SWOG clinical trial number
SWOG-9346

Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III

Closed
Phase
Accrual
88%
Published
Abbreviated Title
Advanced Prostate
Activated
05/15/1995
Closed
09/01/2008
Participants
NCORP, Members, UCOP, Medical Oncologists, Surgeons, Pathologists, ECOG, CALGB, NCIC-CTG, EPP, EORTC, Affiliates

Research committees

Genitourinary Cancer

Treatment

Bicalutamide Goserelin Acetate

Eligibility Criteria Expand/Collapse

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

Publication Information Expand/Collapse

2018

Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials

M Chavez-MacGregor;J Unger;A Moseley;S Ramsey;DL Hershman Cancer Apr 15;124(8):1760-1769; Jan 25 [Epub ahead of print]

PMid: PMID29370458 | PMC number: PMC5963502

The association between ASCO Value framework and scientific and clinical impact of SWOG phase III clinical trials

V Nghiem;R Vaidya;M Banegas;D Hershman;J Unger AcademyHealth Annual Research Meeting (June 23-26, 2018, Seattle, WA), poster

Survival by Hispanic Ethnicity Among Cancer Patients participating in SWOG Clinical Trials

A Moseley;M Chavez-MacGregor;J Unger;S Ramsey;D Hershman Society for Clinical Trials Annual Meeting (May 20-23 2018, Portland, OR), oral presentation

2017

Association between body mass index and cancer survival in a pooled analysis of 22 clinical trials

H Greenlee;J Unger;M Leblanc;S Ramsey;D Hershman Cancer Epidemiology Biomarkers & Prevention 2017 Jan;26(1):21-29; 2016 Dec 16. [Epub ahead of print]

PMid: PMID27986655 | PMC number: PMC5370550

2016

Adverse health events following intermittent and continuous androgen deprivation in metastatic prostate cancer patients

D Hershman;J Unger;JD Wright;SD Ramsey;C Till;C Tangen;W Barlow;C Blanke;IM Thompson;M Hussain JAMA Oncology Apr;2(4):453-461

PMid: PMID26720308 | PMC number: PMC4852142

Evaluating intermittent androgen deprivation therapy phase III clinical trials: “The devil is in the details”

M Hussain;C Tangen;C Higano;N Vogelzang;IM Thompson Journal of Clinical Oncology Jan 20;34(3):280-285

PMid: PMID26552421 | PMC number: PMC5242560

2015

Long term consequences of intermittent and continuous androgen deprivation in patients with metastatic prostate cancer

D Hershman;JM Unger;J Wright;S Ramsey;C Till;C Tangen;W Barlow;C Blanke;IM Thompson;M Hussain Journal of Clinical Oncology 33:5s (suppl; abstr 5008); American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), oral presentation;

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

Improved overall survival trends of men with newly diagnosed M1 prostate cancer: a SWOG phase III trial experience (S8494, S8894 & S9346)

C Tangen;M Hussain;C Higano;M Eisenberger;E Small;G Wilding;B Donnelly;PM Venner;P Schellhammer;ED Crawford;N Vogelzang;I Powell;IM Thompson Journal of Urology 188(4):1164-1169;

PMid: PMID22921015 | PMC number: PMC3481164

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;

Preliminary quality of life outcomes for SWOG-9346: intermittent androgen deprivation in patients with hormone sensitive metastatic prostate cancer (HSM1PC), phase III

C Moinpour;DL Berry;B Ely;C Tangen;C Higano;J Picus;P Schellhammer;E Skinner;M Cher;I Thompson;M Hussain Journal of Clinical Oncology 30 (suppl; abstr 4571); American Society of Clinical Oncology 2012 Annual Meeting (June 1-5, 2012, Chicago, IL), poster discussion;

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)

Other Clinical Trials

SWOG Clinical Trial Number
SWOG-7303
SWOG Clinical Trial Number
SWOG-8221 (INT-0007)

Treatment of Advanced Bladder Cancer with Preoperative Irradiation and Radical Cystectomy versus Radical Cystectomy Alone

Research Committee(s)
Genitourinary Cancer
Activated
10/29/1982
Closed
11/15/1989
Accrual
81%
Closed
Published
SWOG Clinical Trial Number
SWOG-8216/38

Comparison of BCG Immunotherapy and Adriamycin for Superficial Bladder Cancer

Research Committee(s)
Genitourinary Cancer
Activated
12/01/1982
Closed
01/15/1987
Closed
Phase
III
Published