The use of Peroxisome Proliferator Activator Receptor Agonists in the management of Androgen Independent Prostate Cancer - PPAR

Phase 1

• Conditions: 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

• Registration Number: EUCTR2006-001398-44-GB
• Lead Sponsor: Barts and The London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-31
• Study Completion: 2015-11-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 49

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

1.Receiving thiazolidenedione therapy or other oral hypoglycaemics
2.Receiving fibrate therapy for hyperlipidemia
3.Symptomatic disease requiring urgent palliation
4.Life expectancy < 4 months
5.Severe renal or hepatic dysfunction (Creatinine >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified