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Clinical Research

Impact of NADiA ProsVue PSA slope on secondary treatment decisions after radical prostatectomy

Prostate Cancer and Prostatic Diseases volume 17, pages 280–285 (2014)Cite this article

Subjects

Abstract

BACKGROUND:

Selecting appropriate candidates for postprostatectomy radiotherapy is challenging, because adverse pathological features cannot accurately predict clinical recurrence. Biomarkers that identify residual disease activity may assist clinicians when counseling patients on the risks, benefits and costs of secondary treatment. NADiA ProsVue PSA slope results ⩽2.0 pg ml−1 month−1 are predictive of a reduced risk of clinical recurrence; however, its clinical utility has not yet been studied.

METHODS:

We prospectively enrolled men treated by radical prostatectomy in a multicenter, institutional review board-approved clinical trial. At postsurgical follow-up, investigators (N=17) stratified men into low-, intermediate- or high-risk groups for prostate cancer recurrence based on clinicopathological findings and other factors. Investigators documented their initial treatment plan for each subject and serially collected three serum samples for ProsVue testing. After the ProsVue result was reported, investigators recorded whether or not the initial treatment plan was changed. The proportion of cases referred for secondary treatment before and after ProsVue was reported, and the significance of the difference determined.

RESULTS:

Complete assessments were reported for 225 men, 128 (56.9%) of whom were stratified into intermediate- and high-risk groups. Investigators reported that they would have referred 41/128 (32.0%) at-risk men for secondary treatment. However, after results were known, they referred only 15/128 (11.7%) men. The difference in proportions (−20.3%, 95% confidence interval (CI) −29.9 to −10.3%) is significant (P<0.0001). Odds of a referral was significantly reduced after results were reported (odds ratio 0.28, 95% CI 0.15–0.54, P<0.0001).

CONCLUSIONS:

Knowledge of a ProsVue result had significant impact on the final treatment plan. A ProsVue result ⩽2.0 pg ml−1 month−1 significantly reduced the proportion of men at risk of recurrence who otherwise would have been referred for secondary treatment.

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Acknowledgements

Arista Molecular, a subsidiary of Beckman Coulter Diagnostics, provided final support to cover the costs for the collection and transportation of patient samples; the CLIA laboratory assayed specimens for each patient and reported the NADiA ProsVue slope results to the clinical sites.

Author information

Authors and Affiliations

  1. Division of Urologic Surgery, Duke University Medical Center, Durham, NC, USA

    J W Moul

  2. Department of Urologic Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA

    D Y T Chen

  3. Kimmel Cancer Center, Philadelphia, PA, USA

    E J Trabulsi

  4. Department of Urology, University of Minnesota, Minneapolis, MN, USA

    C A Warlick

  5. Department of Urologic Oncology, Loma Linda Medical Center, Loma Linda, CA, USA

    H C Ruckle

  6. Swedish Medical Center, Seattle, WA, USA

    J R Porter

  7. Department of Urologic Oncology, Hoag Memorial Hospital, Newport Beach, CA, USA

    J S Yoshida

  8. Urology Centers of Alabama, Homewood, AL, USA

    G W Adams

  9. Urology and Prostate Institute, San Antonio, TX, USA

    N Kella

  10. South Bay Urology, Torrance, CA, USA

    G S Matsunaga

  11. Prostate Solutions of Arizona, Phoenix, AZ, USA

    L L Bans

  12. Vision Biotechnology Consulting and Vision Clinical Research, Escondido, CA, USA

    M J Sarno

  13. Beckman Coulter, Carlsbad, CA, USA

    J E McDermed, M T Triebell & M A Reynolds

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on behalf of the investigators of the ProsVue Field Experience Trial

Corresponding author

Correspondence to J W Moul.

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Competing interests

MT, JMD and MR are employees of Beckman Coulter. The other authors declare no conflict of interest.

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Supplementary Information accompanies the paper on the Prostate Cancer and Prostatic Diseases website

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Moul, J., Chen, D., Trabulsi, E. et al. Impact of NADiA ProsVue PSA slope on secondary treatment decisions after radical prostatectomy. Prostate Cancer Prostatic Dis 17, 280–285 (2014). https://doi.org/10.1038/pcan.2014.25

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