkins, Alida; Cooley, Susan; Timmerman, Robert.

In: Journal of Clinical Oncology, Vol. 29, No. 15, 20.05.2011, p. 2020-2026.

Research output: Contribution to journalArticle

Boike, TP, Lotan, Y, Cho, LC, 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, vol. 29, no. 15, pp. 2020-2026. https://doi.org/10.1200/JCO.2010.31.4377
Boike, Thomas P. ; Lotan, Yair ; Cho, L. Chinsoo ; Brindle, Jeffrey ; DeRose, Paul ; Xie, Xian-Jin ; Yan, Jingsheng ; Foster, Ryan ; Pistenmaa, David ; Perkins, Alida ; Cooley, Susan ; Timmerman, Robert. / Phase I dose-escalation study of stereotactic body radiation therapy for low- and intermediate-risk prostate cancer. In: Journal of Clinical Oncology. 2011 ; Vol. 29, No. 15. pp. 2020-2026.
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AU - Brindle, Jeffrey

AU - DeRose, Paul

AU - Xie, Xian-Jin

AU - Yan, Jingsheng

AU - Foster, Ryan

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AU - Perkins, Alida

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