Results of Phase 1 study on cytoreductive radical prostatectomy in men with newly diagnosed metastatic prostate cancer

Bertram E. Yuh, Young Suk Kwon, Brian M. Shinder, Eric A. Singer, Thomas L. Jang, S. Kim, Mark N. Stein, Tina Mayer, Anna Ferrari, Nara Lee, Rahul R. Parikh, Nora Ruel, Wun Jae Kim, Shigeo Horie, Seok-Soo Byun, Thomas E. Ahlering, Isaac Yi Kim

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background: Preclinical and retrospective data suggest that cytoreductive radical prostatectomy may benefit a subset of men who present with metastatic prostate cancer (mPCa). Herein, we report the results of the first planned Phase 1 study on cytoreductive surgery. Methods: From four institutions, 36 patients consented to the study. However, four did not complete surgery because of rapid disease progression (n = 3) and another because of an intraoperatively discovered pericolonic abscess. Men with newly diagnosed clinical mPCa to lymph nodes or bones were eligible. The primary endpoint was the rate of major perioperative complications (Clavien-Dindo Grade 3 or higher) occurring within 90 days of surgery. Results: The mean age at surgery was 64.0 years. The 90-day overall complication rate was 31.2% (n = 10), of which two (6.25%) were considered major complications: one acute tubular necrosis requiring temporary dialysis and one death. In men with more than 6 months of follow-up, 67.9% had prostate specific antigen nadir ≤0.2 ng/mL, while one patient experienced a rapid rise in prostate specific antigen and another a widely disseminated disease that resulted in death 5 months after surgery. Altogether, these results demonstrate that cytoreductive radical prostatectomy is safe and surgically feasible in selected patients who present with mPCa. Yet, there may be a small subset of patients in whom surgery may cause a significant harm. Conclusion: Therefore, cytoreductive surgery in men with mPCa should be limited to clinical trials until robust data are available.

Original languageEnglish
Pages (from-to)102-107
Number of pages6
JournalProstate International
Volume7
Issue number3
DOIs
StatePublished - 1 Sep 2019

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Prostatectomy
Prostatic Neoplasms
Prostate-Specific Antigen
Ambulatory Surgical Procedures
Abscess
Disease Progression
Dialysis
Necrosis
Lymph Nodes
Clinical Trials
Bone and Bones

Keywords

  • Clinical trial
  • Cytoreduction
  • Metastasis
  • Prostate cancer

Cite this

Yuh, Bertram E. ; Kwon, Young Suk ; Shinder, Brian M. ; Singer, Eric A. ; Jang, Thomas L. ; Kim, S. ; Stein, Mark N. ; Mayer, Tina ; Ferrari, Anna ; Lee, Nara ; Parikh, Rahul R. ; Ruel, Nora ; Kim, Wun Jae ; Horie, Shigeo ; Byun, Seok-Soo ; Ahlering, Thomas E. ; Kim, Isaac Yi. / Results of Phase 1 study on cytoreductive radical prostatectomy in men with newly diagnosed metastatic prostate cancer. In: Prostate International. 2019 ; Vol. 7, No. 3. pp. 102-107.
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title = "Results of Phase 1 study on cytoreductive radical prostatectomy in men with newly diagnosed metastatic prostate cancer",
abstract = "Background: Preclinical and retrospective data suggest that cytoreductive radical prostatectomy may benefit a subset of men who present with metastatic prostate cancer (mPCa). Herein, we report the results of the first planned Phase 1 study on cytoreductive surgery. Methods: From four institutions, 36 patients consented to the study. However, four did not complete surgery because of rapid disease progression (n = 3) and another because of an intraoperatively discovered pericolonic abscess. Men with newly diagnosed clinical mPCa to lymph nodes or bones were eligible. The primary endpoint was the rate of major perioperative complications (Clavien-Dindo Grade 3 or higher) occurring within 90 days of surgery. Results: The mean age at surgery was 64.0 years. The 90-day overall complication rate was 31.2{\%} (n = 10), of which two (6.25{\%}) were considered major complications: one acute tubular necrosis requiring temporary dialysis and one death. In men with more than 6 months of follow-up, 67.9{\%} had prostate specific antigen nadir ≤0.2 ng/mL, while one patient experienced a rapid rise in prostate specific antigen and another a widely disseminated disease that resulted in death 5 months after surgery. Altogether, these results demonstrate that cytoreductive radical prostatectomy is safe and surgically feasible in selected patients who present with mPCa. Yet, there may be a small subset of patients in whom surgery may cause a significant harm. Conclusion: Therefore, cytoreductive surgery in men with mPCa should be limited to clinical trials until robust data are available.",
keywords = "Clinical trial, Cytoreduction, Metastasis, Prostate cancer",
author = "Yuh, {Bertram E.} and Kwon, {Young Suk} and Shinder, {Brian M.} and Singer, {Eric A.} and Jang, {Thomas L.} and S. Kim and Stein, {Mark N.} and Tina Mayer and Anna Ferrari and Nara Lee and Parikh, {Rahul R.} and Nora Ruel and Kim, {Wun Jae} and Shigeo Horie and Seok-Soo Byun and Ahlering, {Thomas E.} and Kim, {Isaac Yi}",
year = "2019",
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doi = "10.1016/j.prnil.2018.10.002",
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Yuh, BE, Kwon, YS, Shinder, BM, Singer, EA, Jang, TL, Kim, S, Stein, MN, Mayer, T, Ferrari, A, Lee, N, Parikh, RR, Ruel, N, Kim, WJ, Horie, S, Byun, S-S, Ahlering, TE & Kim, IY 2019, 'Results of Phase 1 study on cytoreductive radical prostatectomy in men with newly diagnosed metastatic prostate cancer', Prostate International, vol. 7, no. 3, pp. 102-107. https://doi.org/10.1016/j.prnil.2018.10.002

