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

NCT07161778 | Completed Phase 2

• 2 other identifiers: 76642010-022010-32
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

CRPC

Outcome Measures

Primary Outcomes (1)

• Progression free survival in patients with CRPC

  To examine whether triamcinolone (IM injection) offers an increased progression free survival (PFS) in patients with confirmed CRPC.

  6 months

Secondary Outcomes (2)

• Time to PSA progression according to PCWG2

  Measured at the beginning of every treatment cycle (Time to PSA progression from baseline - 6 month)

• Circulating Tumour Cells response in patients after 28 days of treatment

  Circulating Tumour Cells results at baseline and taken 28 days post baseline will be compared

Study Arms (1)

Triamcinolone

EXPERIMENTAL

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

Drug: Triamcinolone acetonide IM injection

Interventions

Triamcinolone acetonide IM injection DRUG

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

Also known as: Kenalog Intra-articular / Intramuscular Injection

Triamcinolone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate
• 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)
• ECOG performance status (PS) 0-3 and considered by responsible consultant suitable to undergo treatment
• Males aged greater or equal than 18
• Patients who are able to understand their participation in the study and give written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (3)

Royal Sussex County Hospital

Brighton, United Kingdom

Location

Raigmore Hospital

Inverness, United Kingdom

Location

St Bartholomew's Hospital

London, United Kingdom

Location

Related Publications (12)

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  PMID: 11145738 BACKGROUND

• Marcelli M, Ittmann M, Mariani S, Sutherland R, Nigam R, Murthy L, Zhao Y, DiConcini D, Puxeddu E, Esen A, Eastham J, Weigel NL, Lamb DJ. Androgen receptor mutations in prostate cancer. Cancer Res. 2000 Feb 15;60(4):944-9.

  PMID: 10706109 BACKGROUND

• Chang CY, Walther PJ, McDonnell DP. Glucocorticoids manifest androgenic activity in a cell line derived from a metastatic prostate cancer. Cancer Res. 2001 Dec 15;61(24):8712-7.

  PMID: 11751389 BACKGROUND

• Zhao XY, Malloy PJ, Krishnan AV, Swami S, Navone NM, Peehl DM, Feldman D. Glucocorticoids can promote androgen-independent growth of prostate cancer cells through a mutated androgen receptor. Nat Med. 2000 Jun;6(6):703-6. doi: 10.1038/76287.

  PMID: 10835690 BACKGROUND

• Srinivas S, Krishnan AV, Colocci N, Feldman D. Phase II study evaluating oral triamcinolone in patients with androgen-independent prostate cancer. Urology. 2006 May;67(5):1001-6. doi: 10.1016/j.urology.2005.11.004.

  PMID: 16698360 BACKGROUND

• Ogirala RG, Aldrich TK, Prezant DJ, Sinnett MJ, Enden JB, Williams MH Jr. High-dose intramuscular triamcinolone in severe, chronic, life-threatening asthma. N Engl J Med. 1991 Feb 28;324(9):585-9. doi: 10.1056/NEJM199102283240903.

  PMID: 2021388 BACKGROUND

• McGivney SA, Ogirala RG. Effect of high-dose intramuscular triamcinolone in older adults with severe, chronic asthma. Lung. 1994;172(2):73-8. doi: 10.1007/BF00185078.

  PMID: 8114514 BACKGROUND

• Veldscholte J, Berrevoets CA, Ris-Stalpers C, Kuiper GG, Jenster G, Trapman J, Brinkmann AO, Mulder E. The androgen receptor in LNCaP cells contains a mutation in the ligand binding domain which affects steroid binding characteristics and response to antiandrogens. J Steroid Biochem Mol Biol. 1992 Mar;41(3-8):665-9. doi: 10.1016/0960-0760(92)90401-4.

  PMID: 1562539 BACKGROUND

• Ross RW, Oh WK, Xie W, Pomerantz M, Nakabayashi M, Sartor O, Taplin ME, Regan MM, Kantoff PW, Freedman M. Inherited variation in the androgen pathway is associated with the efficacy of androgen-deprivation therapy in men with prostate cancer. J Clin Oncol. 2008 Feb 20;26(6):842-7. doi: 10.1200/JCO.2007.13.6804.

  PMID: 18281655 BACKGROUND

• Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.

  PMID: 18309951 BACKGROUND

• Shamash J, Powles T, Sarker SJ, Protheroe A, Mithal N, Mills R, Beard R, Wilson P, Tranter N, O'Brien N, McFaul S, Oliver T. A multi-centre randomised phase III trial of Dexamethasone vs Dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred Diethylstilbestrol. Br J Cancer. 2011 Feb 15;104(4):620-8. doi: 10.1038/bjc.2011.7. Epub 2011 Feb 1.

  PMID: 21285990 BACKGROUND

• Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.

  PMID: 2702835 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Triamcinolone Acetonide; Injections, Intramuscular

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jonathan Shamash, MD FRCP

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: September 9, 2025
• Study Start: October 19, 2011
• Primary Completion: September 24, 2020
• Study Completion: September 24, 2020
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

GB (3)