A Phase II Single Arm, Multi-centre Trial of Triamcinolone With a GnRH Analog for Castration Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Progression free survival in patients with CRPC
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Triamcinolone
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
干预措施: Triamcinolone acetonide IM injection (Drug)
结局指标
主要结局
Progression free survival in patients with CRPC
时间窗: 6 months
To examine whether triamcinolone (IM injection) offers an increased progression free survival (PFS) in patients with confirmed CRPC.
次要结局
- 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)