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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022010-32-GB

Enrollment

Registered

2011-05-09

Start date

2011-08-15

Completion date

Unknown

Last updated

2020-07-27

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

Conditions

Castration Resistent Prostate cancer

Interventions

Trade Name: Kenalog Product Name: Triamcinolone Product Code: n/a Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the prostate 2. Progressive disease despite castration with an elevated PSA >5ng/ml (testosterone =65 years) yes F.1.3.1 Number of subjects for this age range 41

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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 2. Time to symptomatic progression 3. CTC response at 28 days 4. To evaluate translational endpoints ;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 progression or death.	—

Measure

Time frame

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 2. Time to symptomatic progression 3. CTC response at 28 days 4. To evaluate translational endpoints ;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 progression or death.

—

Secondary

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

Countries

United Kingdom

Contacts

Public ContactJonathan SHamash

Barts and The London NHS Trust

jonathan.shamash@bartsandthelondon.nhs.uk02034657108

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026