Phase II trial of neoadjuvant docetaxel before radical prostatectomy for locally advanced prostate cancer

Robert Dreicer, Cristina Magi-Galluzzi, Ming Zhou, Jason Rothaermel, Alwyn Reuther, James Ulchaker, Craig Zippe, Amr Fergany, Eric A. Klein

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Abstract

Objectives To perform a Phase II trial of docetaxel administered on a weekly schedule for 6 weeks before radical prostatectomy (RP) in patients with locally advanced prostate cancer. Methods Treatment consisted of six doses of docetaxel 40 mg/m2 intravenously administered weekly for 6 weeks followed by RP. Eligibility criteria included clinical Stage T2b, prostate-specific antigen (PSA) level 15 ng/mL or greater or Gleason sum 8 or greater, and no evidence of metastatic disease. The primary endpoint was feasibility and drug-related and surgical-related toxicities. Secondary endpoints included pre-RP PSA level, local response, pathologic outcomes, and time to PSA failure. Results Twenty-nine patients were entered; 80% completed all 6 weeks of therapy and 97% underwent RP. The median PSA level was 12 ng/mL (range 2.5 to 43.3), the median Gleason sum was 8 (range 6 to 9), and all had Stage T2b or greater disease. A statistically significant reduction in the prechemotherapy versus postchemotherapy mean PSA level was observed (12.00 ± 1.86 ng/mL versus 8.42 ± 1.63 ng/mL, P <0.03), with 79% of patients experiencing some reduction and 24% a more than 50% reduction in PSA level in response to docetaxel alone. No unexpected toxicities and no intraoperative complications occurred. Pathologic analysis demonstrated residual carcinoma in all cases. Three patients (11%) had organ-confined disease, and 26 (93%) had achieved an undetectable PSA postoperatively. At a median follow-up of 23 months (range 1.5 to 36), 20 patients were disease free with no additional therapy. Conclusions This trial establishes the baseline effect of short-course high-dose docetaxel alone on locally advanced prostate cancer. Additional study of this paradigm with other agents alone and in combination with docetaxel seems warranted.

Original languageEnglish (US)
Pages (from-to)1138-1142
Number of pages5
JournalUrology
Volume63
Issue number6
DOIs
StatePublished - Jun 1 2004

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docetaxel
Prostate-Specific Antigen
Prostatectomy
Prostatic Neoplasms
Intraoperative Complications
Appointments and Schedules
Therapeutics

ASJC Scopus subject areas

  • Urology

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Dreicer, R., Magi-Galluzzi, C., Zhou, M., Rothaermel, J., Reuther, A., Ulchaker, J., ... Klein, E. A. (2004). Phase II trial of neoadjuvant docetaxel before radical prostatectomy for locally advanced prostate cancer. Urology, 63(6), 1138-1142. https://doi.org/10.1016/j.urology.2004.01.040

Phase II trial of neoadjuvant docetaxel before radical prostatectomy for locally advanced prostate cancer. / Dreicer, Robert; Magi-Galluzzi, Cristina; Zhou, Ming; Rothaermel, Jason; Reuther, Alwyn; Ulchaker, James; Zippe, Craig; Fergany, Amr; Klein, Eric A.

In: Urology, Vol. 63, No. 6, 01.06.2004, p. 1138-1142.

Research output: Contribution to journalArticle

Dreicer, R, Magi-Galluzzi, C, Zhou, M, Rothaermel, J, Reuther, A, Ulchaker, J, Zippe, C, Fergany, A & Klein, EA 2004, 'Phase II trial of neoadjuvant docetaxel before radical prostatectomy for locally advanced prostate cancer', Urology, vol. 63, no. 6, pp. 1138-1142. https://doi.org/10.1016/j.urology.2004.01.040
Dreicer R, Magi-Galluzzi C, Zhou M, Rothaermel J, Reuther A, Ulchaker J et al. Phase II trial of neoadjuvant docetaxel before radical prostatectomy for locally advanced prostate cancer. Urology. 2004 Jun 1;63(6):1138-1142. https://doi.org/10.1016/j.urology.2004.01.040
Dreicer, Robert ; Magi-Galluzzi, Cristina ; Zhou, Ming ; Rothaermel, Jason ; Reuther, Alwyn ; Ulchaker, James ; Zippe, Craig ; Fergany, Amr ; Klein, Eric A. / Phase II trial of neoadjuvant docetaxel before radical prostatectomy for locally advanced prostate cancer. In: Urology. 2004 ; Vol. 63, No. 6. pp. 1138-1142.
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abstract = "Objectives To perform a Phase II trial of docetaxel administered on a weekly schedule for 6 weeks before radical prostatectomy (RP) in patients with locally advanced prostate cancer. Methods Treatment consisted of six doses of docetaxel 40 mg/m2 intravenously administered weekly for 6 weeks followed by RP. Eligibility criteria included clinical Stage T2b, prostate-specific antigen (PSA) level 15 ng/mL or greater or Gleason sum 8 or greater, and no evidence of metastatic disease. The primary endpoint was feasibility and drug-related and surgical-related toxicities. Secondary endpoints included pre-RP PSA level, local response, pathologic outcomes, and time to PSA failure. Results Twenty-nine patients were entered; 80{\%} completed all 6 weeks of therapy and 97{\%} underwent RP. The median PSA level was 12 ng/mL (range 2.5 to 43.3), the median Gleason sum was 8 (range 6 to 9), and all had Stage T2b or greater disease. A statistically significant reduction in the prechemotherapy versus postchemotherapy mean PSA level was observed (12.00 ± 1.86 ng/mL versus 8.42 ± 1.63 ng/mL, P <0.03), with 79{\%} of patients experiencing some reduction and 24{\%} a more than 50{\%} reduction in PSA level in response to docetaxel alone. No unexpected toxicities and no intraoperative complications occurred. Pathologic analysis demonstrated residual carcinoma in all cases. Three patients (11{\%}) had organ-confined disease, and 26 (93{\%}) had achieved an undetectable PSA postoperatively. At a median follow-up of 23 months (range 1.5 to 36), 20 patients were disease free with no additional therapy. Conclusions This trial establishes the baseline effect of short-course high-dose docetaxel alone on locally advanced prostate cancer. Additional study of this paradigm with other agents alone and in combination with docetaxel seems warranted.",
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AU - Dreicer, Robert

