Docetaxel and Prednisolone With or Without Zoledronic Acid and/or Strontium Chloride Sr 89 in Treating Patients With Prostate Cancer Metastatic to Bone That Has Not Responded to Hormone Therapy
- Conditions
- Prostate CancerMetastatic Cancer
- Registration Number
- NCT00554918
- Lead Sponsor
- University Hospital Birmingham
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Zoledronic acid may help relieve some of the symptoms caused by bone metastases. Radioactive substances, such as strontium chloride Sr 89, may help relieve bone pain caused by prostate cancer. Giving docetaxel together with prednisolone with or without zoledronic acid and/or strontium chloride Sr 89 may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving docetaxel together with prednisolone works with or without zoledronic acid and/or strontium chloride Sr 89 in treating patients with prostate cancer metastatic to bone that has not responded to hormone therapy.
- Detailed Description
OBJECTIVES:
Primary
* To assess the toxicity and tolerability of docetaxel with zoledronic acid.
* To assess the toxicity and tolerability of docetaxel with strontium chloride Sr 89.
* To assess the toxicity and tolerability of docetaxel with zoledronic acid and strontium chloride Sr 89.
Secondary
* Compare health economic endpoints between the treatment groups.
* Compare changes in bone mineral density between the treatment groups.
* Compare the biological profiling for prognostic and predictive indicators between the treatment groups.
Tertiary
* Compare median time to disease progression between the treatment groups.
* Compare pain progression-free survival (PFS) between the treatment groups.
* Compare PSA PFS between the treatment groups.
* Compare pain response between the treatment groups.
* Compare overall survival between the treatment groups.
* Compare quality of life between the treatment groups.
OUTLINE: This is a multicenter study. Patients are stratified according to treatment center and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 4 treatment arms.
* Arm I: Patients receive docetaxel IV on day 1 and oral prednisolone once daily.
* Arm II: Patients receive docetaxel and prednisolone as in arm I and zoledronic acid IV over 15 minutes on day 1.
* Arm III: Patients receive docetaxel and prednisolone as in arm I and a single dose of strontium chloride Sr 89 IV on day 7 of course 2.
* Arm IV: Patients receive docetaxel and prednisolone as in arm I, zoledronic acid as in arm II, and strontium chloride Sr 89 as in arm III.
Treatment with docetaxel, prednisolone, and zoledronic acid repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Strontium chloride Sr 89 is given as a one time single dose.
Quality of life is assessed using the Euroqual (EQ-5D) and FACT-P at baseline and every 3 months during follow up.
After completion of study, patients are followed every 3 months.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Toxicity and tolerability of docetaxel, zoledronic acid, and strontium chloride Sr 89 Toxicity and tolerability of docetaxel and zoledronic acid Toxicity and tolerability of docetaxel and strontium chloride Sr 89
- Secondary Outcome Measures
Name Time Method Quality of life Changes in bone mineral density Median time to disease progression Pain response Health Care economic analysis Pain progression-free survival (PFS) PSA PFS Overall survival
Trial Locations
- Locations (16)
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
🇬🇧Birmingham, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Walsall Manor Hospital
🇬🇧Walsall, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Crosshouse Hospital
🇬🇧Kilmarnock, Scotland, United Kingdom
Gloucestershire Royal Hospital
🇬🇧Gloucester, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Wishaw General Hospital
🇬🇧Wishaw, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Ayr Hospital
🇬🇧Ayr, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, Denbighshire, Wales, United Kingdom