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Original article
peer-reviewed

Stereotactic Body Radiotherapy for Clinically Localized Prostate Cancer: Toxicity and Biochemical Disease-Free Outcomes from a Multi-Institutional Patient Registry



Abstract

Objectives: To report on initial patient characteristics, treatment practices, toxicity, and early biochemical disease-free survival (bDFS) of localized prostate cancer treated with stereotactic body radiotherapy (SBRT) and enrolled in the RSSearch® Patient Registry.

Methods: A retrospective analysis was conducted on patients with clinically localized prostate cancer enrolled in RSSearch® from June 2006 - January 2015. Patients were classified as low-risk (PSA ≤ 10 ng/ml, T1c-T2a, Gleason score ≤ 6), intermediate-risk (PSA 10.1 - 20 ng/ml, T2b-T2c, or Gleason 7), or high-risk (PSA > 20 ng/ml, T3 or Gleason ≥ 8). Toxicity was reported using Common Toxicity Criteria for Adverse Events, version 3. Biochemical failure was assessed using the Phoenix definition (nadir + 2 ng/ml). The Kaplan-Meier analysis was used to calculate bDFS and association of patient and tumor characteristics with the use of SBRT.

Results: Four hundred thirty-seven patients (189 low, 215 intermediate, and 33 high-risk) at a median of 69 years (range: 48-88) received SBRT at 17 centers. Seventy-eight percent of patients received 36.25 Gy/5 fractions, 13% received 37 Gy/5 fractions, 6% received 35 Gy/5 fractions, 3% received 38 Gy/4 fractions, and 5% received a boost dose of 19.5-29 Gy following external beam radiation therapy. Median follow-up was 20 months (range: 1–64 months). Genitourinary (GU) and gastrointestinal (GI) toxicities were minimal, with no acute or late Grade 3+ GU or GI toxicity. Late Grade 1 and 2 urinary frequency was 25% and 8%. Late Grade 1 and 2 proctitis was 3% and 2%. Median PSA decreased from 5.8 ng/ml (range: 0.3-43) to 0.88, 0.4, and 0.3 ng/ml at one, two, and three years. Two-year bDFS for all patients was 96.1%. Two-year bDFS was 99.0%, 94.5%, and 89.8% for low, intermediate, and high-risk patients (p < 0.0001). Two-year bDFS was 99.2%, 93.2%, and 90.4% for Gleason ≤ 6, Gleason 7, and Gleason ≥ 8 (p < 0.0001). Two-year bDFS was 96.4%, 97.2%, and 62.5% for PSA ≤ 10 ng/ml, PSA 10.1 - 20 ng/ml, and PSA > 20 ng/ml (p < 0.0001). Clinical T Stage was not significantly associated with bDFS. 

Conclusions: Early disease outcomes of SBRT for the treatment of clinically localized prostate cancer from a multicenter patient registry compare favorably with reports from single institutions. Acute and late GU and GI toxicities were minimal, and PSA response to SBRT was highly encouraging. Continued accrual and follow-up will be necessary to confirm long-term results.



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Original article
peer-reviewed

Stereotactic Body Radiotherapy for Clinically Localized Prostate Cancer: Toxicity and Biochemical Disease-Free Outcomes from a Multi-Institutional Patient Registry


Author Information

Joanne Davis Corresponding Author

Executive Director, The Radiosurgery Society

Sanjeev Sharma

Department of Radiation Oncology, St. Mary's Medical Center

Richard Shumway

Department of Radiation Oncology, Saint Francis Hospital and Medical Center

David Perry

Radiation Oncology, Medstar Franklin Square Medical Center, Baltimore, MD

Sean Bydder

Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia

C. Kelley Simpson

Radiation Oncology, Colorado CyberKnife, Lafayette, CO

David D'Ambrosio

Radiation Oncology, Community Medical Center-Barnabas Health

NJ Cyberknife, Community Medical Center-Barnabas Health


Ethics Statement and Conflict of Interest Disclosures

Human subjects: Consent was obtained by all participants in this study. Community Medical Center, Barnabas Health issued approval 11-018. Animal subjects: This study did not involve animal subjects or tissue. Conflicts of interest: The authors have declared the following conflicts of interest: Financial relationships: C. Kelley Simpson declare(s) Co-ownership of Colorado CyberKnife from Colorado CyberKnife.

