SWOG clinical trial number
S0925

A Randomized Phase II Study of Androgen Deprivation Combined with IMC-A12 Versus Androgen Deprivation Alone for Patients with New Hormone-Sensitive Metastatic Prostate Cancer

Closed
Phase
II
Accrual
100%
Published
Abbreviated Title
New Hormone-Sensitive Metastatic PCa, Androgen Deprivation +/- IMC-A12, Ph II
Activated
12/15/2010
Closed
12/01/2012
Participants
NCORP, Members, Medical Oncologists, Surgeons, Affiliates

Research committees

Genitourinary Cancer

Treatment

Bicalutamide Leuprolide Acetate Goserelin Acetate IMC-A12

Eligibility Criteria Expand/Collapse

Pt must have histologic or cytologic diagnosis of prostate adenocarcinoma which is metastatic (M1) as evidenced by soft tissue and/or bony mets PRIOR to ADT initiation. If no formal bx report, pt eligible if PSA > 20 and at least 3 definitive mets seen on scan. Pt w/measurable disease must have radiographic assessment w/in 28 days prior to reg. Non-measurable disease assessed w/in 56 days. PSA >/= 5 w/in 90 days. No known brain mets. No more than 30 days of prior medical castration for met PCa. Prior ADT ok if rec'd w/curative intent in neoadj, concurrent, and/or adj fashion at least 2 years elapsed since completion of ADT. If method of castration LHRH agonists, pt must be willing to continue LHRH agonists and add bicalutamide for CAD. If pt was on a different antiandrogen, must be willing to switch to bicalutamide. Pts must not have rec'd bilateral orchiectomy. Pt must not have rec'd or be planning to receive LHRH antagonists (Degarelix) however if LHRH antagonist initiated w/in 30 days and pt willing to switch to LHRH agonist w/bicalutamide, pt may be enrolled in late induction group. Pt who hasn't already started AD must be offered opportunity to participate in trans med studies. No prior cytotoxic chemo for met PCa. Prior chemo w/curative intent in neoadj or adj setting ok. No prior tx w/agents that directly inhibit IGF or IGFRs. No prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionuclide tx w/in 28 days. Prior RT or biologic tx no excluded by Section 5.5, 5.7 or 5.8 allowed, but 28 days must have elapsed since completion and pt must have recovered from all side effects. Prior surgery allowed, but for all major surgeries at least 28 days must have elapsed and pt recovered. Leukocytes >/= 3000, ANC >/= 1500, HGB >/= 9, PLTS >/= 100,000, Bili </= 1.5 x IULN unless documented Gilbert's disease, SGOT and SGPT </= 3 x IULN or </= 5 x IULN if liver mets present, creatinine </= 2 x IULN or calc CrCl > 40, INR </= 1.5, PTT no more than 5 seconds abover the IULN w/in 28 days prior to reg. Pts req'g full-dose anticoagulation are eligible if on stable dose and parameters w/in therapeutic range (INR 2-3). HgA1C </= 7 and fasting glucose of < 160 or below IULN w/in 14 days. Diabetic pts who meet this criterion must be on stable dietary or therapeutic regimen. No hx of symptomatic CHF or known LVEF >/= 10% below LLN. If LV dysfunction suspected, a MUGA or echo should be obtained w/in 90 days prior to reg. No hx of allergic reaction attributed to compounds of similar chemical or biologic composition to IMC-A12. No prior chimerized or murine monoclonal antibody therapy. Zubrod PS 0-2 or 3 if from bone pain only. No HIV positivity requiring antiretroviral therapy. No plans for concurrent chemo, hormonal, radio, immuno, or other type of therapy for tx of Ca. Concurrent bone targeting agents w/out PSA effect (denosumab or zoledronic acid) ok. No plans to receive concurrent five-alpha reductase inhibitors, ketoconazole, diethylstilbestrol/DES, or other estrogen-based therapy. No other prior malignancy. Agreed to use effective contraceptive method while rec'g tx and for at least 3 mos after prot tx ends.

Publication Information Expand/Collapse

2020

Survival outcomes and risk group validation from SWOG S0925, a randomized phase II study of cixutumumab in new metastatic hormone-sensitive prostate cancer

R Wong;M Duong;C Tangen;N Agarwal;H Cheng;N Vogelzang;M Hussain;I Thompson;D Quinn;E Yu Prostate Cancer and Prostatic Disease Feb 13. doi: 10.1038/s41391-020-0210-x. [Epub ahead of print]

PMid: PMID32055002

2018

Circulating microRNAs and treatment response in SWOG S0925, a randomized phase II study of androgen deprivation combined with cixutumumab versus androgen deprivation alone for patients with new metastatic hormone-sensitive prostate cancer

H Cheng;M Plets;H Li;C Higano;C Tangen;N Agarwal;N Vogelzang;M Hussain;I Thompson;M Tewari;EY Yu Prostate Feb;78(2):121-127

PMid: PMID29105802 | PMC number: PMC5728359

2015

SWOG S0925: A randomized phase 2 study of androgen deprivation combined with cixutumumab versus androgen deprivation alone in patients with new metastatic hormone-sensitive prostate cancer

E Yu;H Li;C Higano;N Agarwal;SK Pal;A Alva;E Heath;E Lam;S Gupta;M Lilly;Y Inoue;K Chi;N Vogelzang;DI Quinn;H Cheng;SR Plymate;M Hussain;C Tangen;IM Thompson Journal of Clinical Oncology May 10;33(14):1601-1608

PMid: PMID25847934 | PMC number: PMC4417730

2014

SWOG S0925: A randomized phase 2 study of androgen deprivation combined with cixutumumab (IMC-A12) versus androgen deprivation alone for patients with new metastatic castration-sensitive prostate cancer

EY Yu;CM Tangen;C Higano;N Agarwal;SK Pal;A Alva;E Heath;ET Lam;S Gupta;M Lilly;Y Inoue;KN Chi;NJ Vogelzang;DI Quinn;H Li;H Cheng;H Plymate;MHA Hussain;IM Thompson Journal of Clinical Oncology 32:5s (suppl; abstr 5006); ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), oral session;

Comparison of plasma microRNAs with CTCs and PSA in patients treated on SWOG S0925, a randomized phase II study of androgen deprivation combined with cixutumumab versus androgen deprivation alone for patients with new metastatic hormone-sensitive prostate cancer

HH Cheng;H Li;C Higano;C Tangen;N Agarwal;J Yan;N Vogelzang;MHA Hussain;IM Thompson;M Tewari;EY Yu Journal of Clinical Oncology 32:5s (suppl; abstr 5017); ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), poster highlights session;

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Research Committee(s)
Genitourinary Cancer
Activated
04/19/2019
Accrual
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Open
Phase
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