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Journal of Clinical Oncology, Vol 17, Issue 11 (November), 1999: 3461-3467
© 1999 American Society for Clinical Oncology

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 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, Vickie Sinibaldi, Eric J. Small, Matthew R. Smith, Donald L. Trump, Robin Vollmer, George Wilding

From the Beth Israel Deaconess Medical CenterDana Farber Cancer Center, and Massachusetts General Hospital, Boston, MA; Johns Hopkins University, Baltimore, MD, National Cancer Institute, Bethesda, MD, University of Maryland, Baltimore, MD, MD Anderson Cancer Center, Houston, TX, Duke University, Durham, NC, Fox Chase Cancer Center, Philadelphia, PA, Wayne State University, Detroit, MI, University of Virginia, Charlottesville, VA, Columbia University, New York, NY, Vanderbilt University, Louisiana State Medical Center, New Orleans, LA, Memorial Sloan Kettering Cancer Center, New York, NY, University of California at San Francisco, San Francisco, CA, Massachusetts General Hospital, Boston, MA, University of Pittsburgh, Pittsburgh, PA, and University of Wisconsin, Madison, WI.

Address reprint requests to William D. Figg, PharmD, Bldg 10, Room 5A01, Medicine Branch, National Cancer Institute, 9000 Rockville Pike, Bethesda, MD 20892; email wdfigg{at}helix.nih.gov

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 (AIPC) 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 AIPC 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 AIPC 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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Interleukin 6, a Nuclear Factor-{kappa}B Target, Predicts Resistance to Docetaxel in Hormone-Independent Prostate Cancer and Nuclear Factor-{kappa}B Inhibition by PS-1145 Enhances Docetaxel Antitumor Activity.
Clin. Cancer Res., September 15, 2006; 12(18): 5578 - 5586.
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E. J. Small, P. F. Schellhammer, C. S. Higano, C. H. Redfern, J. J. Nemunaitis, F. H. Valone, S. S. Verjee, L. A. Jones, and R. M. Hershberg
Placebo-Controlled Phase III Trial of Immunologic Therapy with Sipuleucel-T (APC8015) in Patients with Metastatic, Asymptomatic Hormone Refractory Prostate Cancer
J. Clin. Oncol., July 1, 2006; 24(19): 3089 - 3094.
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M. R. Smith, J. Manola, D. S. Kaufman, W. K. Oh, G. J. Bubley, and P. W. Kantoff
Celecoxib Versus Placebo for Men With Prostate Cancer and a Rising Serum Prostate-Specific Antigen After Radical Prostatectomy and/or Radiation Therapy
J. Clin. Oncol., June 20, 2006; 24(18): 2723 - 2728.
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J. W. Simons, M. A. Carducci, B. Mikhak, M. Lim, B. Biedrzycki, F. Borellini, S. M. Clift, K. M. Hege, D. G. Ando, S. Piantadosi, et al.
Phase I/II Trial of an Allogeneic Cellular Immunotherapy in Hormone-Naive Prostate Cancer.
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T. M. Beer, M. Garzotto, B. Park, M. Mori, A. Myrthue, N. Janeba, D. Sauer, and K. Eilers
Effect of Calcitriol on Prostate-Specific Antigen In vitro and in Humans.
Clin. Cancer Res., May 1, 2006; 12(9): 2812 - 2816.
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C. P. Tarassoff, P. M. Arlen, and J. L. Gulley
Therapeutic vaccines for prostate cancer.
Oncologist, May 1, 2006; 11(5): 451 - 462.
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D. P. Petrylak, D. P. Ankerst, C. S. Jiang, C. M. Tangen, M. H. A. Hussain, P. N. Lara Jr., J. A. Jones, M. E. Taplin, P. A. Burch, M. Kohli, et al.
Evaluation of prostate-specific antigen declines for surrogacy in patients treated on SWOG 99-16.
J Natl Cancer Inst, April 19, 2006; 98(8): 516 - 521.
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P. N. Lara Jr., W. M. Stadler, J. Longmate, D. I. Quinn, J. Wexler, M. Van Loan, P. Twardowski, P. H. Gumerlock, N. J. Vogelzang, E. E. Vokes, et al.