Results of Phase 1 study on cytoreductive radical prostatectomy in men with newly diagnosed metastatic prostate cancer. / Yuh, Bertram E.; Kwon, Young Suk; Shinder, Brian M.; Singer, Eric A.; Jang, Thomas L.; Kim, S.; Stein, Mark N.; Mayer, Tina; Ferrari, Anna; Lee, Nara; Parikh, Rahul R.; Ruel, Nora; Kim, Wun Jae; Horie, Shigeo; Byun, Seok-Soo; Ahlering, Thomas E.; Kim, Isaac Yi.

In: Prostate International, Vol. 7, No. 3, 01.09.2019, p. 102-107.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Results of Phase 1 study on cytoreductive radical prostatectomy in men with newly diagnosed metastatic prostate cancer

AU - Yuh, Bertram E.

AU - Kwon, Young Suk

AU - Shinder, Brian M.

AU - Singer, Eric A.

AU - Jang, Thomas L.

AU - Kim, S.

AU - Stein, Mark N.

AU - Mayer, Tina

AU - Ferrari, Anna

AU - Lee, Nara

AU - Parikh, Rahul R.

AU - Ruel, Nora

AU - Kim, Wun Jae

AU - Horie, Shigeo

AU - Byun, Seok-Soo

AU - Ahlering, Thomas E.

AU - Kim, Isaac Yi

PY - 2019/9/1

Y1 - 2019/9/1

N2 - Background: Preclinical and retrospective data suggest that cytoreductive radical prostatectomy may benefit a subset of men who present with metastatic prostate cancer (mPCa). Herein, we report the results of the first planned Phase 1 study on cytoreductive surgery. Methods: From four institutions, 36 patients consented to the study. However, four did not complete surgery because of rapid disease progression (n = 3) and another because of an intraoperatively discovered pericolonic abscess. Men with newly diagnosed clinical mPCa to lymph nodes or bones were eligible. The primary endpoint was the rate of major perioperative complications (Clavien-Dindo Grade 3 or higher) occurring within 90 days of surgery. Results: The mean age at surgery was 64.0 years. The 90-day overall complication rate was 31.2% (n = 10), of which two (6.25%) were considered major complications: one acute tubular necrosis requiring temporary dialysis and one death. In men with more than 6 months of follow-up, 67.9% had prostate specific antigen nadir ≤0.2 ng/mL, while one patient experienced a rapid rise in prostate specific antigen and another a widely disseminated disease that resulted in death 5 months after surgery. Altogether, these results demonstrate that cytoreductive radical prostatectomy is safe and surgically feasible in selected patients who present with mPCa. Yet, there may be a small subset of patients in whom surgery may cause a significant harm. Conclusion: Therefore, cytoreductive surgery in men with mPCa should be limited to clinical trials until robust data are available.

AB - Background: Preclinical and retrospective data suggest that cytoreductive radical prostatectomy may benefit a subset of men who present with metastatic prostate cancer (mPCa). Herein, we report the results of the first planned Phase 1 study on cytoreductive surgery. Methods: From four institutions, 36 patients consented to the study. However, four did not complete surgery because of rapid disease progression (n = 3) and another because of an intraoperatively discovered pericolonic abscess. Men with newly diagnosed clinical mPCa to lymph nodes or bones were eligible. The primary endpoint was the rate of major perioperative complications (Clavien-Dindo Grade 3 or higher) occurring within 90 days of surgery. Results: The mean age at surgery was 64.0 years. The 90-day overall complication rate was 31.2% (n = 10), of which two (6.25%) were considered major complications: one acute tubular necrosis requiring temporary dialysis and one death. In men with more than 6 months of follow-up, 67.9% had prostate specific antigen nadir ≤0.2 ng/mL, while one patient experienced a rapid rise in prostate specific antigen and another a widely disseminated disease that resulted in death 5 months after surgery. Altogether, these results demonstrate that cytoreductive radical prostatectomy is safe and surgically feasible in selected patients who present with mPCa. Yet, there may be a small subset of patients in whom surgery may cause a significant harm. Conclusion: Therefore, cytoreductive surgery in men with mPCa should be limited to clinical trials until robust data are available.

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KW - Metastasis

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