None listed
Conditions
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.
Interventions
Docetaxel 75mgm/m2 intravenously every 3 weeks for 4 cycles.
Zoledronic acid 4mgm intravenously every 3 weeks for 4 cycles.
Goserelin acetate 10.5 mgm subcutaneously x 1 dose.
All administered prior to radical prostatectomy.
Sponsors
Urology Department The Royal Melbourne Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria:Provision of written informed consent, Prostate cancer confirmed by biopsy within 6 weeks prior to consent. At least one of the following: PSA level > 15 g/L, Gleason score > 8, Clinical stage T2b or T3 disease at study entry. >50% of positive coresConsidered suitable for radical prostatectomy
Exclusion criteria
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.
Outcome results
None listed