Clinical trial · Interventional
A 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration Resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Triamcinolone acetonide IM injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Triamcinolone
- description
- 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
- interventionNames
- Drug: Triamcinolone acetonide IM injection
Primary outcomes (1)
- measure
- Progression free survival in patients with CRPC
- timeFrame
- 6 months
- description
- To examine whether triamcinolone (IM injection) offers an increased progression free survival (PFS) in patients with confirmed CRPC.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 than 18 5. Patients who are able to understand their participation in the study and give written informed consent 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)
References
Publications (12)
- BACKGROUNDBuchanan G, Yang M, Harris JM, Nahm HS, Han G, Moore N, Bentel JM, Matusik RJ, Horsfall DJ, Marshall VR, Greenberg NM, Tilley WD. Mutations at the boundary of the hinge and ligand binding domain of the androgen receptor confer increased transactivation function. Mol Endocrinol. 2001 Jan;15(1):46-56. doi: 10.1210/mend.15.1.0581. PMID 11145738
- BACKGROUNDMarcelli 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
- BACKGROUNDChang 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
- BACKGROUNDZhao 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
- BACKGROUNDSrinivas 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
- BACKGROUNDOgirala 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
- BACKGROUNDMcGivney 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