Effectiveness of zoledronic acid for the prevention of bone metastases in high risk prostate cancer patients: A randomised, open label, multicenter study of the European Association of Urology (EAU) in cooperation with the Scandinavian Prostate Cancer Group (SPCG) and the Arbeitsgemeinschaft Urologische Onkologie (AUO). An initial report of the “ZEUS” study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14644-14644 ◽  
Author(s):  
W. Witjes ◽  
T. Tammela ◽  
M. Wirth
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
High Risk ◽  
Bone Metastases ◽  
Hormonal Treatment ◽  
European Study ◽  
Open Label ◽  
Curative Intent ◽  
Initial Report ◽  
High Risk Prostate Cancer

14644 Background: Patients with advanced prostate cancer (PC) are at high risk of developing bone metastases resulting in clinically significant skeletal morbidity and debilitating bone pain. Zoledronic acid (ZA) significantly reduced the incidence and delayed the onset of skeletal complications and provided durable pain reduction compared with placebo in patients with PC metastatic to bone. Methods: We started a European study investigating the effect of ZA in the prevention of PC bone metastases in patients with high risk PC. This prospective, multi-centre, randomised, open-label study, the ZA EUropean Study (ZEUS), aims at randomising 1300 patients within 3 years in 13 European countries and Turkey. Patients are randomised for standard PC therapy plus 4 mg ZA intravenously every 3 months for a period of 48 months or standard PC therapy alone. Results: Presently, we have randomised 484 patients with a mean age of 67 years (range 45–86) in 13 countries. All patients had at least one of the following high risk prognostic factors: 281 (58%) patients had a PSA ≥ 20 ng/ml, 140 (29%) patients had lymphnode positive disease and 286 (59%) patients had a Gleason of 8–10. 124 (26%) patients had a PSA ≥ 20 ng/ml and a Gleason of 8–10; 60 (12%) patients had a PSA ≥ 20 ng/ml and N1 disease and 64 (13%) patients had a Gleason of 8–10 and N1 disease. 244 (50%) patients underwent a prior prostatectomy or radiotherapy with curative intent and 303 (63%) patients received hormonal treatment. The randomisation arms were equally distributed amongst prognostic groups, centres and countries. Conclusions: The ZEUS study is designed to evaluate if ZA can contribute in preventing or delaying bone metastases in high risk PC patients. Presently, the majority (59%) of patients have a Gleason of 8–10 or a PSA ≥ 20 ng/ml (58%) and they receive hormonal treatment (63%). Half (50%) of the patients underwent a prior prostatectomy or radiotherapy with curative intent. This is representative for the PC population that is at high risk for developing bone metastases. No significant financial relationships to disclose.

Prevention of Bone Metastases in Patients with High-risk Nonmetastatic Prostate Cancer Treated with Zoledronic Acid: Efficacy and Safety Results of the Zometa European Study (ZEUS)

2015 ◽  
Vol 67 (3) ◽  
pp. 482-491 ◽  
Author(s):  
Manfred Wirth ◽  
Teuvo Tammela ◽  
Virgilio Cicalese ◽  
Francisco Gomez Veiga ◽  
Karl Delaere ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
High Risk ◽  
Bone Metastases ◽  
Efficacy And Safety ◽  
European Study

The role of intravenous zoledronic acid in the management of high-risk prostate cancer

2003 ◽  
Vol 13 (2) ◽  
pp. 133-135 ◽  
Author(s):  
Scott M. Gilbert ◽  
Carl A. Olsson ◽  
Mitchell C. Benson ◽  
James M. McKiernan
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
High Risk ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer

MER-101–03, a multicenter, phase II study to compare MER-101 20mg tablets to intravenous zoledronic acid 4mg in prostate cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5161-5161
Author(s):  
C. McHugh ◽  
K. Madigan ◽  
A. Walsh ◽  
J. Fox ◽  
T. W. Leonard ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Cancer Patients ◽  
Phase Ii ◽  
Performance Status ◽  
Hormone Refractory Prostate Cancer ◽  
Open Label ◽  
Secondary Endpoints ◽  
Hormone Refractory

