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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12607000077460

Acronym

GSTP1

Enrollment

150

Registered

2007-01-23

Start date

2006-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 follow up post treatment.

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

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.

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).

Outcome results