Management of the australianclinicaltrials.gov.au website has been transferred from NHMRC to the Commonwealth Department of Health. Disruption to site users as a consequence of this change should be minimal.

Clinical Trial Details

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

Print record Print record
Trial Information

Broad Health Condition Cancer

Specific Health ConditionProstate

Trial Focus

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/07/2006

Anticipated date of last participant enrolment1/07/2006

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

The purpose of this study is to find out if a new genetic test (GSTP1 methylation) is a better way of assessing patients’ response to chemotherapy compared to the standard methods (eg PSA blood test). In addition, this study will attempt to find new ways of predicting patient’s response to chemotherapy before they start treatment.
Eligibility

Key inclusion criteria

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.

Minimum age18 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

 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).
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Dr Lisa Horvath
Primary Sponsor Address: Sydney Cancer Centre Royal Prince Alfred Hospital Missended Rd CAMPERDOWN NSW 2050
Primary Sponsor Country: Australia

Trial IDACTRN12607000077460

Contact person for information and recruitment
Mr Quoc Nguyen
PRIMe The Garvan Institute of Medical Research 384 Victoria St DARLINGHURST NSW 2010
+61 2 92958349
+61 2 9295 84223
Further information iconq.nguyen@garvan.org.au
Australia