A phase II, randomised, double-blind, parallel-group, placebo-controlled, multi-centre study to assess the efficacy and safety of once-daily orally administered ZD4054 15 mg and 10 mg doses in pain-free or mildly symptomatic patients with prostate cancer and bone metastases, who have rising serum prostate specific antigen (PSA) levels despite medical or surgical castration - EPOC

AstraZeneca AB0 sites260 target enrollmentMay 28, 2004

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: AstraZeneca AB
Enrollment: 260
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 28, 2004

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

AstraZeneca AB

Eligibility Criteria

Inclusion Criteria

•1\.Provision of written informed consent to participate in the study
•2\.Male, aged 18 years or older
•3\.Surgically castrated or continuously medically castrated.
•4\.Patients with a serum testosterone inferior or equal to 2\.4 nmol/L (70 ng/dL)
•5\.Histological or cytological confirmation of adenocarcinoma of the prostate.
•6\.Documented evidence of bone metastases, as assessed by bone scintigraphy performed according to the standard bone acquisition protocol developed specifically for this study.
•\-Patients must have disease involvement of less than 75% of the spine, 75% of the pelvis or 75% of the ribs in the anteroposterior (AP) or posteroanterior (PA) view.
•7\.Biochemical progression of prostate cancer, documented while the patient is castrate, by a rise in PSA that meets any one or more of the following criteria:
•Biochemical progression criterion 1:
•A second PSA value higher than a first PSA (reference) value. To be followed by a third PSA value higher than the second value.

Exclusion Criteria

•1\.Current use (from the time that written informed consent is given) of any opiates listed in Appendix E of the protocol.
•2\.Prior radiotherapy to bone metastases within 4 weeks of randomisation to the study.
•3\.Prior cytotoxic chemotherapy for the treatment of their recurrent prostate cancer, such as estramustine, paclitaxel, docetaxel and mitoxantrone.
•4\.Corticosteroids, including hydrocortisone, for the treatment of their recurrent prostate cancer within 4 weeks of randomisation to the study. Please note that if taking corticosteroids for another reason, the treatment must be at a dose that is stable for a minimum of 12 weeks prior to randomisation to the study.
•5\.Antiandrogens, within 4 weeks of randomisation to the study for flutamide or within 6 weeks of randomisation to the study for bicalutamide and nilutamide. Continued elevation of their PSA, according to inclusion criterion number 7 (see Section 3\.3\.2 in the protocol), can be demonstrated during the washout times provided above.
•6\.Treatment with strontium\-89, rhenium\-186\-HEDP and samarium\-153\-EDTMP for bone metastases, within 12 weeks of randomisation to the study.
•7\.Neurologic symptoms or signs consistent with acute or evolving spinal cord compression, confirmed with MRI. Stable, previously treated patients are allowed.
•8\.Stage II, III or IV cardiac failure, classified according to New York Heart Association (NYHA) classification.
•9\.QT interval corrected for heart rate (QTc) \>470 msec.
•10\.In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, (eg, currently unstable or uncompensated respiratory, cardiac, hepatic or renal disease) or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.