Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000077460
Ethics application status
Approved
Date submitted
22/01/2007
Date registered
23/01/2007
Date last updated
16/11/2015
Type of registration
Retrospectively registered

Titles & IDs
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
Scientific 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
Secondary ID [1] 259836 0
GSTP1 study
Universal Trial Number (UTN)
Trial acronym
GSTP1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with Metastatic hormone-refractory prostate cancer 1569 0
Condition category
Condition code
Cancer 1670 1670 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 1270 0
Other interventions
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2310 0
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 [1] 2310 0
Assesment is done initially at baseline and 3 weeks interval or when patient is seen on follow up
Primary outcome [2] 2311 0
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 [2] 2311 0
Assesment is done initially at baseline and 3 weeks interval or when patient is seen on follow up
Primary outcome [3] 2312 0
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 [3] 2312 0
Assesment is done initially at baseline and 3 weeks interval or when patient is seen on follow up
Secondary outcome [1] 4036 0
1. To assess the ability of methylated GSTP1 levels to predict response to chemotherapy and overall prognosis.
Timepoint [1] 4036 0
Measured every 3 weeks and/or follow up visit.
Secondary outcome [2] 4037 0
2. To assess changes in Ribonucleic Acid (RNA) expression profiles between responders and non-responders to Taxotere.
Timepoint [2] 4037 0
Measured every 3 weeks and/or follow up visit.
Secondary outcome [3] 4038 0
3. To assess the effect of inflammation on response to chemotherapy.
Timepoint [3] 4038 0
Measured every 3 weeks and/or follow up visit.

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 age
18 Years
Maximum age
Not stated
Sex
Males
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).

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1815 0
Other
Name [1] 1815 0
GARVAN INSTITUTE
Country [1] 1815 0
Australia
Funding source category [2] 264714 0
Government body
Name [2] 264714 0
Cancer Australia
Country [2] 264714 0
Australia
Primary sponsor type
Individual
Name
Dr Lisa Horvath
Address
Sydney Cancer Centre
Royal Prince Alfred Hospital
Missended Rd
CAMPERDOWN NSW 2050
Country
Australia
Secondary sponsor category [1] 1637 0
Individual
Name [1] 1637 0
Professor Robert Sutherland
Address [1] 1637 0
The Garvan Institute of Medical Research
384 Victoria St
DARLINGHURST NSW 2010
Country [1] 1637 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3403 0
Royal Prince Alfred Hospital
Ethics committee address [1] 3403 0
Ethics committee country [1] 3403 0
Australia
Date submitted for ethics approval [1] 3403 0
Approval date [1] 3403 0
28/07/2005
Ethics approval number [1] 3403 0
X05-0177
Ethics committee name [2] 3404 0
Concord Repatriation General Hospital
Ethics committee address [2] 3404 0
Ethics committee country [2] 3404 0
Australia
Date submitted for ethics approval [2] 3404 0
Approval date [2] 3404 0
29/06/2006
Ethics approval number [2] 3404 0
CH62/6/2005-133

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35192 0
Address 35192 0
Country 35192 0
Phone 35192 0
Fax 35192 0
Email 35192 0
Contact person for public queries
Name 10459 0
Mr Quoc Nguyen
Address 10459 0
PRIMe
The Garvan Institute of Medical Research
384 Victoria St
DARLINGHURST NSW 2010
Country 10459 0
Australia
Phone 10459 0
+61 2 92958349
Fax 10459 0
+61 2 9295 84223
Email 10459 0
[email protected]
Contact person for scientific queries
Name 1387 0
Dr. Lisa Horvath
Address 1387 0
Royal Prince Alfred Hospital
Level 6
Gloucester House
Missenden Rd
Camperdown NSW 2050
Country 1387 0
Australia
Phone 1387 0
+61 2 95157680
Fax 1387 0
+61 2 95155063
Email 1387 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePhase 2 study of circulating microRNA biomarkers in castration-resistant prostate cancer.2017https://dx.doi.org/10.1038/bjc.2017.50
EmbaseA distinct plasma lipid signature associated with poor prognosis in castration-resistant prostate cancer.2017https://dx.doi.org/10.1002/ijc.30903
EmbaseAberrations in circulating ceramide levels are associated with poor clinical outcomes across localised and metastatic prostate cancer.2021https://dx.doi.org/10.1038/s41391-021-00338-z
Dimensions AIPCPro: a clinically accessible, circulating lipid biomarker signature for poor-prognosis metastatic prostate cancer2023https://doi.org/10.1038/s41391-023-00666-2
Dimensions AI1408P Comparative transcriptomic analyses of 100,691 primary tumors from East Asian (EA) and North American (NA) men with prostate cancer (PCa)2022https://doi.org/10.1016/j.annonc.2022.07.1894
Dimensions AI1409P Development of a clinically accessible, circulating prognostic lipid biomarker panel in men with mCRPC to guide potential metabolic intervention2022https://doi.org/10.1016/j.annonc.2022.07.1895
N.B. These documents automatically identified may not have been verified by the study sponsor.