Advertisement
Journal of Clinical Oncology  
Search for:
Limit by:
  Browse by Subject or Issue
Home Search or Browse JCO My JCO Subscriptions Customer Service Site Map

Journal of Clinical Oncology, Vol 22, No 3 (February 1), 2004: pp. 537-556
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.07.099

This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Erratum (v22,p3205)
Right arrow Purchase Article
Right arrow View Shopping Cart
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a colleague
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Save to my personal folders
Right arrow Download to citation manager
Right arrowRights & Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Scher, H. I.
Right arrow Articles by Soule, H. R.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Scher, H. I.
Right arrow Articles by Soule, H. R.
Social Bookmarking
 Add to CiteULike   Add to Complore   Add to Connotea   Add to Del.icio.us   Add to Digg   Add to Facebook   Add to Reddit   Add to Technorati   Add to Twitter  
What's this?

SPECIAL ARTICLE

Eligibility and Outcomes Reporting Guidelines for Clinical Trials for Patients in the State of a Rising Prostate-Specific Antigen: Recommendations From the Prostate-Specific Antigen Working Group

Howard I. Scher, Mario Eisenberger, Anthony V. D'Amico, Susan Halabi, Eric J. Small, Michael Morris, Michael W. Kattan, Mack Roach, Philip Kantoff, Kenneth J. Pienta, Michael A. Carducci, David Agus, Susan F. Slovin, Glenn Heller, William Kevin Kelly, Paul H. Lange, Daniel Petrylak, William Berg, Celestra Higano, George Wilding, Judd W. Moul, Alan N. Partin, Christopher Logothetis, Howard R. Soule

From the Memorial Sloan-Kettering Cancer Center; Columbia Presbyterian Medical Center, New York, NY; Brigham and Women's Hospital; Dana- Farber Cancer Institute, Boston, MA; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; University of California San Francisco, San Francisco; Prostate Cancer Center, Cedars-Sinai, Los Angeles; the Prostate Cancer Foundation (CaP CURE), Santa Monica, CA; Duke University, Durham, NC; University of Michigan, Ann Arbor, MI; University of Washington, Seattle, WA; Aventis Pharmaceuticals, Bridgewater, NJ; University of Wisconsin Comprehensive Cancer Center, Madison, WI; Uniformed Services University, Rockville; The Johns Hopkins Hospital, Baltimore, MD; and the University of Texas M.D. Anderson Cancer Center, Houston, TX. (Additional participants are listed in Appendix B.)

Address reprint requests to Howard I. Scher, MD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021; e-mail: scherh{at}mskcc.org

PURPOSE: To define methodology to show clinical benefit for patients in the state of a rising prostate-specific antigen (PSA).

RESULTS: Hypothesis. A clinical states framework was used to address the hypothesis that definitive phase III trials could not be conducted in this patient population.

Patient Population. The Group focused on men with systemic (nonlocalized) recurrence and a defined risk of developing clinically detectable metastases. Models to define systemic versus local recurrence, and risk of metastatic progression were discussed.

Intervention. Therapies that have shown favorable effects in more advanced clinical states; meaningful biologic surrogates of activity linked with efficacy in other tumor types; and/or effects on a target or pathway known to contribute to prostate cancer progression in this state can be considered for evaluation.

Outcomes. An intervention-specific posttherapy PSA-based outcome definition that would justify further testing should be described at the outset.

Reporting. Trial reports should include a table showing the number of patients who achieve a specific PSA-based outcome, the number who remain enrolled onto the trial, and the number who came off study at different time points. The term PSA response should be abandoned.

Trial Design. The phases of drug development for this state are optimizing dose and schedule, demonstration of a treatment effect, and clinical benefit. To move a drug forward should require a high bar that includes no rise in PSA in a defined proportion of patients for a specified period of time at a minimum. Agents that do not produce this effect can only be tested in combination. The preferred end point of clinical benefit is prostate cancer–specific survival; the time to development of metastatic disease is an alternative.

CONCLUSION: Methodology to show that an intervention alters the natural history of prostate cancer is described. At each stage of development, only agents with sufficient activity should be moved forward.

Supported by a Memorial Sloan-Kettering Cancer Center Specialized Program of Research Excellence grant in prostate cancer CA05826, the Prostate Cancer Foundation (CaP CURE), and the PepsiCo Foundation.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Facebook Facebook   Add to Reddit Reddit   Add to Technorati Technorati   Add to Twitter Twitter    What's this?


This article has been cited by other articles:


Home page
Anticancer ResHome page
S. SRINIVAS and D. FELDMAN
A Phase II Trial of Calcitriol and Naproxen in Recurrent Prostate Cancer
Anticancer Res, September 1, 2009; 29(9): 3605 - 3610.
[Abstract] [Full Text] [PDF]


Home page
Ann OncolHome page
H. A. Wakelee, A. Patnaik, B. I. Sikic, M. Mita, N. L. Fox, R. Miceli, S. J. Ullrich, G. A. Fisher, and A. W. Tolcher
Phase I and pharmacokinetic study of lexatumumab (HGS-ETR2) given every 2 weeks in patients with advanced solid tumors
Ann. Onc., July 24, 2009; (2009) mdp292v1.
[Abstract] [Full Text] [PDF]


Home page
Cancer Epidemiol. Biomarkers Prev.Home page
O. B. Goodman Jr., L. M. Fink, J. T. Symanowski, B. Wong, B. Grobaski, D. Pomerantz, Y. Ma, D. C. Ward, and N. J. Vogelzang
Circulating Tumor Cells in Patients with Castration-Resistant Prostate Cancer Baseline Values and Correlation with Prognostic Factors
Cancer Epidemiol. Biomarkers Prev., June 1, 2009; 18(6): 1904 - 1913.
[Abstract] [Full Text] [PDF]


