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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000540910

Acronym

MIC-1 Study

Enrollment

150

Registered

2011-05-25

Start date

2010-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results