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Key exclusion criteria:
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Exclusion criteria:Evidence of metastatic diseasePrior cytotoxic chemotherapy.Prior hormone therapy.Treatment with an investigational agent in the last 4 weeks.Other co-existing malignancies or malignancies diagnosed within the last 2 years with the exception of non-melanoma skin cancer.Incomplete healing from previous surgery.Absolute neutrophil count (ANC) < 1 x 109/L or platelets < 100 x 109/L.Serum bilirubin > 1.25 times the upper limit of reference range (ULRR).Initial serum creatinine 1.5 times the ULN and/or calculated creatinine clearance (by Cockroft-Gault Formula) <60 ml/min and/or known progressive renal disease. ALT or AST > 2.5 times the ULRR.Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.Recent (within 6 weeks) or planned dental or jaw surgery (e.g.extraction, implants)In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial. |
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Brief summary: |
Certain patients are at high risk of developing secondary, or metastatic, prostate cancer, after radical prostatectomy. These are patients whose prostate biopsy shows that they have a high Gleason grade, or aggressive prostate cancer, patients whose PSA level is high (>10ng/mL) or whose prostate feels abnormal on digital rectal examination.
The standard treatment approach for men with this high risk of secondary prostate cancer is close observation by their treating doctor and appropriate treatment if prostate cancer returns. This study aims to compare this standard approach with giving patients the combination of a drug called zoledronic acid (also known as Zometa®) a drug called docetaxel (also known as Taxotere®) and luteinising hormone-releasing hormone (LH-RH) analogue also known as hormone therapy.
Zoledronic acid, docetaxel and hormone therapy are routinely used in men with prostate cancer that has spread to the bone or other parts of the body (metastatic disease). Zoledronic acid is used in this situation to prevent bone complications from the cancer including fractures. Docetaxel is a chemotherapy drug that is used in this situation to control symptoms and prolong survival. Both drugs are routinely used in a variety of other cancers for the same reasons. Hormone therapy used to reduce testosterone production. Testosterone stimulates the growth of prostate cancer.
An additional, non-compulsory part of the study will be to look at the usefulness of examining patient’s prostate tumors to determine reasons why some tumors respond to therapy and others do not.. You will be given a second Plain Language Statement regarding this additional study. |
