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A Trial of Triamcinolone With a GnRH Analog for Castration Resistant Prostate Cancer

NCT07161778 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-09-09

No results posted yet for this study

Summary

When metastatic prostate cancer becomes unresponsive to hormone therapy, it is known as castration resistant prostate cancer, treatment options are limited and response to this treatment can be short.

The standard treatment for this type of cancer (hydrocortisone or dexamethasone) gives an average response time of 4 months. After this chemotherapy would be considered. In this patient population the majority of men are aged over 70, so giving chemotherapy with its associated toxicities; can reduce the quality of life for patients, and it is preferable to delay this treatment option until absolutely necessary. With this in mind, treating with triamcinolone aims to increase this period of response.

One of the ways that castration resistant prostate cancer develops is by acquiring a mutations that allow it to respond to other steroids both endogenous e.g. cortisol and also to synthetic steroids being used to control the disease e.g. dexamethasone. No known mutation allows a response to triamcinolone, a unique finding amongst steroids.

To date there has been one clinical study looking at giving oral triamcinolone, but as yet there has been not study of intramuscular triamcinolone

Conditions

  • Castration Resistant Prostate Cancer

Interventions

DRUG

Triamcinolone acetonide IM injection

An initial loading dosage will be given and then every 4 weeks the patient will be given triamcinolone. Triamcinolone acetonide IM injection should be administered as per individual sites local procedures. The number of Triamcinolone injections, the volume and the site of administration will be documented in the CRF. The initial dose can be split according to local administration procedures. Cycle 1 Day 1 Week 1 (loading dose given once only) o 360 mg IM injection Subsequent cycles (given 4 weekly thereafter until progression +/-3 days) Day 1 o 120 mg IM injection

Sponsors & Collaborators

  • Barts & The London NHS Trust

    lead OTHER

Principal Investigators

  • Jonathan Shamash, MD FRCP · Barts & The London NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-19
Primary Completion
2020-09-24
Completion
2020-09-24

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07161778 on ClinicalTrials.gov