ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases

Prostate Cancer Clinical Trial

Official title:

Randomised Open-label Multicenter Prosp. Clinical Study to Show the Efficacy of IV ZOMETA® 4mg for Prevention of Bone Metastases in Hormone-naïve High Risk Patients With Locally Advanced Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00294437
• Other study ID #: CECOG/prostate 1.2.001
• Status: Terminated
• Phase: Phase 3
• First received: February 20, 2006
• Last updated: April 30, 2012
• Start date: December 2003
• Est. completion date: November 2007

Study information

• Verified date: April 2012
• Source: Central European Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

To determine if therapy with Zometa® (zoledronic acid) 4mg will be effective in preventing the occurrence of bone metastases in prostate cancer patients at high risk of developing them. In addition, pain and analgesic scores and overall safety are to be evaluated throughout the study.

Description:

This is a prospective, randomized, stratified open-label (Zometa + hormonal ablation versus hormonal ablation alone) multicenter clinical study evaluating the efficacy of Zometa 4mg given every 3 month as an adjunct to hormonal or surgical castration for prevention of bone metastases in locally advanced, high risk prostate cancer patients, who are hormone-naiv at time of randomization. the primary efficacy variable is the time to occurrence of first bone metastases.

Zometa® (zoledronic acid) provided as 4mg lyophilised powder Supplementation 500mg Calcium +400-500IU Vitamin D p.o. qd

Arm A:

Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months

Arm B:

no reference therapy

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 376
• Est. completion date: November 2007
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent

• Age > 18 years

• Histologically confirmed diagnosis of carcinoma of the prostate

• ECOG performance status of 0, 1, or 2

• No radiological evident bone metastasis (negative bone scan or verification of suspected foci as benign lesions by additional radiological examination)

• T3-4 AND highest pre-study PSA >20 ng/ml AND Gleason score = 8 (or Gleason grade = 4)

• Patients with prior prostatectomy or prior local radiotherapy are eligible for this study

• Patients are destined to receive medical (LHRH analogue) or surgical (orchiectomy) castration and Zometa® treatment will start not later than 6 weeks after surgery

• Patients should be fully recovered from prior interventions where applicable

Exclusion Criteria:

• Patients with a serum creatinine determination >265 µmol/L (3.0 mg/dL)

• Patients that received prior medical (LHRH analogue) castration

• Current (or previous) evidence of metastatic disease to the bone

• History of any other neoplasm within the past five years except for nonmelanomatous skin cancer.

• Previous hormonal therapy with LHRH agonists or other forms of hormonal ablation

• WBC<3.0x109, ANC < 1500/mm3, Hgb<8.0 g/dL, platelets < 75 x 109/L

• Liver function tests >2.5 ULN

• Prior treatment with Zometa® (zoledronic acid) or other bisphosphonates

• Treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to the date of randomization (Visit 2)

• Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of randomization (Visit 2)

• Patients with evidence in the six months prior to randomization of severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or symptomatic coronary artery disease uncontrolled by treatment

• History of noncompliance to medical regimens and patients who are considered potentially unreliable or incapable of giving informed consent as judged by the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zometa
Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months

