A Non-interventional Study of Postoperative or Post-Radiation trEatment Habits in Locally adVanced Prostate Cancer patiENTs (High Risk)- PREVENT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration
研究概览
简要总结
This is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including "go" / "no go" decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in Russia.
详细描述
This is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including "go" / "no go" decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in Russia.
No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
It is planned to enrol 200 subjects in up to 30 sites in Russian Federation. The average number of patients per site is planned as 6 - 10; there are no restrictions on minimum and maximum number of subjects per site in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The voluntarily given informed consent, confirmed by the Informed Consent Form, properly signed by both the subject and the investigator.
- •Locally advanced stage of PCa (stage T3-T4, Nx-N0, M0: prostate adenocarcinoma with extracapsular invasion (T3a) or invasion to the seminal vesicles (T3b), invasion to adjacent structures (T4) but without lymphatic invasion (N0) nor metastasis (M0))
- •Prostatectomy or radiotherapy completed within 3 months prior to the study enrolment
- •High (T3a or Gleason score = 8-10 or PCA >20 ng/ml) and very high (T3b-T4) risk of recurrence
- •Histologically confirmed diagnosis of prostate adenocarcinoma
排除标准
- •Patients participating in clinical trials
- •Any medical condition which on the opinion of the investigator may interfere with the patient's participation in the study, e.g. severe non-malignant concomitant disease which can affect life expectancy
- •Evidence of metastatic disease on imaging studies
结局指标
主要结局
Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration
时间窗: up to 15 months after LSI
Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration
次要结局
- Evaluation of deaths among BRCAm+ patient(up to 15 months after LSI)
- Data collection of patients characteristics (age, race, co-morbidities, family history of prostate cancer)(up to 15 months after LSI)
- Data collection of disease information ( disease stage - TNM, histology, Gleason score, PSA level, prior prostate cancer surgery/radiotherapy -types, imaging techniques, neoadjuvant and adjuvant therapy(medications by groups, orchidectomy)(up to 15 months after LSI)
- Proportion of patients having biochemical relapse after 1 year follow-up(up to 15 months after LSI)
- Proportion of patients having clinical relapse (local or metastatic) after 1 year follow-up(up to 15 months after LSI)
- Proportion of patients with double increase in PSA level during 1 year follow-up(up to 15 months after LSI)
- Proportion of progression-free patients after 1 year follow-up(up to 15 months after LSI)
- Proportion of patients with disease progression after 1 year follow-up(up to 15 months after LSI)