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Forthcoming Protocol
Combining Active Surveillance And Biomarker Analysis
(June 2008)
With a planned activation in mid-2008, a
protocol jointly sponsored by the Canary Foundation and National Cancer
Institute will be offered "with a joint goal of reducing over-treatment
by identifying aggressive versus passive tumors." As a succinct
introduction to this protocol, the introductory paragraph from the
Canary Foundation Web site press release is reprinted here (http://www.canaryfoundation.org/news-050108)
and the full release is well worth a read.
"Canary Foundation
and the National Cancer Institute Launch New Prostate Cancer Study”
Partnership aims to
reduce over-treatment of prostate cancer by identifying and validating
biomarkers of high-risk prostate cancer
San Jose, Calif. — May
1, 2008 — The Canary Foundation, a nonprofit organization that funds
research in early cancer detection, and the National Cancer Institute's
Early Detection Research Network (EDRN), jointly announced today that
the two organizations are forming a partnership for the purpose of
identifying and validating biomarkers of high-risk prostate cancer
within the context of an active surveillance study. Six of the nation's
leading medical research institutions will be participating in this
study, which will be ready to enroll patients this summer."
The collaboration is
headed in the Seattle area by Daniel Lin, MD, University of Washington,
and includes major investigators from Stanford University, Fred
Hutchinson Cancer Research Center, and the Universities of California,
British Columbia, and Texas Health Science Center, San Antonio.
Information about the
general outlines of the protocol was kindly made available by Dr. Lin
and will be briefly summarized:
The protocol schema is
a "prospective active surveillance study with selective intervention in
patients with previously untreated, clinically localized prostate
cancer," cT1-2, NX or NO, MX or MO. An ECOG Performance Status of 0 or 1
is required.
Intervention will be
prompted by biochemical progression, grade or volume progression, or
clinical progression.
The study participants
will be monitored for rates of radical intervention, clinical recurrence
and progression, disease specific survival, and overall survival.
The study will acquire
and bank serum, urine, and tissue specimens for biomarker studies and
for the creation of tissue microarrays. "The primary objective of this
repository is to discover and validate biomarkers predicting aggressive
disease, with emphasis on validation." [Evaluation for TMPRSS2-ERG and
PCA3 are under consideration as important biomarkers in this protocol
and are discussed in this PCa Commentary under "Molecular Diagnostics.]
Patients will undergo
serial PSA measurements every 3 months and repeat biopsies at 6-12
months from study entry, then every two years, or "for cause."
For information about
the initiation of the protocol and registration of patients call Lisa
Newcomb as contact for the UW (206-667-1946).
Widespread PSA testing has resulted in a
large scale migration in the clinical presentation of prostate cancer to
increased early detection of tumors at lower stage and grade.
Accompanying this shift has been a judicious acceptance of, and
increased recommendation for, an initial management strategy of active
surveillance with delayed intervention. This forthcoming protocol will
very likely help to define those men who are the best candidates for
this option.
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