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Time to second prostate specific antigen (PSA) failure is a surrogate endpoint for prostate cancer death in prospective trials of therapy for localized disease

Abstract

Purpose In assessing the efficacy of the competing curative therapies for prostate cancer the most relevant endpoint is cancer specific death. Due to the long natural history of the disease and the use of salvage androgen suppression prospective trials need to mature for at least a decade to provide meaningful results. An endpoint that predicted for cancer death with high probability would allow more rapid completion of prospective studies, hopefully before the tested therapies become outdated. Materials and methods 202 patients entered into a single institution prospective randomized study for T3-4 prostate cancer between 1982 and 1992 were evaluated. All received radical irradiation to either a standard dose of 67.2Gy or a higher dose of 75.6Gy (the latter employing a proton beam boost). 76 men have received androgen suppression or orchiectomy for salvage following relapse (median follow-up 6.9 years). Of this group 35 experienced a second relapse heralded by a rise in the serum PSA. Second failure was scored on the date that the serum PSA rose to greater than 10% above the post-androgen suppression nadir. Kaplan-Meier analysis was made of survival from the time of second PSA failure and the cause of death established in all patients who subsequently  More>>
Publication Date:
Jul 01, 1995
Product Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 32; Journal Issue: 971; Other Information: Copyright (c) 1995 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); PBD: 1995
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ANDROGENS; ANTIGENS; BIOLOGICAL INDICATORS; CARCINOMAS; HORMONES; PROSTATE; RADIATION DOSES; RADIOTHERAPY; SURGERY; SURVIVAL TIME
OSTI ID:
20420692
Country of Origin:
United States
Language:
English
Other Identifying Numbers:
Journal ID: ISSN 0360-3016; IOBPD3; TRN: US03R1930005097
Submitting Site:
INIS
Size:
page(s) 229
Announcement Date:

Citation Formats

Zietman, A L, Dallow, K C, Shipley, W U, Heney, N M, and McManus, P L. Time to second prostate specific antigen (PSA) failure is a surrogate endpoint for prostate cancer death in prospective trials of therapy for localized disease. United States: N. p., 1995. Web. doi:10.1016/0360-3016(95)97838-R.
Zietman, A L, Dallow, K C, Shipley, W U, Heney, N M, & McManus, P L. Time to second prostate specific antigen (PSA) failure is a surrogate endpoint for prostate cancer death in prospective trials of therapy for localized disease. United States. doi:10.1016/0360-3016(95)97838-R.
Zietman, A L, Dallow, K C, Shipley, W U, Heney, N M, and McManus, P L. 1995. "Time to second prostate specific antigen (PSA) failure is a surrogate endpoint for prostate cancer death in prospective trials of therapy for localized disease." United States. doi:10.1016/0360-3016(95)97838-R. https://www.osti.gov/servlets/purl/10.1016/0360-3016(95)97838-R.
@misc{etde_20420692,
title = {Time to second prostate specific antigen (PSA) failure is a surrogate endpoint for prostate cancer death in prospective trials of therapy for localized disease}
author = {Zietman, A L, Dallow, K C, Shipley, W U, Heney, N M, and McManus, P L}
abstractNote = {Purpose In assessing the efficacy of the competing curative therapies for prostate cancer the most relevant endpoint is cancer specific death. Due to the long natural history of the disease and the use of salvage androgen suppression prospective trials need to mature for at least a decade to provide meaningful results. An endpoint that predicted for cancer death with high probability would allow more rapid completion of prospective studies, hopefully before the tested therapies become outdated. Materials and methods 202 patients entered into a single institution prospective randomized study for T3-4 prostate cancer between 1982 and 1992 were evaluated. All received radical irradiation to either a standard dose of 67.2Gy or a higher dose of 75.6Gy (the latter employing a proton beam boost). 76 men have received androgen suppression or orchiectomy for salvage following relapse (median follow-up 6.9 years). Of this group 35 experienced a second relapse heralded by a rise in the serum PSA. Second failure was scored on the date that the serum PSA rose to greater than 10% above the post-androgen suppression nadir. Kaplan-Meier analysis was made of survival from the time of second PSA failure and the cause of death established in all patients who subsequently died. Results The median duration of response to hormone therapy following first failure was 27.2 months. The actuarial survival from the time of second biochemical relapse was 93%, 66%, 35%, and 0% at 1, 2, 3, and 4 years respectively (50% at 32 months). 16 patients have so far died after second failure all from causes related to their prostate cancer. Conclusion Second PSA failure appears to be a secure surrogate for impending prostate cancer death. Its use as an endpoint in prospective studies should allow earlier reporting by 2 - 3 years.}
doi = {10.1016/0360-3016(95)97838-R}
journal = {International Journal of Radiation Oncology, Biology and Physics}
issue = {971}
volume = {32}
journal type = {AC}
place = {United States}
year = {1995}
month = {Jul}
}