Locations

Country	Name	City	State
Austria	Thermenkh Baden, Urologie	Baden bei Wien
Austria	LKH Graz Univ. Klinik f Urologie	Graz
Austria	LKH Innsbruck, Dept f. Urologie	Innsbruck
Austria	LKH Leoben, Abt. für Innere Medizin	Leoben	Steiermark
Austria	KH d Elisabethinen Linz, Dep of Urology	Linz
Austria	KH der Barmherzigen Schwestern, Dept Urologie	Linz
Austria	LKH Salzburg, Clinic f Radiotherapy a Radiooncology	Salzburg
Bosnia and Herzegovina	Institute for Oncology	Sarajevo
Bulgaria	Plovdiv Cancer Center	Plovdiv
Bulgaria	SBALO National Oncology Center	Sofia
Bulgaria	SBALO National Oncology Center	Sofia
Bulgaria	Sofia Cancer Center compl. Mladost ,	Sofia
Bulgaria	MODOSZ Oncology Dispensary	Stara Zagora
Bulgaria	Modozs-Veliko	Tarnovo
Bulgaria	Oncological Hospital	Varna
Croatia	Univ. Hospital, Dep of Pathophysiology	Split
Croatia	GH, Dep Oncology and Reumatology	Varazdin
Croatia	Clinical Hospital	Zagreb
Czech Republic	FH, Urological Clinic	Brno
Czech Republic	Hospital Kromeriz, Dep of Urology	Kromeriz
Czech Republic	FN Motol, Dep of Urology	Prague
Czech Republic	Centre of Oncology	Usti Nad Labem
Estonia	Mustamae Korpus	Tallinn
Estonia	Clinic of surgery	Tartu
Hungary	Dept. Of Urology , Jahn Ferenc Delpesti Hospital	Budapest
Hungary	karolyi sandor Hospital, Dept of Urology	Budapest
Hungary	Semmelweiss Univ of Medicine, Clinic of Urology	Budapest
Hungary	Univ. of Pecs,Urologic Clinic	Pecs
Hungary	Dept. Of Urology and Surgery	Szombathely
Lithuania	Lithuanian Oncology Center	Vilnius
Montenegro	Clinical Center of Montenegro	Podgorica
Poland	Centrum Onkologii Instytut	Krakow
Poland	Medical Academy	Szczecin
Poland	Central Rail Hospital,	Warsaw
Poland	Medical Academy	Warsaw
Romania	P.D.R. Clinic	Brasov
Romania	Fundeni Hospital, Dep of Urology	Bucharest
Romania	Saint John Emergency Clinical Hospital	Bucharest
Romania	Institutul Oncologic Cluj	Cluj-Napoca
Romania	Emergency Clinical County Hospital , Clin Oncol. Dep	Craiova
Romania	University Hospital	Iasi
Russian Federation	Hertzen Research Oncological Institute	Moscow
Russian Federation	Medical Radiological Research Center	Obninsk
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Oncology Institute	Belgrade
Serbia	Oncology Institute Belgrade	Belgrade
Serbia	Clinical Center	Nis
Serbia	Institute for Oncology	Sremska Kamenica
Slovakia	FNsP - akad L. Derea Urology	Bratislava
Slovakia	FNsP Dep of Urology	Kosice
Slovakia	FN sP Dep of Urology	Martin
Slovenia	University Clinical Center	Ljubljana
Slovenia	Gh, Dep of Urology	Maribor
South Africa	Turret House	Claremont
South Africa	Johannesburg Hospital Dep of Urology	Johannesburg
South Africa	St. Annes Hospital	Pietermaritzburg
South Africa	Urological Hospital	Pretoria

Sponsors (1)

Lead Sponsor	Collaborator
Central European Cooperative Oncology Group

Countries where clinical trial is conducted

Austria,  Bosnia and Herzegovina,  Bulgaria,  Croatia,  Czech Republic,  Estonia,  Hungary,  Lithuania,  Montenegro,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to occurrence of first bone metastasis, as assessed by bone scan and confirmed by additional radiological examination
Secondary	To assess the effects of i.v. Zometa® (zoledronic acid) 4 mg, with respect to the following efficacy parameters as well as safety and tolerability:
Secondary	Effects on pain and analgesic drug consumption, assessed by the composite pain score from BPI (Brief Pain Inventory) for pain and by analgesic score
Secondary	Time to first event of bone pain
Secondary	Time to first occurrence of Skeletal Related Events (SREs), defined as pathologic bone fractures, spinal cord compression, surgery to bone, radiation therapy to bone (including the use of radioisotopes)
Secondary	Proportion of patients in each arm having SRE
Secondary	Serum PSA
Secondary	Overall safety

External Links

•   Link