ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

Other interventions

Comparator / control treatment

No comparator.

Control group

Uncontrolled

Outcomes

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 [1]

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 [2]

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 [3]

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 [1]

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 [2]

Measured every 3 weeks and/or follow up visit.

Secondary outcome [3]

3. To assess the effect of inflammation on response to chemotherapy.

Timepoint [3]

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?

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]

Other

Name [1]

GARVAN INSTITUTE

Address [1]

384 Victoria St
DARLINGHURST NSW 2010

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Cancer Australia

Address [2]

PO Box 1201
DICKSON ACT 2602

Country [2]

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]

Individual

Name [1]

Professor Robert Sutherland

Address [1]

The Garvan Institute of Medical Research
384 Victoria St
DARLINGHURST NSW 2010

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Prince Alfred Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/07/2005

Ethics approval number [1]

X05-0177

Ethics committee name [2]

Concord Repatriation General Hospital

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

29/06/2006

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Mr Quoc Nguyen

Address

PRIMe
The Garvan Institute of Medical Research
384 Victoria St
DARLINGHURST NSW 2010

Country

Australia

Phone

+61 2 92958349

Fax

+61 2 9295 84223

[email protected]

Contact person for scientific queries

Name

Dr. Lisa Horvath

Address

Royal Prince Alfred Hospital
Level 6
Gloucester House
Missenden Rd
Camperdown NSW 2050

Country

Australia

Phone

+61 2 95157680

Fax

+61 2 95155063

[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

Source	Title	Year of Publication	DOI
Embase	A distinct plasma lipid signature associated with poor prognosis in castration-resistant prostate cancer.	2017	https://dx.doi.org/10.1002/ijc.30903
Embase	Phase 2 study of circulating microRNA biomarkers in castration-resistant prostate cancer.	2017	https://dx.doi.org/10.1038/bjc.2017.50
Embase	Aberrations in circulating ceramide levels are associated with poor clinical outcomes across localised and metastatic prostate cancer.	2021	https://dx.doi.org/10.1038/s41391-021-00338-z
Dimensions AI	1408P Comparative transcriptomic analyses of 100,691 primary tumors from East Asian (EA) and North American (NA) men with prostate cancer (PCa)	2022	https://doi.org/10.1016/j.annonc.2022.07.1894
Dimensions AI	1409P Development of a clinically accessible, circulating prognostic lipid biomarker panel in men with mCRPC to guide potential metabolic intervention	2022	https://doi.org/10.1016/j.annonc.2022.07.1895
Dimensions AI	PCPro: a clinically accessible, circulating lipid biomarker signature for poor-prognosis metastatic prostate cancer	2023	https://doi.org/10.1038/s41391-023-00666-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically