Open-label trial evaluating the safety and efficacy of zoledronic acid in preventing bone loss in patients with hormone-sensitive prostate cancer and bone metastases

Urology ◽  
2005 ◽  
Vol 66 (5) ◽  
pp. 1054-1059 ◽  
Author(s):  
Thomas J. Polascik ◽  
Robert W. Given ◽  
Charles Metzger ◽  
Sydney R. Julian ◽  
James C. Vestal ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Loss ◽  
Bone Metastases ◽  
Open Label ◽  
Safety And Efficacy ◽  
Hormone Sensitive ◽  
Open Label Trial

scholarly journals A Prospective, Multicenter, Open-label Trial of Zoledronic Acid in Patients with Hormone Refractory Prostate Cancer

2007 ◽  
Vol 48 (6) ◽  
pp. 1001 ◽  
Author(s):  
Sung Joon Hong ◽  
Kang Su Cho ◽  
Han Yong Choi ◽  
Hanjong Ahn ◽  
Choung-Soo Kim ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Hormone Refractory Prostate Cancer ◽  
Open Label ◽  
Open Label Trial ◽  
Hormone Refractory

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.

scholarly journals Randomized Controlled Trial of Early Zoledronic Acid in Men With Castration-Sensitive Prostate Cancer and Bone Metastases: Results of CALGB 90202 (Alliance)

2014 ◽  
Vol 32 (11) ◽  
pp. 1143-1150 ◽  
Author(s):  
Matthew R. Smith ◽  
Susan Halabi ◽  
Charles J. Ryan ◽  
Arif Hussain ◽  
Nicholas Vogelzang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Primary Analysis ◽  
Open Label ◽  
Castration Resistant

Purpose Zoledronic acid decreases the risk for skeletal-related events (SREs) in men with castration-resistant prostate cancer and bone metastases but its role earlier in the natural history of the disease is unknown. This phase III study evaluated the efficacy and safety of earlier treatment with zoledronic acid in men with castration-sensitive metastatic prostate cancer. Patients and Methods Men with castration-sensitive prostate cancer and bone metastases whose androgen-deprivation therapy was initiated within 6 months of study entry were randomly assigned in a blinded 1:1 ratio to receive zoledronic acid (4 mg intravenously every 4 weeks) or a placebo. After their disease progressed to castration-resistant status, all patients received open-label treatment with zoledronic acid. The primary end point was time to first SRE, defined as radiation to bone, clinical fracture, spinal cord compression, surgery to bone, or death as a result of prostate cancer. Target accrual was 680 patients. Primary analysis was planned after 470 SREs. The study was discontinued prematurely (645 patients; 299 SREs) after the corporate supporter withdrew study drug supply. Results Early zoledronic acid was not associated with increased time to first SRE. The median time to first SRE was 31.9 months in the zoledronic acid group (95% CI, 24.2 to 40.3) and 29.8 months in the placebo group (95% CI, 25.3 to 37.2; hazard ratio, 0.97; 95% CI, 0 to 1.17; one-sided stratified log-rank P = .39). Overall survival was similar between the groups (hazard ratio, 0.88; 95% CI, 0.70 to 1.12; P = .29). Rates of adverse events were similar between the groups. Conclusion In men with castration-sensitive prostate cancer and bone metastases, early treatment with zoledronic acid was not associated with lower risk for SREs.

Zoledronic acid (Z) as palliative treatment in cancer patients with bone metastases: Interim results of a prospective, open-label trial

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 8140-8140
Author(s):  
A. Kretzschmar ◽  
T. Wiegel ◽  
S. E. Al-Batran ◽  
H. F. Hinrichs ◽  
M. Kindler ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
Bone Metastases ◽  
Cancer Patients ◽  
Palliative Treatment ◽  
Open Label ◽  
Open Label Trial

Zoledronic acid (Z) as palliative treatment in cancer patients with bone metastases: Interim results of a prospective, open-label trial

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 8140-8140 ◽  
Author(s):  
A. Kretzschmar ◽  
T. Wiegel ◽  
S. E. Al-Batran ◽  
H. F. Hinrichs ◽  
M. Kindler ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
Bone Metastases ◽  
Cancer Patients ◽  
Palliative Treatment ◽  
Open Label ◽  
Open Label Trial

scholarly journals Targeting Bone Metabolism in Patients with Advanced Prostate Cancer: Current Options and Controversies

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Tilman Todenhöfer ◽  
Arnulf Stenzl ◽  
Lorenz C. Hofbauer ◽  
Tilman D. Rachner
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Loss ◽  
Bone Metastases ◽  
Bone Disease ◽  
Mineral Density ◽  
Early Therapy ◽  
Ablation Therapy ◽  
Radium 223 ◽  
Antiresorptive Agents

Maintaining bone health remains a clinical challenge in patients with prostate cancer (PC) who are at risk of developing metastatic bone disease and increased bone loss due to hormone ablation therapy. In patients with cancer-treatment induced bone loss (CTIBL), antiresorptive agents have been shown to improve bone mineral density (BMD) and to reduce the risk of fractures. For patients with bone metastases, both zoledronic acid and denosumab delay skeletal related events (SREs) in the castration resistant stage of disease. Novel agents targeting the Wnt inhibitors dickkopf-1 and sclerostin are currently under investigation for the treatment of osteoporosis and malignant bone disease. New antineoplastic drugs such as abiraterone, enzalutamide, and Radium-223 are capable of further delaying SREs in patients with advanced PC. The benefit of antiresorptive treatment for patients with castration sensitive PC appears to be limited. Recent trials on the use of zoledronic acid for the prevention of bone metastases failed to be successful, whereas denosumab delayed the occurrence of bone metastases by a median of 4.1 months. Currently, the use of antiresorptive drugs to prevent bone metastases still remains a field of controversies and further trials are needed to identify patient subgroups that may profit from early therapy.

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.

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