5161 Background: The primary objective of this study is to examine the pharmacodynamic effects of two different regimens of zoledronic acid, Orazol 20 mg tablets versus Zometa 4mg IV infusion once-monthly therapy on biomarkers in male bisphosphonate-naïve hormone-refractory prostate cancer patients. Methods: The study is an open-label, multi-center phase II clinical trial to compare oral Orazol 20 mg tablets weekly, to infusions of intravenous Zometa 4mg monthly, in males with hormone-refractory prostate cancer, bone metastases, and no prior bisphosphonate treatment. Patients were assigned into one of three cohorts. The three treatments administered were IV Zometa, 4 mg, 15 minute infusion, Day 0 and Day 28; Orazol po, 20 mg, Days 0, 7, 14, 21, 28, 35, 42, and 49; and Orazol po, 20 mg, Days 0, 1, 2, 3, 28, 35, 42, and 49. The study population consisted of men with hormone refractory prostate cancer as evidenced by history of rising PSA levels (last 2 of 3 PSA levels must be above nadir), who are bisphosphonate-naive, and have radiographically-confirmed bone metastases. Efficacy assessments: The primary endpoints are the assessment of response of four biomarkers, urinary NTX, serum CTX, serum bone specific alkaline phosphatase, and serum calcium on days -7, 0, 7, 14, 21, 28, 35, 42, 49, and 56. Secondary endpoints are assessments of performance and pain scores based on ECOG performance status, BPI, and analgesic use. Safety assessments include physical examinations, vital signs and body weight, hematology panel, urinalysis, and blood chemistry panel. Results: The results demonstrated a rapid decrease for all four biomarkers. This decrease was seen at seven days, and was sustained throughout the study. There were no statistically significant differences between any of the treatments in the primary and secondary endpoints. Conclusions: From the results of MER-101–03, Orazol weekly therapy appears to be as effective as Zometa, based on the biomarkers analyzed. Orazol offers a substantial improvement in therapy over IV infusion for patients, with efficacy that is at least comparable based on the results obtained here. No significant financial relationships to disclose.

Association between primary surgery and all-cause mortality among elderly patients with high-risk prostate cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. e576-e576
Author(s):  
Sumedha Chhatre ◽  
David Inkoo Lee ◽  
Doyeong Yu ◽  
S. Bruce Malkowicz ◽  
Ravishankar Jayadevappa
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
High Risk ◽  
Propensity Score ◽  
Curative Intent ◽  
High Risk Prostate Cancer ◽  
Primary Surgery ◽  
All Cause Mortality ◽  
Risk Prostate Cancer

e576 Background: To determine the five year survival impact of primary surgery compared to radiation therapy in older men with high risk prostate cancer. Methods: This was a population-based cohort study using Surveillance, Epidemiology, and End Results (SEER)-Medicare patients 66 years or older, diagnosed for prostate cancer between 2004 and 2008. High-risk prostate cancer was identified as Gleason score of ≥ 8, or clinical stage T3a. Treatments studied were definitive local (curative intent) therapy (surgery or radiation therapy) within 180 days of prostate cancer diagnosis. The two treatment groups were retrospectively followed for one-year pre and five years post diagnosis. Main outcome measure was five-year all-cause mortality and cancer specific mortality. Sequential Cox regression was used to assess the hazard of mortality associated with surgery, compared to radiation therapy, after adjusting for socio-demographic variables, variables and propensity score. Results: We identified a cohort of 24,838 men newly diagnosed for high-risk for prostate cancer between 2004 and 2008. Forty-seven percent of these had surgery (n = 11,696) as well as radiation therapy (n = 11,724) as a primary treatment with curative intent within 180 days of diagnosis. Mean age at diagnosis of radiation therapy group was higher compared to surgery group (73.5, sd = 5.3 vs. 70.3, sd = 4.9; p = 0.020). Radiation group had higher comorbidity compared to surgery group (37% vs. 26%, p = 0.0316). Unadjusted all-cause mortality comparison over five years of follow-up showed that surgery treatment was associated with lower mortality (HR = 0.58, CI = 0.54, 0.62). After adjusting for propensity score, the hazard of all-cause five year mortality remained lower for surgery compared to radiation therapy (HR = 0.86, CI = 0.78, 9.4). Conclusions: Over a five-year follow-up, primary surgery was associated with improved survival compared to radiation therapy in high-risk prostate cancer patients. Longer follow-up is needed to determine if the survival advantage of surgery will persist as well as factors contributing to the difference in survival.

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