Treatment with finasteride following radical prostatectomy for prostate cancer

G. Andriole, M. Lieber, J. Smith, M. Soloway, F. Schroeder, D. Kadmon, J. Dekernion, J. Rajfer, R. Boake, D. Crawford, E. Ramsey, J. Perreault, J. Trachtenberg, Y. Fradet, Norman L Block, R. Middleton, J. Ng, D. Ferguson, G. Gormley

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Abstract

Objectives: The objective of this study was to evaluate the effect of finasteride (10 mg/d) or placebo on serum prostate-specific antigen (PSA) and recurrence rates in men with detectable PSA levels after radical prostatectomy. Methods: A total of 120 men, 48 to 89 years old, previously treated with radical prostatectomy for prostate cancer within the past 10 years, with serum PSA levels between 0.6 and 10.0 ng/mL, with no evidence of skeletal metastasis on bone scan and with no previous androgen deprivation therapy, were treated with 10 mg finasteride or placebo in a double-blind fashion for 12 months. After the first year, all patients were treated with finasteride for an additional 12 months. Primary endpoints were serum PSA levels and recurrence rates defined as positive bone scan or positive biopsy. Results: Patients treated with finasteride had a delayed increase in serum PSA compared with placebo of approximately 9 months in the first year and 14 months by the end of the second year. Patients with baseline PSA levels less then 1.0 ng/mL had no significant increase in serum PSA during the 2 years of treatment. Fewer recurrences were observed in the finasteride group, but these differences were not statistically significant. Finasteride was well tolerated, and side effects were balanced between treatment groups. Conclusions: The results of this study indicate that treatment with finasteride delays but does not prevent the rise in serum PSA observed in untreated patients with detectable PSA levels after radical prostatectomy. The reduction in local and distant recurrences in the finasteride group suggests that the effect on PSA reflects a direct effect on tumor growth without affecting the initial response to subsequent hormonal therapy. These data require confirmation by studies that are longer and larger, focused on demonstrating significant differences in progression rates and survival before the use of finasteride can be considered as an option for men with detectable PSA levels after radical prostatectomy.

Original languageEnglish
Pages (from-to)491-497
Number of pages7
JournalUrology
Volume45
Issue number3
DOIs
StatePublished - Jan 1 1995
Externally publishedYes

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Finasteride
Prostate-Specific Antigen
Prostatectomy
Prostatic Neoplasms
Serum
Therapeutics
Recurrence
Placebos
Bone and Bones
Androgens
Survival Rate

ASJC Scopus subject areas

  • Urology

Cite this

Andriole, G., Lieber, M., Smith, J., Soloway, M., Schroeder, F., Kadmon, D., ... Gormley, G. (1995). Treatment with finasteride following radical prostatectomy for prostate cancer. Urology, 45(3), 491-497. https://doi.org/10.1016/S0090-4295(99)80021-1

Treatment with finasteride following radical prostatectomy for prostate cancer. / Andriole, G.; Lieber, M.; Smith, J.; Soloway, M.; Schroeder, F.; Kadmon, D.; Dekernion, J.; Rajfer, J.; Boake, R.; Crawford, D.; Ramsey, E.; Perreault, J.; Trachtenberg, J.; Fradet, Y.; Block, Norman L; Middleton, R.; Ng, J.; Ferguson, D.; Gormley, G.

In: Urology, Vol. 45, No. 3, 01.01.1995, p. 491-497.

Research output: Contribution to journalArticle

Andriole, G, Lieber, M, Smith, J, Soloway, M, Schroeder, F, Kadmon, D, Dekernion, J, Rajfer, J, Boake, R, Crawford, D, Ramsey, E, Perreault, J, Trachtenberg, J, Fradet, Y, Block, NL, Middleton, R, Ng, J, Ferguson, D & Gormley, G 1995, 'Treatment with finasteride following radical prostatectomy for prostate cancer', Urology, vol. 45, no. 3, pp. 491-497. https://doi.org/10.1016/S0090-4295(99)80021-1
Andriole G, Lieber M, Smith J, Soloway M, Schroeder F, Kadmon D et al. Treatment with finasteride following radical prostatectomy for prostate cancer. Urology. 1995 Jan 1;45(3):491-497. https://doi.org/10.1016/S0090-4295(99)80021-1
Andriole, G. ; Lieber, M. ; Smith, J. ; Soloway, M. ; Schroeder, F. ; Kadmon, D. ; Dekernion, J. ; Rajfer, J. ; Boake, R. ; Crawford, D. ; Ramsey, E. ; Perreault, J. ; Trachtenberg, J. ; Fradet, Y. ; Block, Norman L ; Middleton, R. ; Ng, J. ; Ferguson, D. ; Gormley, G. / Treatment with finasteride following radical prostatectomy for prostate cancer. In: Urology. 1995 ; Vol. 45, No. 3. pp. 491-497.
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abstract = "Objectives: The objective of this study was to evaluate the effect of finasteride (10 mg/d) or placebo on serum prostate-specific antigen (PSA) and recurrence rates in men with detectable PSA levels after radical prostatectomy. Methods: A total of 120 men, 48 to 89 years old, previously treated with radical prostatectomy for prostate cancer within the past 10 years, with serum PSA levels between 0.6 and 10.0 ng/mL, with no evidence of skeletal metastasis on bone scan and with no previous androgen deprivation therapy, were treated with 10 mg finasteride or placebo in a double-blind fashion for 12 months. After the first year, all patients were treated with finasteride for an additional 12 months. Primary endpoints were serum PSA levels and recurrence rates defined as positive bone scan or positive biopsy. Results: Patients treated with finasteride had a delayed increase in serum PSA compared with placebo of approximately 9 months in the first year and 14 months by the end of the second year. Patients with baseline PSA levels less then 1.0 ng/mL had no significant increase in serum PSA during the 2 years of treatment. Fewer recurrences were observed in the finasteride group, but these differences were not statistically significant. Finasteride was well tolerated, and side effects were balanced between treatment groups. Conclusions: The results of this study indicate that treatment with finasteride delays but does not prevent the rise in serum PSA observed in untreated patients with detectable PSA levels after radical prostatectomy. The reduction in local and distant recurrences in the finasteride group suggests that the effect on PSA reflects a direct effect on tumor growth without affecting the initial response to subsequent hormonal therapy. These data require confirmation by studies that are longer and larger, focused on demonstrating significant differences in progression rates and survival before the use of finasteride can be considered as an option for men with detectable PSA levels after radical prostatectomy.",
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AU - Kadmon, D.

AU - Dekernion, J.

AU - Rajfer, J.

AU - Boake, R.

AU - Crawford, D.

AU - Ramsey, E.

AU - Perreault, J.

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