SWOG clinical trial number
S9917
L-Selenium-Based Chemoprevention of Prostate Cancer Among Men with High Grade Prostatic Intraepithelial Neoplasia
Abbreviated Title
GU/Prostate (HGPIN)
Participants
NCORP,
Members, UCOP, Medical Oncologists, Surgeons, Pathologists, ECOG, CALGB, VA Special Member Institutions
Treatment
Selenium
Surgery
Pt must be age 40 or older. Pt must have had a DRE and a biopsy of the prostate w/ suggested TRUS guidance (required if fewer than 6 cores obtained) that documents High Grade Prostatic Intraepithelial Neoplasia (High Grade PIN or HGPIN) with no evidence of cancer. The biopsy must either: a) yielded < 10 cores w/in 2 yrs prior to reg or the biopsy yielded > 10 cores but was more than 6 months but within 2 yrs prior to reg, or b) yielded 10 or more cores w/in 6 months prior to reg. Material outlined in Section 12.0 of the protocol must be submitted for central review w/in 14 days of registration. Pt must have a PSA <= 10 ng/ml. Pt must have AUA symptom score of less than 20. Pt must have PS of 0 or 1. Pt must agree to stop taking any dietary supplements which contain >/= 50 mcg/day of selenium w/in 30 days prior to registration. Pt must agree not to take supplements containing 50 mcg or more of selenium while on study. Pt must not be taking finasteride or any other androgen suppressor.
CANCER CONTROL CREDIT: 1.0 and 0.3 Follow-up For Each Year Beyond The First
TREATMENT CREDIT: 0.0
2011
Selenium supplementation and prostate cancer among men with high grade prostatic intraepithelial neoplasia: SWOG-directed intergroup trial S9917 [PMID21896650; PMC3208719]
JR Marshall;C Tangen;W Sakr;DP Wood;D Berry;E Klein;S Lippman;H Parnes;D Alberts;D Jarrard;WR Lee;JM Gaziano;ED Crawford;B Ely;M Ray;W Davis;L Minasian;IM Thompson Cancer Prevention Research 4(11):1761-1769;
2010
Southwest Oncology Group (SWOG) trial S9917: Randomized phase 3 trial of selenium supplementation to prevent prostate cancer among men with high grade prostatic intraepithelial neoplasia (HGPIN)
J Marshall;C Tangen;W Sakr;DP Wood;S Lippman;D Jarrad;DS Alberts;DL Berry;ED Crawford;IM Thompson American Urological Association Annual Meeting; late breaking, oral
2006
Design and progress of a trial of selenium to prevent prostate cancer among men with high-grade prostatic intraepithelial neoplasia
JR Marshall;W Sakr;D Wood;D Berry;C Tangen;F Parker;I Thompson;SM Lippman;R Lieberman;D Alberts;D Jarrard;C Coltman;P Greenwald;L Minasian;ED Crawford Cancer Epidemiol Biomarkers Prev 15(8):1479-1484
2004
Low rate of confirming prostate cancer on repeat biopsies following diagnosis of high grade prostatic intraepithelial neoplasia. Preliminary analysis of Southwest Oncology Group study S9917.
WA Sakr;JR Faulkner;D Wood;I Thompson;D Crawford;S Lippman;C Coltman;J Marshall Proc of the American Association of Cancer Research 45:305 (#1333)
