SWOG clinical trial number
SWOG-9346
Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III
Abbreviated Title
Advanced Prostate
Participants
NCORP,
Members, UCOP, Medical Oncologists, Surgeons, Pathologists, ECOG, CALGB, NCIC-CTG, EPP, EORTC,
Affiliates
Treatment
Bicalutamide
Goserelin Acetate
Pts must have hist. or cyto. prov. adenoca, Stage D2. Pts with possible second primaries allowed only if metastatic disease histologically confirmed. Stage D2 pts meeting the above criteria and who have already begun the use of CAD are eligible for a late induction registration to this study if: 1) LHRH agonist and antiandrogen therapy was initiated within the previous 6 mos., 2) the effectiveness of the LHRH agonist depot would not extend beyond 8 mos. since the initiation of CAD and 3) PSA values and all other requirements per the Study Calendar for Mo.6 are or will be available. (See Section 5.2) Pts on LHRH agonist only (monotherapy) are eligible for late induction registration provided that they were treated initially with LHRH agonist plus antiandrogen to prevent flare and meet the following criteria: 1) First dose of LHRH agonist must be within 6 months prior to registration, 2) the effectiveness of the current depot LHRH agonist would not extend beyond 8 months since initiation of treatment with CAD, 3) PSA values from and all other requirements per the Study Calendar for Mo. 6 are or will be available, 4) Pts must be placed on CAD when registered. (See Section 5.3). PSA > or = 5 ng/ml, prior neoadjuvant or adjuvant HT allowed, only if received <= 4 mo.(orch. excluded), prior finasteride allowed if given for BPH <= 9 mo., both neoadjuvant or adjuvant HT or finasteride must be discontinued >1 yr prior to reg., no concomitant chemo, BRM, HT or RT, pts with acute cord compression are not eligible, SGOT <= 2 X IULN, Bilirubin <= 2 X IULN, pts. must meet PSA norm. criterion for randomization at mo. 8., randomization will occur only if both the mo. 6 and mo. 7 PSA results are stable or declining (PSA <= 4.0 ng/ml on previous two months). (See protocol for complete description). All SWOG, ECOG and CALGB pts registered for Early Induction on or after 9/1/04 must agree to participate in the correlative studies (see protocol Section 5.16).
CANCER CONTROL CREDIT: 0.5
TREATMENT CREDIT: 1.0
2014
Association between BMI at treatment initiation and cancer survival across multiple SWOG trials
H Greenlee;J Unger;M Leblanc;D Hershman AACR Research International Conference on Frontiers on Cancer Research Prevention (Sept 28-Oct 1, 2014, New Orleans, LA; poster
2013
Intermittent versus continuous androgen deprivation in prostate cancer
M Hussain;C Tangen;DL Berry;C Higano;ED Crawford;G Liu;G Wilding;S Prescott;S Kanaga Sundaram;EJ Small;NA Dawson;B Donnelly;P Venner;UN Vaishampayan;PL Schellhammer;DI Quinn;D Raghavan;B Ely;C Moinpour;NJ Vogelzang;IM Thompson New England Journal of Medicine, Apr 4; 368(14):1314-1325;
PMid: PMID23550669 | PMC number: PMC3682658
2012
Intermittent (IAD) vs Continuous Androgen Deprivation (CAD) in Hormone Sensitive Metastatic Prostate Cancer (HSM1PC) Patients (pts): Results of S9346 (INT-0162) an International Phase III trial
M Hussain;C Tangen;C Higano;E Crawford;G Liu;G Wilding;S Prescott;A Akdas;E Small;N Dawson;B Donnelly;P Venner;U Vaishampayan;P Schellhammer;D Quinn;D Raghavan;N Vogelzang;IM Thompson J Clin Oncol 30 (suppl; abstr 4); American Society of Clinical Oncology 2012 Annual Meeting (June 1-5, 2012, Chicago, IL), oral, plenary session;
2010
Improved overall survival (OS) of patients (pts) with new metastatic prostate cancer (PCa): better efficacy or stage migration? Data from SWOG: S9346 and 8894
M Hussain;C Tangen;CS Higano;M Eisenberger;EJ Small;G Wilding;BJ Donnelly;D McLeod;ED Crawford;IM Thompson Proceedings of the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium, abst. 30; poster
2009
Prostate-specific antigen progression (PSA-P) predicts overall survival (OS) in patients with metastatic prostate cancer: data from Southwest Oncology Group (SWOG) trials 9346 (INT 0162) and 9916 [PMC2684851; PMID19380444]
M Hussain;B Goldman;C Tangen;CS Higano;DP Petrylak;G Wilding;A Akdas;EJ Small;BJ Donnelly;L Collette;PA Burch;RS DiPaola;ED Crawford Journal of Clinical Oncology 27(15):2450-2456
Cooperative group trials - Southwest Oncology Group (SWOG) innovations in advanced prostate cancer [PMID21085622; PMC2981166]
TB Dorff;C Tangen;ED Crawford;DP Petrylak;CS Higano;D Raghavan;DI Quinn;NJ Vogelzang;IM Thompson;MHA Hussain Therapeutic Advances in Medical Oncology 1(2):69-77;
2008
Prostate-specific antigen progression (PSA-P) predicts overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916.
B Goldman;M Hussain;C Tangen;C Higano;DP Petrylak;NJ Vogelzang;ED Crawford Journal of Clinical Oncology 26(15s):253s, #5015
Use of prostate-specific antigen progression (PSA-P) to predict overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916
MHA Hussain;B Goldman;CM Tangen;C Higano;DP Petrylak;ED Crawford Journal of Clinical Oncology 26(15S):253s, #5015
Prostate specific antigen progression (PSA-P) as a predictor of overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916
B Goldman;M Hussain;C Tangen;C Higano;DP Petrylak;N Vogelzang;ED Crawford Proceedings of the American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, abst. 165
2006
Absolute PSA value after androgen deprivation (AD) is a strong independent predictor of survival in new metastatic (D2) prostate cancer (PCa): Data from Soutwest Oncology Group trial 9346 (INT-0162)
M Hussain;C Tangen;P Schellhammer;ED Crawford;C Higano;G Wilding;A Akdas;EJ Small;B Donnelly;D Raghavan Proc of the ASCO, Journal of Clinical Oncology 24(18S):#4517
Absolute prostate-specific antigen value after androgen deprivation is a strong independent predictor of survival in new metastatic prostate cancer: data from Southwest Oncology Group trial 9346 (INT-0162)
M Hussain;CM Tangen;C Higano;PF Schellhammer;J Faulkner;ED Crawford;G Wilding;A Akdas;EJ Small;B Donnelly;G MacVicar;D Raghavan Journal of Clinical Oncology 24(24):3984-3990
2003
Determinants of prostate specific antigen (PSA) normalization in prostate cancer (PCa) patients (pts) treated with androgen deprivation (AD) on Southwest Oncology Group (SWOG) study 9346 (INT-0162).
CM Tangen;M Hussain;G Wilding;EJ Small;L Goldenberg;A Akdas;ED Crawford Proc of the American Society of Clinical Oncology 22:396(#1591)
