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Prostate Cancer End Points Workshop Presentations
Monday, June 21, 2004
Introductory Overview: End Points to Measure
Therapeutic Efficacy in Prostate Cancer
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Regulatory Background, Richard Pazdur M.D., FDA
[HTML] or [PPT]
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Relevance of Prostate Cancer Clinical States to
End Points and PSA End Point Application Methodologies. Howard
I. Scher M.D., Memorial Smith-Kettering Cancer Center [HTML] or [PPT]
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Statistical Issues in the Validation of
Surrogate Endpoints -- With a focus on the evaluation of
treatments for prostate cancer, Stuart G. Baker ScD., NCI, NIH [HTML]
or [PPT].
Accompanying article.
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Prostate Cancer Specific Mortality - Clinical Issues in
its Use in Surrogate Validation, Peter C. Albertsen M.D.,
University of Connecticut [HTML] or [PPT]
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Monitoring Treatment Response of Prostate
Cancer: Bone Scan and Beyond, Steve Larson, Memorial Sloan
Kettering Cancer Center [HTML] or [PPT]
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Re-evaluation of Radiographic Outcomes: The
Casodex Early Prostate Cancer Trial Program Experience, Kevin Carroll, MSc, FRSS, AstraZeneca
Pharmaceuticals [HTML] or [PPT]
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Patient Reported Outcomes in Prostate Cancer, Derek Raghavan, M.D.,
Ph.D. Cleveland Clinic Taussig Cancer Center [HTML]
or [PPT]
End Points for Clinical Trials in Primary
Treatment (Neoadjuvant and Adjuvant) of MO Disease and Hormone
Sensitive M1 Disease
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Hormone Sensitive Prostate Cancer; Registration
Trial Endpoints, Donna Griebel, M.D., FDA [HTML]
or [PPT]
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End points for clinical trials in early prostate
cancer: PSA-progression after radical prostatectomy, Peter Scardino [HTML] or [PPT]
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Evidence Supporting a PSA (t) End Point as Proof
of Clinical Efficacy, Anthony
D'Amico, M.D., Ph.D., Harvard Medical School [HTML] or [PPT]
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Can Biochemical Failure (ASTRO Definition) Be
Used As A Surrogate Endpoint For Prostate Cancer Survival In
Phase III Localized Prostate Cancer Clinical Trials? Analysis Of
RTOG Protocol 92-02 , Howard Sandler, M.D., University of
Michigan [HTML] or
[PPT]
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Clinical Trial Experiences in Early Prostate
Cancer, Kevin Carroll, MSc, FRSS, AstraZeneca
Pharmaceuticals [HTML] or [PPT]
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Examination of End Points in Advanced Disease
(D2) - Casodex Experience, Laurence Collette (presentation not
yet available)
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Correlation of PSA Endpoints with Overall
Survival in Men with Hormone-Naive D2 Prostate Cancer: Southwest
Oncology Group Study S8894,
Cathy Tangen, Fred Hutchinson Cancer Research Center [HTML] or [PPT]
Tuesday, June 22, 2004
Hormone Refractory Disease (MO with PSA
Rising Post Hormone Therapy and M1)
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Hormone Refractory Prostate Cancer End points to
measure safety and efficacy of treatment of advanced disease A
regulatory perspective, Bhupinder Mann, MBBS, FDA [HTML]
or [PPT]
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Clinical Trials Endpoints, Mario Eisenberger,
Johns Hopkins University
[HTML] or [PPT]
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Disease progression endpoints in hormone
refractory prostate cancer: experience with the endothelin
receptor antagonist, atrasentan, Perry Nisen, M.D., Ph.D.,
Abbott Laboratories [HTML] or [PPT]
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PSA Response: A Surrogate for Overall Survival?
Analysis of TAX 327 , Martin Roessner, M.S., Aventis. [HTML]
or [PPT]
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Three Month Change in PSA as a Surrogate
Endpoint for Mortality in Advanced Hormone-Refractory Prostate
Cancer: Data From Southwest Oncology Group Study 99-16, Daniel Petrylak,
M.D., Columbia University [HTML] or [PPT]
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Date created: July 1, 2004, Updated October 18,
2004  |
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