A phase II single arm, multi-centre trial of triamcinolone with a GnRH analog for castration resistant prostate cancer

Phase 1

• Conditions: Castration Resistent Prostate cancer; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2010-022010-32-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: 2011-05-09
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 41

Inclusion Criteria

1.Histologically confirmed adenocarcinoma of the prostate
2.Progressive disease despite castration with an elevated PSA >5ng/ml (testosterone <1.5nmol/l or failure of GnRH analogue with peripheral anti-androgen if non-castrate level on GnRH alone)
3.ECOG performance status (PS) 0-3 and considered by responsible consultant suitable to undergo treatment
4.Males aged greater or equal 18
5.Patients who are able to understand their participation in the study and give written informed consent

Are the trial subjects under 18? no
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 41
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 41

Exclusion Criteria

1.Contraindication to intramuscular injections
2.Unable to titrate medication for type 2 diabetes if deterioration in control on triamcinolone
3.Absolute contraindication to corticosteroids
4.Previous use of corticosteroids in prostate cancer
5.Previous chemotherapy for prostate cancer
6.Current participation in any other investigational drug study
7.History of a malignancy within 5 years except those treated with curative intent for skin cancer (other than melanoma)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether patients with castration resistant prostate cancer survive without their cancer getting worse (progression free survival) for longer than standard treatment, when receiving triamcinolone whilst continuing GnRH analog treatment and following failure of hormone therapy. This will be assessed by measuring PSA levels. ;Secondary Objective: 1.Time to PSA progression<br>2.Time to symptomatic progression<br>3.CTC response at 28 days<br>4.To evaluate translational endpoints<br>;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: Time from first administration of study drug to the first observation of disease<br>progression or death.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Time to PSA progression, symptomatic progression, CTC response at 28 days<br><br>Translational endpoints: Effect of T887A and AR ccr on response to treatment.<br>Blood sample collection: SNP analysis for those involved in<br>androgen synthesis and metabolism;Timepoint(s) of evaluation of this end point: Circulating tumour cell response evaluation at 28days