Acknowledgements

We would like to thank the patients, physicians and healthcare staff who participated in the RSSearch® Patient Registry and acknowledge the following RSSearch® Registry centers: Bristol Regional Medical Center, Bristol, TN; Community Medical Center/Barnabas Health, Toms River, NJ; Colorado CyberKnife, Lafayette, CO; CyberKnife Center of Saint Francis Hospital, Hartford, CT; Erlanger Health System, Chattanooga, TN; Eastern Texas Medical Center, Tyler, TX; Medstar Franklin Square Medical Center, Baltimore, MD; HealthEast/St. Joseph’s Hospital, St. Paul, MN; Pennsylvania University Hospital, Philadelphia, PA; Rothman Specialty Hospital, Bensalem, PA; St. John’s Radiosurgery Center, Springfield, MO; St. Joseph’s/Candler Hospital, Savannah, GA; Saint Francis Hospital, Memphis, TN; Saint Mary’s Medical Center, Huntington, WV; Saint Peter's University Hospital, New Brunswick, NJ; Sir Charles Gairdner Hospital, Perth, Australia; Southeast Georgia Health System, Brunswick, GA.


Original article
peer-reviewed

Stereotactic Body Radiotherapy for Clinically Localized Prostate Cancer: Toxicity and Biochemical Disease-Free Outcomes from a Multi-Institutional Patient Registry


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Original article
peer-reviewed

Stereotactic Body Radiotherapy for Clinically Localized Prostate Cancer: Toxicity and Biochemical Disease-Free Outcomes from a Multi-Institutional Patient Registry

  • Author Information
    Joanne Davis Corresponding Author

    Executive Director, The Radiosurgery Society

    Sanjeev Sharma

    Department of Radiation Oncology, St. Mary's Medical Center

    Richard Shumway

    Department of Radiation Oncology, Saint Francis Hospital and Medical Center

    David Perry

    Radiation Oncology, Medstar Franklin Square Medical Center, Baltimore, MD

    Sean Bydder

    Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia

    C. Kelley Simpson

    Radiation Oncology, Colorado CyberKnife, Lafayette, CO

    David D'Ambrosio

    Radiation Oncology, Community Medical Center-Barnabas Health

    NJ Cyberknife, Community Medical Center-Barnabas Health


    Ethics Statement and Conflict of Interest Disclosures

    Human subjects: Consent was obtained by all participants in this study. Community Medical Center, Barnabas Health issued approval 11-018. Animal subjects: This study did not involve animal subjects or tissue. Conflicts of interest: The authors have declared the following conflicts of interest: Financial relationships: C. Kelley Simpson declare(s) Co-ownership of Colorado CyberKnife from Colorado CyberKnife.

    Acknowledgements

    We would like to thank the patients, physicians and healthcare staff who participated in the RSSearch® Patient Registry and acknowledge the following RSSearch® Registry centers: Bristol Regional Medical Center, Bristol, TN; Community Medical Center/Barnabas Health, Toms River, NJ; Colorado CyberKnife, Lafayette, CO; CyberKnife Center of Saint Francis Hospital, Hartford, CT; Erlanger Health System, Chattanooga, TN; Eastern Texas Medical Center, Tyler, TX; Medstar Franklin Square Medical Center, Baltimore, MD; HealthEast/St. Joseph’s Hospital, St. Paul, MN; Pennsylvania University Hospital, Philadelphia, PA; Rothman Specialty Hospital, Bensalem, PA; St. John’s Radiosurgery Center, Springfield, MO; St. Joseph’s/Candler Hospital, Savannah, GA; Saint Francis Hospital, Memphis, TN; Saint Mary’s Medical Center, Huntington, WV; Saint Peter's University Hospital, New Brunswick, NJ; Sir Charles Gairdner Hospital, Perth, Australia; Southeast Georgia Health System, Brunswick, GA.


    Article Information

    Published: December 04, 2015

    DOI

    10.7759/cureus.395

    Cite this article as:

    Davis J, Sharma S, Shumway R, et al. (December 04, 2015) Stereotactic Body Radiotherapy for Clinically Localized Prostate Cancer: Toxicity and Biochemical Disease-Free Outcomes from a Multi-Institutional Patient Registry. Cureus 7(12): e395. doi:10.7759/cureus.395

    Publication history

    Received by Cureus: October 29, 2015
    Peer review began: November 03, 2015
    Peer review concluded: December 01, 2015
    Published: December 04, 2015

    Copyright

    © Copyright 2015
    Davis et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 3.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

    License

    This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Objectives: To report on initial patient characteristics, treatment practices, toxicity, and early biochemical disease-free survival (bDFS) of localized prostate cancer treated with stereotactic body radiotherapy (SBRT) and enrolled in the RSSearch® Patient Registry.

