Modeling and analysis of gleason score 8-10 prostate cancers in the REDUCE study

Gerald L. Andriole, David G. Bostwick, Leonard G. Gomella, Michael Marberger, Francesco Montorsi, Teuvo L. Tammela, Donald J. Tindall, Ivy L. Fowler, Harmony P. Garges, Timothy H. Wilson, Ramiro Castro

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Abstract

Objective To explore explanations for the numerical imbalance of biopsy-detected Gleason 8-10 prostate cancers (PCa) diagnosed in years 3-4 in the dutasteride and placebo groups of the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study. Methods REDUCE was a 4-year, randomized, double-blind, placebo-controlled trial of dutasteride (0.5 mg/d) vs placebo for PCa risk reduction. We modeled the incidence of Gleason 8-10 cancer and used logistic regression analysis to evaluate the effects of baseline predictors of PCa, as well as post-baseline prostate volume at the time of biopsy, on PCa diagnosis. We compared needle biopsy Gleason scores with corresponding surgery Gleason scores. All statistical tests conducted were 2-sided. Results Had there been a scheduled biopsy occurring only at year 4, we estimated a similar incidence of Gleason 8-10 PCa in the dutasteride (n = 45) and placebo (n = 46) groups. Two biopsy Gleason 7 cancers in the placebo group (n = 150) were upgraded to Gleason 8-10 cancer on prostatectomy, and no patients in the dutasteride group (n = 111) were upgraded. Logistic regression analysis demonstrated the effect of prostate volume on Gleason 8-10 cancer diagnosis. Conclusion Although modeling of REDUCE data showed a similar incidence of Gleason 8-10 cancer in the dutasteride and placebo groups at year 4, an association between dutasteride and Gleason 8-10 cancer cannot be definitely excluded. It is likely that several biases, notably study design and prostate size at the time of biopsy, contributed to the numerical imbalance in Gleason 8-10 cancers observed between the treatment groups in years 3-4.

Original languageEnglish (US)
Pages (from-to)393-399
Number of pages7
JournalUrology
Volume84
Issue number2
DOIs
StatePublished - 2014

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Neoplasm Grading
Prostatic Neoplasms
Placebos
Biopsy
Neoplasms
Prostate
Incidence
Logistic Models
Regression Analysis
Dutasteride
Needle Biopsy
Risk Reduction Behavior
Prostatectomy

ASJC Scopus subject areas

  • Urology

Cite this

Andriole, G. L., Bostwick, D. G., Gomella, L. G., Marberger, M., Montorsi, F., Tammela, T. L., ... Castro, R. (2014). Modeling and analysis of gleason score 8-10 prostate cancers in the REDUCE study. Urology, 84(2), 393-399. https://doi.org/10.1016/j.urology.2014.04.016

Modeling and analysis of gleason score 8-10 prostate cancers in the REDUCE study. / Andriole, Gerald L.; Bostwick, David G.; Gomella, Leonard G.; Marberger, Michael; Montorsi, Francesco; Tammela, Teuvo L.; Tindall, Donald J.; Fowler, Ivy L.; Garges, Harmony P.; Wilson, Timothy H.; Castro, Ramiro.

In: Urology, Vol. 84, No. 2, 2014, p. 393-399.

Research output: Contribution to journalArticle

Andriole, GL, Bostwick, DG, Gomella, LG, Marberger, M, Montorsi, F, Tammela, TL, Tindall, DJ, Fowler, IL, Garges, HP, Wilson, TH & Castro, R 2014, 'Modeling and analysis of gleason score 8-10 prostate cancers in the REDUCE study', Urology, vol. 84, no. 2, pp. 393-399. https://doi.org/10.1016/j.urology.2014.04.016
Andriole GL, Bostwick DG, Gomella LG, Marberger M, Montorsi F, Tammela TL et al. Modeling and analysis of gleason score 8-10 prostate cancers in the REDUCE study. Urology. 2014;84(2):393-399. https://doi.org/10.1016/j.urology.2014.04.016
Andriole, Gerald L. ; Bostwick, David G. ; Gomella, Leonard G. ; Marberger, Michael ; Montorsi, Francesco ; Tammela, Teuvo L. ; Tindall, Donald J. ; Fowler, Ivy L. ; Garges, Harmony P. ; Wilson, Timothy H. ; Castro, Ramiro. / Modeling and analysis of gleason score 8-10 prostate cancers in the REDUCE study. In: Urology. 2014 ; Vol. 84, No. 2. pp. 393-399.
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abstract = "Objective To explore explanations for the numerical imbalance of biopsy-detected Gleason 8-10 prostate cancers (PCa) diagnosed in years 3-4 in the dutasteride and placebo groups of the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study. Methods REDUCE was a 4-year, randomized, double-blind, placebo-controlled trial of dutasteride (0.5 mg/d) vs placebo for PCa risk reduction. We modeled the incidence of Gleason 8-10 cancer and used logistic regression analysis to evaluate the effects of baseline predictors of PCa, as well as post-baseline prostate volume at the time of biopsy, on PCa diagnosis. We compared needle biopsy Gleason scores with corresponding surgery Gleason scores. All statistical tests conducted were 2-sided. Results Had there been a scheduled biopsy occurring only at year 4, we estimated a similar incidence of Gleason 8-10 PCa in the dutasteride (n = 45) and placebo (n = 46) groups. Two biopsy Gleason 7 cancers in the placebo group (n = 150) were upgraded to Gleason 8-10 cancer on prostatectomy, and no patients in the dutasteride group (n = 111) were upgraded. Logistic regression analysis demonstrated the effect of prostate volume on Gleason 8-10 cancer diagnosis. Conclusion Although modeling of REDUCE data showed a similar incidence of Gleason 8-10 cancer in the dutasteride and placebo groups at year 4, an association between dutasteride and Gleason 8-10 cancer cannot be definitely excluded. It is likely that several biases, notably study design and prostate size at the time of biopsy, contributed to the numerical imbalance in Gleason 8-10 cancers observed between the treatment groups in years 3-4.",
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AU - Andriole, Gerald L.

