A Phase I-II Open Label Clinical Trial, Evaluating the Efficacy and Safety of Administration of the Therapeutic Vaccine PEP-223/CoVaccine HT, to Hormone Treatment naïve, Immunocompetent Subjects With T1-3, N0-1/x, M0 Prostate Cancer, Eligible for Hormone Therapy.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Testosterone suppression
研究概览
简要总结
The purpose of this trial is to investigate whether treatment with this new drug will result in lower testosterone levels in men with prostate cancer. At the same time it will be investigated whether the drug induces side effects, and if so, which ones.
详细描述
Prostate cancer growth is influenced by the male hormone testosterone. Treatment with drugs that stop the production of testosterone often results in a decrease of the tumor or inhibition of its growth. This is particularly important prior to radiotherapy, since radiation can better be focused on the prostate with as a result less frequent or less severe side effects of the radiation.
Most of the drugs used to date to stop the production of testosterone have the disadvantage that initially they may cause a rise of testosterone levels before the production is effectively blocked. The new drug that will be investigated in this trial is a vaccine. The vaccine offers a different treatment modality since it interferes at a different level of the hormonal axis that drives the testosterone production; it will not cause an initial surge.
In this trial the vaccine will be administered three times, testosterone levels will be monitored for a total period of three months.
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •pathological confirmed prostatic adenocarcinoma, clinical stage (c) cT1-3, cN0-1/x, cM0
- •baseline testosterone levels of > 4 nmol/l
- •baseline PSA level of > 10 microg/l
- •eligible for hormone therapy
- •willingness to comply with the protocol conditions and procedures
- •willing and able to give informed consent
排除标准
- •clinical evidence of distant metastases
- •previous hormonal therapy administered specifically for prostatic carcinoma
- •development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
- •primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications
- •concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements
- •concomitant radiotherapy for prostate cancer
- •presence of bacterial prostatitis causing a PSA increase during the 8 weeks preceding study inclusion
- •simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study
- •BMI > 30 kg/square meter
- •previous serious reaction to a vaccine such as angioedema or anaphylaxis
结局指标
主要结局
Testosterone suppression
时间窗: after 12 weeks treatment as compared to baseline
次要结局
- The time course of testosterone suppression(after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline)
- Effects on LH and FSH levels(after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline)
- Effects on PSA levels(after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline)
- Antibody response to PEP223/CoVaccine HT(after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline)
- Safety (adverse events, laboratory values, injection site reactions)(as applicable)