The use of Peroxisome Proliferator Activator Receptor Agonists in the management of Androgen Independent Prostate Cancer. Open-labeled, non-randomised clinical trial in patients with androgen independent prostate cancer
Conditions
Interventions
Trade Name: LIPANTIL
Product Name: Lipantil Micro
Pharmaceutical Form: Capsule
INN or Proposed INN: Lipantil Micro 267
Concentration uni
Sponsors
Barts and The London NHS Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Androgen independent prostate cancer defined as rising PSA in the presence of MAB (withdrawal of peripheral anti-androgen 6 weeks prior to enrolment if previous response to addition of peripheral anti-androgen) 2. ECOG performance status 0-2 (see appendix 1 for ECOG grading) 3. Asymptomatic (lower urinary tract symptoms alone excluding haematuria is acceptable) 4. Rising PSA 5. Willing to undertake 6 weeks monitoring prior to starting treatment 6. Males = 16 years of age 7. Patients who have given written informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Receiving thiazolidenedione therapy or other oral hypoglycaemics 2. Receiving fibrate therapy for hyperlipidemia 3. Symptomatic disease requiring urgent palliation 4. Life expectancy 200 µmol/l, Bilirubin >3xULN, ALT or AST >4xULN) 6. Cardiac failure (new or treated) 7. Concurrent participation in an interventional (drug) clinical trial 8. Currently receiving treatment for Diabetes Mellitus (except diet controlled) 9. Patient taking Diclofenac (may substitute an alternative non-steroidal anti-inflammatory drug prior to study entry) 10. Unwilling or unable to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is PSA doubling time;Secondary Objective: The secondary objectives are to find PSA response, evaluate treatment toxicity, quality of life (using the EORTC QLQ-C30 and EORTC QLQ-PR25 quality of life assessments) and time to progression. ;Primary end point(s): PSA doubling time | — |
Countries
United Kingdom
Outcome results
None listed