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Trial registered on ANZCTR


Registration number
ACTRN12611000540910
Ethics application status
Approved
Date submitted
22/04/2010
Date registered
25/05/2011
Date last updated
16/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 253094 0
Nil
Universal Trial Number (UTN)
Trial acronym
MIC-1 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic castrate-resistant prostate cancer 257033 0
Condition category
Condition code
Cancer 257190 257190 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All patients will receive standard of care chemotherapy but will have sequential blood samples taken for analysis of plasma MIC-1 levels and the levels of associated biomarkers. Patients will be observed until death. The trial accrual will be 3 years but the overall duration of the study will be 5 years.
Intervention code [1] 256205 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258082 0
To assess the ability of plasma MIC-1 and associated plasma biomarkers to predict the tumour response to chemotherapy compared to the conventional clinical endpoints of serum Prostate Specific Antigen (PSA), objective measurable response (as measured by CT scan and bone scan) and decrease in pain (as measured by 5-point pain scale).
Timepoint [1] 258082 0
6 months from baseline enrollment.
Primary outcome [2] 266830 0
To determine the relationship between the plasma levels of MIC-1 and PSA response
Timepoint [2] 266830 0
Patients will be followed from enrollment until death which will generally be 12-24 months from baseline.
Secondary outcome [1] 263678 0
To assess the ability of plasma MIC-1 and associated plasma biomarkers to predict overall survival.
Timepoint [1] 263678 0
Patients will be followed from enrollment until death which will generally be 12-24 months from baseline.

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 age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. No histological diagnosis of prostate cancer

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 256707 0
Government body
Name [1] 256707 0
Cancer Australia
Address [1] 256707 0
PO Box 1201
Dickson ACT 2602
Country [1] 256707 0
Australia
Primary sponsor type
Government body
Name
Cancer Australia
Address
PO Box 1201
Dickson ACT 2602
Country
Australia
Secondary sponsor category [1] 255994 0
None
Name [1] 255994 0
Address [1] 255994 0
Country [1] 255994 0
Other collaborator category [1] 1167 0
Other Collaborative groups
Name [1] 1167 0
Garvan Institute for Medical Research
Address [1] 1167 0
384 Victoria Street
Darlinghurst
Sydney 2010 NSW
Country [1] 1167 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258719 0
Royal Prince Alfred Hospital
Ethics committee address [1] 258719 0
Missenden Rd
Camperdown
Sydney 2050 NSW
Ethics committee country [1] 258719 0
Australia
Date submitted for ethics approval [1] 258719 0
Approval date [1] 258719 0
09/07/2010
Ethics approval number [1] 258719 0
HREC/10/RPAH/289
Ethics committee name [2] 269125 0
Royal Prince Alfred Ethics Committee
Ethics committee address [2] 269125 0
Royal Prince Alfred Hospital
Missenden Rd
CAMPERDOWN NSW 2050
Ethics committee country [2] 269125 0
Australia
Date submitted for ethics approval [2] 269125 0
Approval date [2] 269125 0
09/07/2010
Ethics approval number [2] 269125 0
HREC/10/RPAH/289

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30980 0
Address 30980 0
Country 30980 0
Phone 30980 0
Fax 30980 0
Email 30980 0
Contact person for public queries
Name 14227 0
A./Prof. Lisa Horvath
Address 14227 0
Sydney Cancer Centre
Missenden Rd
Camperdown
NSW 2050
Country 14227 0
Australia
Phone 14227 0
612 9515 5494
Fax 14227 0
612 9519 1546
Email 14227 0
lisa.horvath@sswahs.nsw.gov.au
Contact person for scientific queries
Name 5155 0
A./Prof. Lisa Horvath
Address 5155 0
Sydney Cancer Centre
Missenden Rd
Camperdown
NSW 2050
Country 5155 0
Australia
Phone 5155 0
612 9515 5494
Fax 5155 0
612 9519 1546
Email 5155 0
lisa.horvath@sswahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results