Prospective Study to investigate the ability of the Glutathione S- transferase Pi (GSTP1) methylation assay to assess response to chemotherapy in patients with metastatic hormone-refractory prostate cancer
- Conditions
- Patients with Metastatic hormone-refractory prostate cancerCancer - Prostate
- Registration Number
- ACTRN12607000077460
- Lead Sponsor
- Dr Lisa Horvath
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 150
1. Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.2. Confirmed Hormone-refractory prostate cancer (HRPC) with a minimum of 4 weeks having elapsed between the withdrawal of antiandrogens and enrolment.3. Patients must have a baseline serum Prostate-specific antigen (PSA)> 10 ng/ml (referred to as PSA #1), and two consecutive rises in serum PSA (referred to as PSA #2 and PSA #3) greater than PSA #1 with each test performed at least one week apart. If PSA #3 is less than PSA #2, the patient remains eligible provided a fourth PSA (PSA #4) is greater than PSA #2.4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-3.5. A neutrophil count of at least 1500 per cubic millimetre and a platelet count of at least 100 000 per cubic millimetre.6. Normal bilirubin level and AST, ALT and serum creatinine no more than 1.5 times the upper limit of the normal range. 7. Castrate testosterone levels due to either luteinizing hormone-releasing hormone (LHRH) agonists or orchidectomy.8. Informed consent.
1. Patients taking alternative therapies (eg Saw Palmetto, dehydroepiandrosterone (DHEA), lycopene, PC-SPES, vitamin D, selenium).2. Patients receiving chemotherapy other than Docetaxel or Mitoxantrone (eg cyclophosphamide).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the utility of the assay for GSTP1 methylation as a marker of tumour response compared to the conventional clinical endpoints of (1) fall in serum PSA[Assesment is done initially at baseline and 3 weeks interval or when patient is seen on follow up];The primary objective of this study is to assess the utility of the assay for GSTP1 methylation as a marker of tumour response compared to the conventional clinical endpoints of (2) objective measurable response[Assesment is done initially at baseline and 3 weeks interval or when patient is seen on follow up];The primary objective of this study is to assess the utility of the assay for GSTP1 methylation as a marker of tumour response compared to the conventional clinical endpoints of (3) decrease in pain as measured by a pain intensity scale. [Assesment is done initially at baseline and 3 weeks interval or when patient is seen on follow up]
- Secondary Outcome Measures
Name Time Method 1. To assess the ability of methylated GSTP1 levels to predict response to chemotherapy and overall prognosis.[Measured every 3 weeks and/or follow up visit.];2. To assess changes in Ribonucleic Acid (RNA) expression profiles between responders and non-responders to Taxotere. [Measured every 3 weeks and/or follow up visit.];3. To assess the effect of inflammation on response to chemotherapy.[Measured every 3 weeks and/or follow up visit.]