Castration Resistant Prostate CancerPhase 2TRICRESTNCT07161778
A Trial of Triamcinolone With a GnRH Analog for Castration Resistant Prostate Cancer
A Phase 2 study testing Triamcinolone acetonide IM injection in people with Castration Resistant Prostate Cancer, run by Barts & The London NHS Trust at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration Resistant Prostate Cancer
- What is being tested?
- Triamcinolone acetonide IM injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 19 Oct 2011to 24 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Royal Sussex County Hospital
Brighton
Raigmore Hospital
Inverness
St Bartholomew's Hospital
London
About this study
Official title: A Phase II Single Arm, Multi-centre Trial of Triamcinolone With a GnRH Analog for Castration Resistant Prostate Cancer
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.
Read more
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
Read the detailed description
Castration resistant prostate cancer (CRPC) is a cancer which has become resistant to hormone therapy. Triamcinolone is a steroid drug, and it is hoped that when administered intra-muscularly with a gonadotropin-releasing hormone (GnRH) analog, it will reduce the tumours' ability to grow and thus improve the therapy response rate.
This is a single arm, multi-centre phase II trial and it follows a Simon Two-stage minimax design based on the progression free survival rate at 6-months. A total of 41 patients will be recruited to the study. Following recruitment of the first 17 patients; an interim analysis will take place, and at least 7 of these will be required to have survived progression free, at 6 months in order to proceed to the 2nd stage of the trial. During the 2nd stage, if 20 or more patients out of the total 41 have survived progression free, then the drug will be developed further at a randomized phase II or phase III trial.
Patients will receive monthly treatment of intramuscular triamcinolone and GnRH up until treatment failure (progression, toxicity or death) and survival information will then be collected.
Patients will be identified through referrals and at multidisciplinary team meetings (MDTs). Eligible patients will be approached by members of the research team at outpatient clinic appointments. To be registered, the trial patients must satisfy all aspects of the eligibility criteria.
Once an eligible patient is identified and prior to their participation in this study, the Investigator, or a person delegated by the Investigator will adequately explain the aims, methods, anticipated benefits, potential hazards, and relay the fact that should new safety information result in significant changes in the risk or benefit, study patients will be notified. The Investigator, or a person delegated by the Investigator must also explain to the patient that they are completely free to refuse to enter the study or to withdraw at any time during the study. The patient will be sent away with a patient information sheet and will be given at least 24 hours to consider study participation.
If the eligible patient is satisfied and fully understands what the study entails and what is expected, written informed consent will be obtained and the patient will be registered into the trial. A blood test will be taken at 9am in the morning; the equivalent of 3 teaspoons of blood will be removed. The blood test will be used to assess blood circulating tumour cells (CTC), toxicity tumour markers, and the levels of cortisol and protein specific antigen (PSA is a chemical prostate cancer produces). A full history will be taken, and the patient will be examined. A bone scan performed prior to study participation as part of standard practice will also be assessed, providing it is not dated beyond a maximum of 6 weeks prior to the start of trial treatment. The inclusion and exclusion criteria will be verified once more.
One day one, week one of treatment, the patient will be asked to return a 24 hour urine collection sample ( in order to obtain a profile of urinary steroids). The patient will receive an initial loading dose of 360 mg of triamcinolone, this will be administered over 3 injections (3 x 120 mg) into the muscle in the patient's buttocks. On day one, week four of treatment, the patient will receive only one injection of 120 mg IM of triamcinolone, and thereafter there will be one injection per treatment visit, four weekly until progression (as per day one, week four of treatment).
Depending on the GnRH analog treatment the patient was on prior to the start of the trial, either 4 weekly or 12 weekly, it will remain the same for the duration of the patient's participation in the trial. The GnRH analog can be administered by their local GP as custom or if they are due receive the GnRH analog and triamcinolone at the same time, both will be administered at the site. However triamcinolone can be administered at the site only.
The patient will be monitored with a follow up phone call from a nurse within a week following the first loading dose of triamcinolone, to see how the patient is and to check if there are any side-effects of the treatment.
