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

Not Applicable

Recruiting

• Conditions: Metastatic castrate-resistant prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12611000540910
• Lead Sponsor: Cancer Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 150

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.

Exclusion Criteria

1. No histological diagnosis of prostate cancer

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the relationship between the plasma levels of MIC-1 and PSA response[Patients will be followed from enrollment until death which will generally be 12-24 months from baseline.];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).[6 months from baseline enrollment.]

Secondary Outcome Measures

Name	Time	Method
To assess the ability of plasma MIC-1 and associated plasma biomarkers to predict overall survival.[Patients will be followed from enrollment until death which will generally be 12-24 months from baseline.]