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Clinical Trial Details

Phase II study investigating the ability of Macrophage Inhibitory Cytokine-1 (MIC-1) and associated plasma markers to predict response to chemotherapy in men with metastatic castrate-resistant prostate cancer

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionProstate

Trial Focus

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/01/2010

Anticipated date of last participant enrolment1/01/2010

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

Advanced prostate cancer is the second leading cause of cancer death in Australian men. Chemotherapy (Docetaxel) is effective in only 50% of patients with this disease. A molecule, MIC-1, is a potential predictive blood marker and mediator of Docetaxel resistance. This clinical trial will test whether the MIC-1 blood test is a predictor of Docetaxel resistance.
Eligibility

Key inclusion criteria

1.	Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.
2.	Confirmed castrate-resistant prostate cancer (CRPC) with a minimum of 4 weeks having elapsed between the withdrawal of antiandrogens and enrolment.
3.	Patients must have a baseline serum 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.	Age > 18 years.
5.	Eastern Cooperative Oncology Group Performance status 0-3.
6.	A neutrophil count of at least 1500 per cubic millimetre and a platelet count of at least 100 000 per cubic millimetre.
7.	Normal bilirubin level and aspartate aminotransferase, alanine aminotransferase and serum creatinine no more than 1.5 times the upper limit of the normal range.
8.	Castrate testosterone levels due to either gonadotrophin-releasing hormone (GNRH) agonists or orchidectomy.
9.	Informed consent.

Minimum age18 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

1. No histological diagnosis of prostate cancer
Contact details and further information

Sponsor Primary Sponsor Type: Government body
Primary Sponsor Name: Cancer Australia
Primary Sponsor Address: PO Box 1201 Dickson ACT 2602
Primary Sponsor Country: Australia

Trial IDACTRN12611000540910

Contact person for information and recruitment
A./Prof. Lisa Horvath
Sydney Cancer Centre Missenden Rd Camperdown NSW 2050
612 9515 5494
612 9519 1546
Further information iconlisa.horvath@sswahs.nsw.gov.au
Australia