A Randomized Phase II Trial of the Matrix Metalloproteinase Inhibitor BMS-275291 in Hormone-Refractory Prostate Cancer Patients with Bone Metastases
Clin. Cancer Res., March 1, 2006; 12(5): 1556 - 1563.
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P. M. Arlen, J. L. Gulley, C. Parker, L. Skarupa, M. Pazdur, D. Panicali, P. Beetham, K. Y. Tsang, D. W. Grosenbach, J. Feldman, et al.
A Randomized Phase II Study of Concurrent Docetaxel Plus Vaccine Versus Vaccine Alone in Metastatic Androgen-Independent Prostate Cancer
Clin. Cancer Res., February 15, 2006; 12(4): 1260 - 1269.
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M. Hussain, C. M. Tangen, P. N. Lara Jr, U. N. Vaishampayan, D. P. Petrylak, A. D. Colevas, W. A. Sakr, and E. D. Crawford
Ixabepilone (Epothilone B Analogue BMS-247550) Is Active in Chemotherapy-Naive Patients With Hormone-Refractory Prostate Cancer: A Southwest Oncology Group Trial S0111
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R. W. Ross, S. Halabi, S.-S. Ou, B. R. Rajeshkumar, B. A. Woda, N. J. Vogelzang, E. J. Small, M.-E. Taplin, and P. W. Kantoff
Predictors of Prostate Cancer Tissue Acquisition by an Undirected Core Bone Marrow Biopsy in Metastatic Castration-Resistant Prostate Cancer--A Cancer and Leukemia Group B Study
Clin. Cancer Res., November 15, 2005; 11(22): 8109 - 8113.
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H. I. Scher and C. L. Sawyers
Biology of Progressive, Castration-Resistant Prostate Cancer: Directed Therapies Targeting the Androgen-Receptor Signaling Axis
J. Clin. Oncol., November 10, 2005; 23(32): 8253 - 8261.
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W. M. Stadler, L. C. Michaelis, and M. J. Ratain
Randomized Phase II Trials and Prostate-Specific Antigen Endpoints in Prostate Cancer: Much Ado About Nothing?
J. Clin. Oncol., November 1, 2005; 23(31): 8124 - 8125.
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C. Sweeney, G. Liu, C. Yiannoutsos, J. Kolesar, D. Horvath, M. J. Staab, K. Fife, V. Armstrong, A. Treston, C. Sidor, et al.
A Phase II Multicenter, Randomized, Double-Blind, Safety Trial Assessing the Pharmacokinetics, Pharmacodynamics, and Efficacy of Oral 2-Methoxyestradiol Capsules in Hormone-Refractory Prostate Cancer
Clin. Cancer Res., September 15, 2005; 11(18): 6625 - 6633.
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K. J. Pienta and D. C. Smith
Advances in Prostate Cancer Chemotherapy: A New Era Begins
CA Cancer J Clin, September 1, 2005; 55(5): 300 - 318.
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R. W. Ross, J. Manola, K. Hennessy, M. Galsky, H. Scher, E. Small, W. K. Kelly, and P. W. Kantoff
Prognostic Significance of Baseline Reverse Transcriptase-PCR for Prostate-Specific Antigen in Men with Hormone-Refractory Prostate Cancer Treated with Chemotherapy
Clin. Cancer Res., July 15, 2005; 11(14): 5195 - 5198.
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H. I. Scher, M. J. Morris, W. K. Kelly, L. H. Schwartz, and G. Heller
Prostate Cancer Clinical Trial End Points: "RECIST"ing a Step Backwards
Clin. Cancer Res., July 15, 2005; 11(14): 5223 - 5232.
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P. G. Febbo, J. P. Richie, D. J. George, M. Loda, J. Manola, S. Shankar, A. Szot Barnes, C. Tempany, W. Catalona, P. W. Kantoff, et al.
Neoadjuvant Docetaxel before Radical Prostatectomy in Patients with High-Risk Localized Prostate Cancer
Clin. Cancer Res., July 15, 2005; 11(14): 5233 - 5240.
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N. Sharifi, J. L. Gulley, and W. L. Dahut
Androgen Deprivation Therapy for Prostate Cancer
JAMA, July 13, 2005; 294(2): 238 - 244.
