Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer

Recommendations from the prostate- specific antigen working group

Glenn J. Bubley, Michael A Carducci, William Dahut, Nancy Dawson, Danai Daliani, Mario Eisenberger, William D. Figg, Boris Freidlin, Susan Halabi, Gary Hudes, Maha Hussain, Richard Kaplan, Charles Myers, William Oh, Daniel P. Petrylak, Eddie Reed, Bruce Roth, Oliver Sartor, Howard Scher, Jonathan Simons & 6 others Victoria Sinibaldi, Eric J. Small, Matthew R. Smith, Donald L. Trump, Robin Vollmer, George Wilding

Research output: Contribution to journalArticle

Abstract

Purpose: Prostate-specific antigen (PSA) is a glycoprotein that is found almost exclusively in normal and neoplastic prostate cells. For patients with metastatic disease, changes in PSA will often antedate changes in bone scan. Furthermore, many but not all investigators have observed an association between a decline in PSA levels of 50% or greater and survival. Since the majority of phase II clinical trials for patients with androgen-independent prostate cancer (ALPC) have used PSA as a marker, we believed it was important for investigators to agree on definitions and values for a minimum set of parameters for eligibility and PSA declines and to develop a common approach to outcome analysis and reporting. We held a consensus conference with 26 leading investigators in the field of AlPC to define these parameters. Result: We defined four patient groups: (1) progressive measurable disease, (2) progressive bone metastasis, (3) stable metastases and a rising PSA, and (4) rising PSA and no other evidence of metastatic disease. The purpose of determining the number of patients whose PSA level drops in a phase II trial of AlPC is to guide the selection of agents for further testing and phase III trials. We propose that investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period. Some investigators may want to report additional measures of PSA changes (ie, 75% decline, 90% decline). Response duration and the time to PSA progression may also be important clinical end point. Conclusion: Through this consensus conference, we believe we have developed practical guidelines for using PSA as a measurement of outcome. Furthermore, the use of common standards is important as we determine which agents should progress to randomized trials which will use survival as an end point.

Original languageEnglish (US)
Pages (from-to)3461-3467
Number of pages7
JournalJournal of Clinical Oncology
Volume17
Issue number11
StatePublished - Nov 1999

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Phase II Clinical Trials
Prostate-Specific Antigen
Androgens
Prostatic Neoplasms
Guidelines
Research Personnel
Neoplasm Metastasis
Bone and Bones
Survival
Disease Progression
Prostate
Glycoproteins

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer : Recommendations from the prostate- specific antigen working group. / Bubley, Glenn J.; Carducci, Michael A; Dahut, William; Dawson, Nancy; Daliani, Danai; Eisenberger, Mario; Figg, William D.; Freidlin, Boris; Halabi, Susan; Hudes, Gary; Hussain, Maha; Kaplan, Richard; Myers, Charles; Oh, William; Petrylak, Daniel P.; Reed, Eddie; Roth, Bruce; Sartor, Oliver; Scher, Howard; Simons, Jonathan; Sinibaldi, Victoria; Small, Eric J.; Smith, Matthew R.; Trump, Donald L.; Vollmer, Robin; Wilding, George.

In: Journal of Clinical Oncology, Vol. 17, No. 11, 11.1999, p. 3461-3467.

