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Clinical Research

RTOG 0518: randomized phase III trial to evaluate zoledronic acid for prevention of osteoporosis and associated fractures in prostate cancer patients

Prostate Cancer and Prostatic Diseases volume 16, pages 382–386 (2013)Cite this article

Subjects

Abstract

Background:

RTOG 0518 evaluated the potential benefit of zoledronic acid therapy in preventing bone fractures for patients with high grade and/or locally advanced, non-metastatic prostate adenocarcinoma receiving luteinizing hormone-releasing hormone (LHRH) agonist and radiotherapy (RT).

Methods:

Eligible patients with T-scores of the hip (<−1.0, but >−2.5 vs >−1.0) and negative bone scans were prospectively randomized to either zoledronic acid, 4 mg, concurrently with the start of RT and then every six months for a total of 6 infusions (Arm 1) or observation (Arm 2). Vitamin D and calcium supplements were given to all patients. Secondary objectives included quality of life (QOL) and bone mineral density (BMD) changes over a period of three years.

Results:

Of 109 patients accrued before early closure, 96 were eligible. Median follow-up was 36.3 months for Arm 1 and 34.8 months for Arm 2. Only two patients experienced a bone fracture (one in each arm) resulting in no difference in freedom from any bone fracture (P=0.95), nor in QOL. BMD percent changes from baseline to 36 months were statistically improved with the use of zoledronic acid compared to observation for the lumbar spine (6% vs −5%, P<0.0001), left total hip (1% vs −8%, P=0.0002), and left femoral neck (3% vs −8%, P=0.0007).

Conclusions:

For patients with advanced, non-metastatic prostate cancer receiving LHRH agonist and RT, the use of zoledronic acid was associated with statistically improved BMD percent changes. The small number of accrued patients resulted in decreased statistical power to detect any differences in the incidence of bone fractures or QOL.

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Acknowledgements

This trial was conducted by the Radiation Therapy Oncology Group (RTOG), and was supported by RTOG grant U10 CA21661 and CCOP grant U10 CA37422 from the National Cancer Institute. This manuscript’s contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute. Zometa was manufactured and packaged by Novartis and provided to patients on study.

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Authors and Affiliations

  1. Department of Radiation Oncology, Boston University Medical Center, Boston, MA, USA

    L A Kachnic

  2. Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA, USA

    S L Pugh

  3. University of Saskatchewan, Regina, Sasktachewan, Canada

    P Tai & C A F Lawton

  4. Harvard Medical School, Boston, MA, USA

    M Smith

  5. Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI, USA

    E Gore & C A F Lawton

  6. York Cancer Center, York, PA, USA

    A B Shah

  7. Laval University, Quebec City, QC, Canada

    A-G Martin

  8. Wayne State University Medical School, Detroit, MI, USA

    H E Kim

  9. Department of Radiation Oncology, Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada

    A Nabid

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  1. L A Kachnic
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Correspondence to L A Kachnic.

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Kachnic, L., Pugh, S., Tai, P. et al. RTOG 0518: randomized phase III trial to evaluate zoledronic acid for prevention of osteoporosis and associated fractures in prostate cancer patients. Prostate Cancer Prostatic Dis 16, 382–386 (2013). https://doi.org/10.1038/pcan.2013.35

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