Methods: A retrospective analysis was conducted on patients with clinically localized prostate cancer enrolled in RSSearch® from June 2006 - January 2015. Patients were classified as low-risk (PSA ≤ 10 ng/ml, T1c-T2a, Gleason score ≤ 6), intermediate-risk (PSA 10.1 - 20 ng/ml, T2b-T2c, or Gleason 7), or high-risk (PSA > 20 ng/ml, T3 or Gleason ≥ 8). Toxicity was reported using Common Toxicity Criteria for Adverse Events, version 3. Biochemical failure was assessed using the Phoenix definition (nadir + 2 ng/ml). The Kaplan-Meier analysis was used to calculate bDFS and association of patient and tumor characteristics with the use of SBRT.

Results: Four hundred thirty-seven patients (189 low, 215 intermediate, and 33 high-risk) at a median of 69 years (range: 48-88) received SBRT at 17 centers. Seventy-eight percent of patients received 36.25 Gy/5 fractions, 13% received 37 Gy/5 fractions, 6% received 35 Gy/5 fractions, 3% received 38 Gy/4 fractions, and 5% received a boost dose of 19.5-29 Gy following external beam radiation therapy. Median follow-up was 20 months (range: 1–64 months). Genitourinary (GU) and gastrointestinal (GI) toxicities were minimal, with no acute or late Grade 3+ GU or GI toxicity. Late Grade 1 and 2 urinary frequency was 25% and 8%. Late Grade 1 and 2 proctitis was 3% and 2%. Median PSA decreased from 5.8 ng/ml (range: 0.3-43) to 0.88, 0.4, and 0.3 ng/ml at one, two, and three years. Two-year bDFS for all patients was 96.1%. Two-year bDFS was 99.0%, 94.5%, and 89.8% for low, intermediate, and high-risk patients (p < 0.0001). Two-year bDFS was 99.2%, 93.2%, and 90.4% for Gleason ≤ 6, Gleason 7, and Gleason ≥ 8 (p < 0.0001). Two-year bDFS was 96.4%, 97.2%, and 62.5% for PSA ≤ 10 ng/ml, PSA 10.1 - 20 ng/ml, and PSA > 20 ng/ml (p < 0.0001). Clinical T Stage was not significantly associated with bDFS. 

Conclusions: Early disease outcomes of SBRT for the treatment of clinically localized prostate cancer from a multicenter patient registry compare favorably with reports from single institutions. Acute and late GU and GI toxicities were minimal, and PSA response to SBRT was highly encouraging. Continued accrual and follow-up will be necessary to confirm long-term results.



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Joanne Davis, Ph.D.

Executive Director, The Radiosurgery Society

For correspondence:
jdavis@therss.org

Sanjeev Sharma

Department of Radiation Oncology, St. Mary's Medical Center

Richard Shumway

Department of Radiation Oncology, Saint Francis Hospital and Medical Center

David Perry, M.D.

Radiation Oncology, Medstar Franklin Square Medical Center, Baltimore, MD

Sean Bydder

Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia

C. Kelley Simpson

Radiation Oncology, Colorado CyberKnife, Lafayette, CO

David D'Ambrosio, M.D.

Radiation Oncology, Community Medical Center-Barnabas Health

Joanne Davis, Ph.D.

Executive Director, The Radiosurgery Society

For correspondence:
jdavis@therss.org

Sanjeev Sharma

Department of Radiation Oncology, St. Mary's Medical Center

Richard Shumway

Department of Radiation Oncology, Saint Francis Hospital and Medical Center

David Perry, M.D.

Radiation Oncology, Medstar Franklin Square Medical Center, Baltimore, MD

Sean Bydder

Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Australia

C. Kelley Simpson

Radiation Oncology, Colorado CyberKnife, Lafayette, CO

David D'Ambrosio, M.D.

Radiation Oncology, Community Medical Center-Barnabas Health