Three weeks following the start of treatment a blood test and 24-hour urine collection will be repeated. This is to assess whether the cancer is responding to treatment. These tests are also scheduled to be performed when the patient attends 4 weekly for triamcinolone treatment, however the doctor may request further tests depending on how the patient is responding to treatment. In particular, if PSA increases significantly while on treatment, the doctor may then decide to stop triamcinolone treatment and inform the patient of alternative treatment options. Following treatment failure, patients will be followed up every 3 months and permission will be sought to obtain patient survival data when they return to standard care appointments.
An additional aspect of the study which is optional depending on the site and the patient is the translational research component:
Provided the patient has not withheld consent, a blood sample will be taken at the start of the trial, following registration and another sample when treatment fails due to progression, which will then be used to analyse DNA mutations.
- Conditions
- Castration Resistant Prostate Cancer
- Being tested
- Triamcinolone acetonide IM injection
- Keywords
- CRPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonide IM injectionDrug
Also called Kenalog Intra-articular / Intramuscular 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)
- 360 mg IM injection
Subsequent cycles (given 4 weekly thereafter until progression +/-3 days)
Day 1
- 120 mg IM injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Triamcinolone acetonide IM injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Time to PSA progression according to PCWG2
Serum collected will be tested for PSA progression
Measured: 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
Comparing CTC at baseline to 28 days
Measured: Circulating Tumour Cells results at baseline and taken 28 days post baseline will be compared
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start19 Oct 2011
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Castration Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Shamash, MD FRCP, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161778
- Sponsor's protocol ID
- 7664
- Other IDs
- 2010-022010-32
- Acronym
- TRICREST
- Status last verified
- Sep 2025
- First submitted
- 21 Oct 2014
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Buchanan 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.
PubMed 11145738Marcelli 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.
PubMed 10706109Chang 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.
PubMed 11751389Zhao 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.
PubMed 10835690Srinivas 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.
PubMed 16698360Ogirala 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.
PubMed 2021388McGivney 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.
PubMed 8114514Veldscholte 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.
PubMed 1562539Ross 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.
PubMed 18281655Scher 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.
PubMed 18309951Shamash 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.
PubMed 21285990Simon 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.
PubMed 2702835
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single Arm, Multi-centre Trial of Triamcinolone With a GnRH Analog for Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07161778
- Acronym / sponsor ID
- TRICREST / 7664
- Conditions
- Castration Resistant Prostate Cancer
- Keywords
- CRPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 19 Oct 2011 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Castration resistant prostate cancer (CRPC) is a cancer which has become resistant to hormone therapy. Triamcinolone is a steroid drug, and it is hoped that when administered intra-muscularly with a gonadotropin-releasing hormone (GnRH) analog, it will reduce the tumours' ability to grow and thus improve the therapy response rate.
This is a single arm, multi-centre phase II trial and it follows a Simon Two-stage minimax design based on the progression free survival rate at 6-months. A total of 41 patients will be recruited to the study. Following recruitment of the first 17 patients; an interim analysis will take place, and at least 7 of these will be required to have survived progression free, at 6 months in order to proceed to the 2nd stage of the trial. During the 2nd stage, if 20 or more patients out of the total 41 have survived progression free, then the drug will be developed further at a randomized phase II or phase III trial.
Patients will receive monthly treatment of intramuscular triamcinolone and GnRH up until treatment failure (progression, toxicity or death) and survival information will then be collected.
Patients will be identified through referrals and at multidisciplinary team meetings (MDTs). Eligible patients will be approached by members of the research team at outpatient clinic appointments. To be registered, the trial patients must satisfy all aspects of the eligibility criteria.
Once an eligible patient is identified and prior to their participation in this study, the Investigator, or a person delegated by the Investigator will adequately explain the aims, methods, anticipated benefits, potential hazards, and relay the fact that should new safety information result in significant changes in the risk or benefit, study patients will be notified. The Investigator, or a person delegated by the Investigator must also explain to the patient that they are completely free to refuse to enter the study or to withdraw at any time during the study. The patient will be sent away with a patient information sheet and will be given at least 24 hours to consider study participation.