AU - Magi-Galluzzi, Cristina

AU - Zhou, Ming

AU - Rothaermel, Jason

AU - Reuther, Alwyn

AU - Ulchaker, James

AU - Zippe, Craig

AU - Fergany, Amr

AU - Klein, Eric A.

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N2 - Objectives To perform a Phase II trial of docetaxel administered on a weekly schedule for 6 weeks before radical prostatectomy (RP) in patients with locally advanced prostate cancer. Methods Treatment consisted of six doses of docetaxel 40 mg/m2 intravenously administered weekly for 6 weeks followed by RP. Eligibility criteria included clinical Stage T2b, prostate-specific antigen (PSA) level 15 ng/mL or greater or Gleason sum 8 or greater, and no evidence of metastatic disease. The primary endpoint was feasibility and drug-related and surgical-related toxicities. Secondary endpoints included pre-RP PSA level, local response, pathologic outcomes, and time to PSA failure. Results Twenty-nine patients were entered; 80% completed all 6 weeks of therapy and 97% underwent RP. The median PSA level was 12 ng/mL (range 2.5 to 43.3), the median Gleason sum was 8 (range 6 to 9), and all had Stage T2b or greater disease. A statistically significant reduction in the prechemotherapy versus postchemotherapy mean PSA level was observed (12.00 ± 1.86 ng/mL versus 8.42 ± 1.63 ng/mL, P <0.03), with 79% of patients experiencing some reduction and 24% a more than 50% reduction in PSA level in response to docetaxel alone. No unexpected toxicities and no intraoperative complications occurred. Pathologic analysis demonstrated residual carcinoma in all cases. Three patients (11%) had organ-confined disease, and 26 (93%) had achieved an undetectable PSA postoperatively. At a median follow-up of 23 months (range 1.5 to 36), 20 patients were disease free with no additional therapy. Conclusions This trial establishes the baseline effect of short-course high-dose docetaxel alone on locally advanced prostate cancer. Additional study of this paradigm with other agents alone and in combination with docetaxel seems warranted.

AB - Objectives To perform a Phase II trial of docetaxel administered on a weekly schedule for 6 weeks before radical prostatectomy (RP) in patients with locally advanced prostate cancer. Methods Treatment consisted of six doses of docetaxel 40 mg/m2 intravenously administered weekly for 6 weeks followed by RP. Eligibility criteria included clinical Stage T2b, prostate-specific antigen (PSA) level 15 ng/mL or greater or Gleason sum 8 or greater, and no evidence of metastatic disease. The primary endpoint was feasibility and drug-related and surgical-related toxicities. Secondary endpoints included pre-RP PSA level, local response, pathologic outcomes, and time to PSA failure. Results Twenty-nine patients were entered; 80% completed all 6 weeks of therapy and 97% underwent RP. The median PSA level was 12 ng/mL (range 2.5 to 43.3), the median Gleason sum was 8 (range 6 to 9), and all had Stage T2b or greater disease. A statistically significant reduction in the prechemotherapy versus postchemotherapy mean PSA level was observed (12.00 ± 1.86 ng/mL versus 8.42 ± 1.63 ng/mL, P <0.03), with 79% of patients experiencing some reduction and 24% a more than 50% reduction in PSA level in response to docetaxel alone. No unexpected toxicities and no intraoperative complications occurred. Pathologic analysis demonstrated residual carcinoma in all cases. Three patients (11%) had organ-confined disease, and 26 (93%) had achieved an undetectable PSA postoperatively. At a median follow-up of 23 months (range 1.5 to 36), 20 patients were disease free with no additional therapy. Conclusions This trial establishes the baseline effect of short-course high-dose docetaxel alone on locally advanced prostate cancer. Additional study of this paradigm with other agents alone and in combination with docetaxel seems warranted.

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