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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
001533
ACTR Number:
ACTRN12607000077460
Trial Status:
Registered
Date Submitted:
22/01/2007
Date Registered:
23/01/2007
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Public title:
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
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ANZCTR registration title:
Prospective Study to investigate the ability of the GSTP1 methylation assay to assess response to chemotherapy in patients with metastatic hormone-refractory prostate cancer
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Secondary ID:
UTN:
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Trial acronym:
GSTP1
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Page 2
Health condition(s) or problem(s) studied:
Patients with Metastatic hormone-refractory prostate cancer
Condition category:
Condition code:
Cancer
Prostate
Page 3
Description of intervention(s) / exposure:
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.
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Comparator / control treatment:
No comparator.
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Control group:
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Page 4
Primary outcome 1:
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
Timepoint:
Assesment is done initially at baseline and 3 weeks interval or when patient is seen on follow up
Primary outcome 2:
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
Timepoint:
Assesment is done initially at baseline and 3 weeks interval or when patient is seen on follow up
Primary outcome 3:
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.
Timepoint:
Assesment is done initially at baseline and 3 weeks interval or when patient is seen on follow up
Secondary outcome 1:
1. To assess the ability of methylated GSTP1 levels to predict response to chemotherapy and overall prognosis.
Timepoint:
Measured every 3 weeks and/or follow up visit.
Secondary outcome 2:
2. To assess changes in Ribonucleic Acid (RNA) expression profiles between responders and non-responders to Taxotere.
Timepoint:
Measured every 3 weeks and/or follow up visit.
Secondary outcome 3:
3. To assess the effect of inflammation on response to chemotherapy.
Timepoint:
Measured every 3 weeks and/or follow up visit.
Page 5
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.
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Minimum Age:
18
Years
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Maximum Age:
Not stated
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Gender:
Males
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Healthy volunteers?
No
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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).
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Page 6
Study type:
Observational
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Purpose:
Screening
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Duration:
Cross-sectional
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Selection:
Defined population
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Timing:
Prospective
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Page 7
Phase
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Anticipated or actual date of first participant enrolement:
1/07/2006
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Target sample size:
150
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Recruitment status:
Open to recruitment
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Page 8
Funding source:
Other
Name:
GARVAN INSTITUTE
Address:
Country:
Australia
Primary sponsor:
Individual
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Name:
Dr Lisa Horvath
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Secondary sponsor:
Individual
Name:
Professor Robert Sutherland
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Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
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Reason:
Ethics Committee name 1:
Royal Prince Alfred Hospital
Address:
Country:
Australia
Date of approval:
28/07/2005
HREC Number:
X05-0177
Ethics Committee name 2:
Concord Repatriation General Hospital
Address:
Country:
Australia
Date of approval:
29/06/2006
HREC Number:
CH62/6/2005-133
Countries of recruitment:
Australia
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.
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Page 10
Contact person for public queries
Name:
Albert Woo
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Address:
Royal Prince Alfred Hospital Level 6 Gloucester House Missenden Rd Camperdown NSW 2050
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Country:
Australia
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Tel:
+61 2 95156902
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Fax:
+61 2 95155063
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Email:
albert.woo@email.cs.nsw.gov.au
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Contact person for scientific queries
Name:
Dr. Lisa Horvath
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Address:
Royal Prince Alfred Hospital Level 6 Gloucester House Missenden Rd Camperdown NSW 2050
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Country:
Australia
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Tel:
+61 2 95157680
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Fax:
+61 2 95155063
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Email:
lisa.horvath@cs.nsw.gov.au
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