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S. Oudard, E. Banu, P. Beuzeboc, E. Voog, L. M. Dourthe, A. C. Hardy-Bessard, C. Linassier, F. Scotte, A. Banu, Y. Coscas, et al.
Multicenter Randomized Phase II Study of Two Schedules of Docetaxel, Estramustine, and Prednisone Versus Mitoxantrone Plus Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer
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A. Hussain, N. Dawson, P. Amin, C. Engstrom, B. Dorsey, E. Siegel, and C. Guo
Docetaxel Followed by Hormone Therapy in Men Experiencing Increasing Prostate-Specific Antigen After Primary Local Treatments for Prostate Cancer
J. Clin. Oncol., April 20, 2005; 23(12): 2789 - 2796.
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M. D. Galsky, E. J. Small, W. K. Oh, I. Chen, D. C. Smith, A. D. Colevas, L. Martone, T. Curley, A. DeLaCruz, H. I. Scher, et al.
Multi-Institutional Randomized Phase II Trial of the Epothilone B Analog Ixabepilone (BMS-247550) With or Without Estramustine Phosphate in Patients With Progressive Castrate Metastatic Prostate Cancer
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A. Font, A. Murias, F. R. Garcia Arroyo, C. Martin, J. Areal, J. J. Sanchez, J. A. Santiago, M. Constenla, J. M. Saladie, and R. Rosell
Sequential mitoxantrone/prednisone followed by docetaxel/estramustine in patients with hormone refractory metastatic prostate cancer: results of a phase II study
Ann. Onc., March 1, 2005; 16(3): 419 - 424.
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J. M. Rademaker-Lakhai, S. Horenblas, W. Meinhardt, E. Stokvis, T. M. de Reijke, J. M. Jimeno, L. Lopez-Lazaro, J. A. Lopez Martin, J. H. Beijnen, and J. H.M. Schellens
Phase I Clinical and Pharmacokinetic Study of Kahalalide F in Patients with Advanced Androgen Refractory Prostate Cancer
Clin. Cancer Res., March 1, 2005; 11(5): 1854 - 1862.
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C.M. Canil, M.J. Moore, E. Winquist, T. Baetz, M. Pollak, K.N. Chi, S. Berry, D.S. Ernst, L. Douglas, M. Brundage, et al.
Randomized Phase II Study of Two Doses of Gefitinib in Hormone-Refractory Prostate Cancer: A Trial of the National Cancer Institute of Canada-Clinical Trials Group
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W. K. Oh, E. Hagmann, J. Manola, D. J. George, T. D. Gilligan, J. O. Jacobson, M. R. Smith, D. S. Kaufman, and P. W. Kantoff
A Phase I Study of Estramustine, Weekly Docetaxel, and Carboplatin Chemotherapy in Patients with Hormone-Refractory Prostate Cancer
Clin. Cancer Res., January 1, 2005; 11(1): 284 - 289.
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T. G. Roberts Jr, B. H. Goulart, L. Squitieri, S. C. Stallings, E. F. Halpern, B. A. Chabner, G. S. Gazelle, S. N. Finkelstein, and J. W. Clark
Trends in the Risks and Benefits to Patients With Cancer Participating in Phase 1 Clinical Trials
JAMA, November 3, 2004; 292(17): 2130 - 2140.
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F. Joly and I. F. Tannock
Chemotherapy for patients with hormone-refractory prostate cancer
Ann. Onc., November 1, 2004; 15(11): 1582 - 1584.
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R. P. Abratt, D. Brune, M.-A. Dimopoulos, J. Kliment, J. Breza, F. P. Selvaggi, P. Beuzeboc, T. Demkow, and S. Oudard
Randomised phase III study of intravenous vinorelbine plus hormone therapy versus hormone therapy alone in hormone-refractory prostate cancer
Ann. Onc., November 1, 2004; 15(11): 1613 - 1621.
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D. P. Petrylak, C. M. Tangen, M. H.A. Hussain, P. N. Lara Jr., J. A. Jones, M. E. Taplin, P. A. Burch, D. Berry, C. Moinpour, M. Kohli, et al.
