RecruitingACTRN12607000077460

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

Prospective Study to investigate the ability of the GSTP1 methylation assay to assess response to chemotherapy in patients with metastatic hormone-refractory prostate cancer


Sponsor

Dr Lisa Horvath

Enrollment

150 participants

Start Date

Jul 1, 2006

Study Type

Observational

Conditions

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

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for men with advanced prostate cancer that has stopped responding to hormone therapy (called hormone-refractory prostate cancer). It tests whether a new genetic blood test (called GSTP1 methylation assay) can more accurately track whether chemotherapy is working, compared to the standard PSA blood test. The study also aims to find ways to predict before treatment starts whether a patient will respond to chemotherapy. You may be eligible if: - You are male and 18 years of age or older - You have prostate cancer confirmed by a tissue or cell sample - Your cancer has spread to other parts of the body - Your cancer no longer responds to hormone therapy (hormone-refractory) - Your PSA level is above 10 ng/ml and has risen on at least two consecutive tests - Your general health level (ECOG performance status) is 0 to 3 - Your blood counts and liver and kidney function are within acceptable ranges - Your testosterone is at castrate levels You may NOT be eligible if: - You are taking alternative supplements such as Saw Palmetto, DHEA, lycopene, vitamin D, or selenium - You are receiving chemotherapy other than Docetaxel or Mitoxantrone Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

To Assess whether quantitative assessment of the methylated GSTP1 as a marker of Tumour Burden could be better assay for assessing response to treatment over the 18 week treatment period and 6 weekly

To Assess whether quantitative assessment of the methylated GSTP1 as a marker of Tumour Burden could be better assay for assessing response to treatment over the 18 week treatment period and 6 weekly follow up post treatment.


Locations(1)

Australia

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ACTRN12607000077460