If the eligible patient is satisfied and fully understands what the study entails and what is expected, written informed consent will be obtained and the patient will be registered into the trial. A blood test will be taken at 9am in the morning; the equivalent of 3 teaspoons of blood will be removed. The blood test will be used to assess blood circulating tumour cells (CTC), toxicity tumour markers, and the levels of cortisol and protein specific antigen (PSA is a chemical prostate cancer produces). A full history will be taken, and the patient will be examined. A bone scan performed prior to study participation as part of standard practice will also be assessed, providing it is not dated beyond a maximum of 6 weeks prior to the start of trial treatment. The inclusion and exclusion criteria will be verified once more.
One day one, week one of treatment, the patient will be asked to return a 24 hour urine collection sample ( in order to obtain a profile of urinary steroids). The patient will receive an initial loading dose of 360 mg of triamcinolone, this will be administered over 3 injections (3 x 120 mg) into the muscle in the patient's buttocks. On day one, week four of treatment, the patient will receive only one injection of 120 mg IM of triamcinolone, and thereafter there will be one injection per treatment visit, four weekly until progression (as per day one, week four of treatment).
Depending on the GnRH analog treatment the patient was on prior to the start of the trial, either 4 weekly or 12 weekly, it will remain the same for the duration of the patient's participation in the trial. The GnRH analog can be administered by their local GP as custom or if they are due receive the GnRH analog and triamcinolone at the same time, both will be administered at the site. However triamcinolone can be administered at the site only.
The patient will be monitored with a follow up phone call from a nurse within a week following the first loading dose of triamcinolone, to see how the patient is and to check if there are any side-effects of the treatment.
Three weeks following the start of treatment a blood test and 24-hour urine collection will be repeated. This is to assess whether the cancer is responding to treatment. These tests are also scheduled to be performed when the patient attends 4 weekly for triamcinolone treatment, however the doctor may request further tests depending on how the patient is responding to treatment. In particular, if PSA increases significantly while on treatment, the doctor may then decide to stop triamcinolone treatment and inform the patient of alternative treatment options. Following treatment failure, patients will be followed up every 3 months and permission will be sought to obtain patient survival data when they return to standard care appointments.
An additional aspect of the study which is optional depending on the site and the patient is the translational research component:
Provided the patient has not withheld consent, a blood sample will be taken at the start of the trial, following registration and another sample when treatment fails due to progression, which will then be used to analyse DNA mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone | Experimental | Drug: Triamcinolone acetonide IM injectionAn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone acetonide IM injectionAlso: Kenalog Intra-articular / Intramuscular InjectionAn 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 |
Primary outcome
Progression free survival in patients with CRPC
Time frame: 6 months
To examine whether triamcinolone (IM injection) offers an increased progression free survival (PFS) in patients with confirmed CRPC.
2 secondary outcomes
Time to PSA progression according to PCWG2
Time frame: 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
Time frame: Circulating Tumour Cells results at baseline and taken 28 days post baseline will be compared
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Background: PubMed 11145738Buchanan 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.
- Background: PubMed 10706109Marcelli 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.
- Background: PubMed 11751389Chang 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.
- Background: PubMed 10835690Zhao 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.
- Background: PubMed 16698360Srinivas 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.
- Background: PubMed 2021388Ogirala 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.
- Background: PubMed 8114514McGivney 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.
- Background: PubMed 1562539Veldscholte 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.
- Background: PubMed 18281655Ross 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.
- Background: PubMed 18309951Scher 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.
- Background: PubMed 21285990Shamash 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.
- Background: PubMed 2702835Simon 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.
- Related InfoLink provided by the sponsor.
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Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Shamash, MD FRCP principal investigator
Barts & The London NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triamcinolone acetonide IM injection in people with Castration Resistant Prostate Cancer, run by Barts & The London NHS Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival in patients with CRPC (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07161778, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.