Docetaxel and Estramustine Compared with Mitoxantrone and Prednisone for Advanced Refractory Prostate Cancer
N. Engl. J. Med., October 7, 2004; 351(15): 1513 - 1520.
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K. Fizazi, S. Culine, A. Kramar, R. J. Amato, J. Bouzy, I. Chen, J.-P. Droz, and C. J. Logothetis
Early Predicted Time to Normalization of Tumor Markers Predicts Outcome in Poor-Prognosis Nonseminomatous Germ Cell Tumors
J. Clin. Oncol., October 1, 2004; 22(19): 3868 - 3876.
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W. K. Oh, P. W. Kantoff, V. Weinberg, G. Jones, B. I. Rini, M. K. Derynck, R. Bok, M. R. Smith, G. J. Bubley, R. T. Rosen, et al.
Prospective, Multicenter, Randomized Phase II Trial of the Herbal Supplement, PC-SPES, and Diethylstilbestrol in Patients With Androgen-Independent Prostate Cancer
J. Clin. Oncol., September 15, 2004; 22(18): 3705 - 3712.
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 JCOHome page
W. L. Dahut, J. L. Gulley, P. M. Arlen, Y. Liu, K. M. Fedenko, S. M. Steinberg, J. J. Wright, H. Parnes, C. C. Chen, E. Jones, et al.
Randomized Phase II Trial of Docetaxel Plus Thalidomide in Androgen-Independent Prostate Cancer
J. Clin. Oncol., July 1, 2004; 22(13): 2532 - 2539.
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M. Koutsilieris, C. S. Mitsiades, J. Bogdanos, T. Dimopoulos, D. Karamanolakis, C. Milathianakis, and A. Tsintavis
Combination of Somatostatin Analog, Dexamethasone, and Standard Androgen Ablation Therapy in Stage D3 Prostate Cancer Patients with Bone Metastases
Clin. Cancer Res., July 1, 2004; 10(13): 4398 - 4405.
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 Stat Methods Med ResHome page
G. Molenberghs, T. Burzykowski, A. Alonso, and M. Buyse
A perspective on surrogate endpoints in controlled clinical trials
Statistical Methods in Medical Research, June 1, 2004; 13(3): 177 - 206.
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C. N. Papandreou, D. D. Daliani, D. Nix, H. Yang, T. Madden, X. Wang, C. S. Pien, R. E. Millikan, S.-M. Tu, L. Pagliaro, et al.
Phase I Trial of the Proteasome Inhibitor Bortezomib in Patients With Advanced Solid Tumors With Observations in Androgen-Independent Prostate Cancer
J. Clin. Oncol., June 1, 2004; 22(11): 2108 - 2121.
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W. M. Stadler, D. Cao, N. J. Vogelzang, C. W. Ryan, K. Hoving, R. Wright, T. Karrison, and E. E. Vokes
A Randomized Phase II Trial of the Antiangiogenic Agent SU5416 in Hormone-Refractory Prostate Cancer
Clin. Cancer Res., May 15, 2004; 10(10): 3365 - 3370.
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S. M. O'Hara, J. G. Moreno, D. R. Zweitzig, S. Gross, L. G. Gomella, and L. W.M.M. Terstappen
Multigene Reverse Transcription-PCR Profiling of Circulating Tumor Cells in Hormone-Refractory Prostate Cancer
Clin. Chem., May 1, 2004; 50(5): 826 - 835.
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M. D. Michaelson, R. M. Marujo, and M. R. Smith
Contribution of Androgen Deprivation Therapy to Elevated Osteoclast Activity in Men with Metastatic Prostate Cancer
Clin. Cancer Res., April 15, 2004; 10(8): 2705 - 2708.
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E. J. Small, S. Halabi, N. A. Dawson, W. M. Stadler, B. I. Rini, J. Picus, P. Gable, F. M. Torti, E. Kaplan, and N. J. Vogelzang
Antiandrogen Withdrawal Alone or in Combination With Ketoconazole in Androgen-Independent Prostate Cancer Patients: A Phase III Trial (CALGB 9583)
J. Clin. Oncol., March 15, 2004; 22(6): 1025 - 1033.
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