Home page
JNMHome page
A. B. Apolo, N. Pandit-Taskar, and M. J. Morris
Novel Tracers and Their Development for the Imaging of Metastatic Prostate Cancer
J. Nucl. Med., December 1, 2008; 49(12): 2031 - 2041.
[Abstract] [Full Text] [PDF]


Home page
Clin. Cancer Res.Home page
R. Plummer, G. Attard, S. Pacey, L. Li, A. Razak, R. Perrett, M. Barrett, I. Judson, S. Kaye, N. L. Fox, et al.
Phase 1 and Pharmacokinetic Study of Lexatumumab in Patients with Advanced Cancers
Clin. Cancer Res., October 15, 2007; 13(20): 6187 - 6194.
[Abstract] [Full Text] [PDF]


Home page
Clin. Cancer Res.Home page
M. Gross, I. Top, I. Laux, J. Katz, J. Curran, C. Tindell, and D. Agus
{beta}-2-Microglobulin Is an Androgen-Regulated Secreted Protein Elevated in Serum of Patients with Advanced Prostate Cancer
Clin. Cancer Res., April 1, 2007; 13(7): 1979 - 1986.
[Abstract] [Full Text] [PDF]


Home page
Mayo Clin Proc.Home page
J. R. Walczak and M. A. Carducci
Prostate Cancer: A Practical Approach to Current Management of Recurrent Disease
Mayo Clin. Proc., February 1, 2007; 82(2): 243 - 249.
[Abstract] [Full Text] [PDF]


Home page
JCOHome page
A. J. Stephenson, M. W. Kattan, J. A. Eastham, Z. A. Dotan, F. J. Bianco Jr, H. Lilja, and P. T. Scardino
Defining Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy: A Proposal for a Standardized Definition
J. Clin. Oncol., August 20, 2006; 24(24): 3973 - 3978.
[Abstract] [Full Text] [PDF]


Home page
JCOHome page
H. M. Sandler
Exploring Dose-Intensity: Carefully Comparing High-Dose With Low-Dose External-Beam Radiotherapy for Prostate Cancer
J. Clin. Oncol., May 1, 2006; 24(13): 1975 - 1977.
[Full Text] [PDF]


Home page
JNCI J Natl Cancer InstHome page
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.
[Abstract] [Full Text] [PDF]


Home page
Clin. Cancer Res.Home page
S. F. Slovin, A. S. Wilton, G. Heller, and H. I. Scher
Time to Detectable Metastatic Disease in Patients with Rising Prostate-Specific Antigen Values following Surgery or Radiation Therapy
Clin. Cancer Res., December 15, 2005; 11(24): 8669 - 8673.
[Abstract] [Full Text] [PDF]


Home page
Clin. Cancer Res.Home page
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.
[Abstract] [Full Text] [PDF]


Home page
Clin. Cancer Res.Home page
H. Schoder, K. Herrmann, M. Gonen, H. Hricak, S. Eberhard, P. Scardino, H. I. Scher, and S. M. Larson
2-[18F]Fluoro-2-Deoxyglucose Positron Emission Tomography for the Detection of Disease in Patients with Prostate-Specific Antigen Relapse after Radical Prostatectomy
Clin. Cancer Res., July 1, 2005; 11(13): 4761 - 4769.
[Abstract] [Full Text] [PDF]


Home page
Clin. Cancer Res.Home page
E. Rosenbaum, M. Zahurak, V. Sinibaldi, M. A. Carducci, R. Pili, M. Laufer, T. L. DeWeese, and M. A. Eisenberger
Marimastat in the Treatment of Patients with Biochemically Relapsed Prostate Cancer: A Prospective Randomized, Double-Blind, Phase I/II Trial
Clin. Cancer Res., June 15, 2005; 11(12): 4437 - 4443.
[Abstract] [Full Text] [PDF]


Home page
JCOHome page
S. Goodin, P. Medina, T. Capanna, W. J. Shih, S. Abraham, J. Winnie, S. Doyle-Lindrud, M. Todd, and R. S. DiPaola
Effect of Docetaxel in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer
J. Clin. Oncol., May 20, 2005; 23(15): 3352 - 3357.
[Abstract] [Full Text] [PDF]


Home page
Clin. Cancer Res.Home page
M. J. Morris, T. Akhurst, S. M. Larson, M. Ditullio, E. Chu, K. Siedlecki, D. Verbel, G. Heller, W. K. Kelly, S. Slovin, et al.
Fluorodeoxyglucose Positron Emission Tomography as an Outcome Measure for Castrate Metastatic Prostate Cancer Treated with Antimicrotubule Chemotherapy
Clin. Cancer Res., May 1, 2005; 11(9): 3210 - 3216.
[Abstract] [Full Text] [PDF]


Home page
JCOHome page
H. L. Kaufman, W. Wang, J. Manola, R. S. DiPaola, Y.-J. Ko, C. Sweeney, T. L. Whiteside, J. Schlom, G. Wilding, and L. M. Weiner
Phase II Randomized Study of Vaccine Treatment of Advanced Prostate Cancer (E7897): A Trial of the Eastern Cooperative Oncology Group
J. Clin. Oncol., June 1, 2004; 22(11): 2122 - 2132.
[Abstract] [Full Text] [PDF]



About
JCO
 Editorial
Roster
 Advertising
Information
 Librarians &
Institutions
 Rights &
Permissions
 PDA Services

Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
Terms and Conditions of Use
  HighWire Press HighWire Press™ assists in the publication of JCO Online