AU - Bostwick, David G.

AU - Gomella, Leonard G.

AU - Marberger, Michael

AU - Montorsi, Francesco

AU - Tammela, Teuvo L.

AU - Tindall, Donald J.

AU - Fowler, Ivy L.

AU - Garges, Harmony P.

AU - Wilson, Timothy H.

AU - Castro, Ramiro

PY - 2014

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N2 - Objective To explore explanations for the numerical imbalance of biopsy-detected Gleason 8-10 prostate cancers (PCa) diagnosed in years 3-4 in the dutasteride and placebo groups of the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study. Methods REDUCE was a 4-year, randomized, double-blind, placebo-controlled trial of dutasteride (0.5 mg/d) vs placebo for PCa risk reduction. We modeled the incidence of Gleason 8-10 cancer and used logistic regression analysis to evaluate the effects of baseline predictors of PCa, as well as post-baseline prostate volume at the time of biopsy, on PCa diagnosis. We compared needle biopsy Gleason scores with corresponding surgery Gleason scores. All statistical tests conducted were 2-sided. Results Had there been a scheduled biopsy occurring only at year 4, we estimated a similar incidence of Gleason 8-10 PCa in the dutasteride (n = 45) and placebo (n = 46) groups. Two biopsy Gleason 7 cancers in the placebo group (n = 150) were upgraded to Gleason 8-10 cancer on prostatectomy, and no patients in the dutasteride group (n = 111) were upgraded. Logistic regression analysis demonstrated the effect of prostate volume on Gleason 8-10 cancer diagnosis. Conclusion Although modeling of REDUCE data showed a similar incidence of Gleason 8-10 cancer in the dutasteride and placebo groups at year 4, an association between dutasteride and Gleason 8-10 cancer cannot be definitely excluded. It is likely that several biases, notably study design and prostate size at the time of biopsy, contributed to the numerical imbalance in Gleason 8-10 cancers observed between the treatment groups in years 3-4.

AB - Objective To explore explanations for the numerical imbalance of biopsy-detected Gleason 8-10 prostate cancers (PCa) diagnosed in years 3-4 in the dutasteride and placebo groups of the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study. Methods REDUCE was a 4-year, randomized, double-blind, placebo-controlled trial of dutasteride (0.5 mg/d) vs placebo for PCa risk reduction. We modeled the incidence of Gleason 8-10 cancer and used logistic regression analysis to evaluate the effects of baseline predictors of PCa, as well as post-baseline prostate volume at the time of biopsy, on PCa diagnosis. We compared needle biopsy Gleason scores with corresponding surgery Gleason scores. All statistical tests conducted were 2-sided. Results Had there been a scheduled biopsy occurring only at year 4, we estimated a similar incidence of Gleason 8-10 PCa in the dutasteride (n = 45) and placebo (n = 46) groups. Two biopsy Gleason 7 cancers in the placebo group (n = 150) were upgraded to Gleason 8-10 cancer on prostatectomy, and no patients in the dutasteride group (n = 111) were upgraded. Logistic regression analysis demonstrated the effect of prostate volume on Gleason 8-10 cancer diagnosis. Conclusion Although modeling of REDUCE data showed a similar incidence of Gleason 8-10 cancer in the dutasteride and placebo groups at year 4, an association between dutasteride and Gleason 8-10 cancer cannot be definitely excluded. It is likely that several biases, notably study design and prostate size at the time of biopsy, contributed to the numerical imbalance in Gleason 8-10 cancers observed between the treatment groups in years 3-4.

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