Research output: Contribution to journalArticle

Bubley, GJ, Carducci, MA, Dahut, W, Dawson, N, Daliani, D, Eisenberger, M, Figg, WD, Freidlin, B, Halabi, S, Hudes, G, Hussain, M, Kaplan, R, Myers, C, Oh, W, Petrylak, DP, Reed, E, Roth, B, Sartor, O, Scher, H, Simons, J, Sinibaldi, V, Small, EJ, Smith, MR, Trump, DL, Vollmer, R & Wilding, G 1999, 'Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: Recommendations from the prostate- specific antigen working group', Journal of Clinical Oncology, vol. 17, no. 11, pp. 3461-3467.
Bubley, Glenn J. ; Carducci, Michael A ; Dahut, William ; Dawson, Nancy ; Daliani, Danai ; Eisenberger, Mario ; Figg, William D. ; Freidlin, Boris ; Halabi, Susan ; Hudes, Gary ; Hussain, Maha ; Kaplan, Richard ; Myers, Charles ; Oh, William ; Petrylak, Daniel P. ; Reed, Eddie ; Roth, Bruce ; Sartor, Oliver ; Scher, Howard ; Simons, Jonathan ; Sinibaldi, Victoria ; Small, Eric J. ; Smith, Matthew R. ; Trump, Donald L. ; Vollmer, Robin ; Wilding, George. / Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer : Recommendations from the prostate- specific antigen working group. In: Journal of Clinical Oncology. 1999 ; Vol. 17, No. 11. pp. 3461-3467.
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abstract = "Purpose: Prostate-specific antigen (PSA) is a glycoprotein that is found almost exclusively in normal and neoplastic prostate cells. For patients with metastatic disease, changes in PSA will often antedate changes in bone scan. Furthermore, many but not all investigators have observed an association between a decline in PSA levels of 50{\%} or greater and survival. Since the majority of phase II clinical trials for patients with androgen-independent prostate cancer (ALPC) have used PSA as a marker, we believed it was important for investigators to agree on definitions and values for a minimum set of parameters for eligibility and PSA declines and to develop a common approach to outcome analysis and reporting. We held a consensus conference with 26 leading investigators in the field of AlPC to define these parameters. Result: We defined four patient groups: (1) progressive measurable disease, (2) progressive bone metastasis, (3) stable metastases and a rising PSA, and (4) rising PSA and no other evidence of metastatic disease. The purpose of determining the number of patients whose PSA level drops in a phase II trial of AlPC is to guide the selection of agents for further testing and phase III trials. We propose that investigators report at a minimum a PSA decline of at least 50{\%} and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period. Some investigators may want to report additional measures of PSA changes (ie, 75{\%} decline, 90{\%} decline). Response duration and the time to PSA progression may also be important clinical end point. Conclusion: Through this consensus conference, we believe we have developed practical guidelines for using PSA as a measurement of outcome. Furthermore, the use of common standards is important as we determine which agents should progress to randomized trials which will use survival as an end point.",
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T2 - Recommendations from the prostate- specific antigen working group

AU - Bubley, Glenn J.

AU - Carducci, Michael A

AU - Dahut, William

AU - Dawson, Nancy

AU - Daliani, Danai

AU - Eisenberger, Mario

AU - Figg, William D.

AU - Freidlin, Boris

AU - Halabi, Susan

AU - Hudes, Gary

AU - Hussain, Maha

AU - Kaplan, Richard

AU - Myers, Charles

AU - Oh, William

AU - Petrylak, Daniel P.

AU - Reed, Eddie

AU - Roth, Bruce

AU - Sartor, Oliver

AU - Scher, Howard

AU - Simons, Jonathan

AU - Sinibaldi, Victoria

AU - Small, Eric J.

AU - Smith, Matthew R.

AU - Trump, Donald L.

AU - Vollmer, Robin

AU - Wilding, George

PY - 1999/11

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N2 - Purpose: Prostate-specific antigen (PSA) is a glycoprotein that is found almost exclusively in normal and neoplastic prostate cells. For patients with metastatic disease, changes in PSA will often antedate changes in bone scan. Furthermore, many but not all investigators have observed an association between a decline in PSA levels of 50% or greater and survival. Since the majority of phase II clinical trials for patients with androgen-independent prostate cancer (ALPC) have used PSA as a marker, we believed it was important for investigators to agree on definitions and values for a minimum set of parameters for eligibility and PSA declines and to develop a common approach to outcome analysis and reporting. We held a consensus conference with 26 leading investigators in the field of AlPC to define these parameters. Result: We defined four patient groups: (1) progressive measurable disease, (2) progressive bone metastasis, (3) stable metastases and a rising PSA, and (4) rising PSA and no other evidence of metastatic disease. The purpose of determining the number of patients whose PSA level drops in a phase II trial of AlPC is to guide the selection of agents for further testing and phase III trials. We propose that investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period. Some investigators may want to report additional measures of PSA changes (ie, 75% decline, 90% decline). Response duration and the time to PSA progression may also be important clinical end point. Conclusion: Through this consensus conference, we believe we have developed practical guidelines for using PSA as a measurement of outcome. Furthermore, the use of common standards is important as we determine which agents should progress to randomized trials which will use survival as an end point.

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