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临床试验/NCT06092918
NCT06092918已完成不适用

Generation and Validation of Predictive Models for Localized Prostate Cancer Treated With External Radiotherapy

Consorci Sanitari de Terrassa0 个研究点目标入组 700 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
700
主要终点
Biochemical recurrence (BR) as an increase of 2 ng/ml or more above the nadir of PSA

研究概览

简要总结

The generation of predictive models in radiotherapy has seen a significant increase. In 2017, Raymond published the largest systematic review of predictive prognostic models for biochemical relapse (BR), metastasis-free survival, and overall survival in patients with localized prostate cancer treated with radiotherapy (14), attempting to identify whether they were adequately developed and validated.

He found 72 unique predictive models for external radiotherapy: 22 corresponding to BR risk, 20 corresponding to Cancer-Specific Survival, 10 corresponding to Overall Survival, and 20 for Disease/Metastasis-Free Survival detection. In his analysis, he highlighted a significant variation in the quality of these predictive models, understanding that they were developed prior to the existence of TRIPOD guidelines.

In this regard, he pointed out that 54% of these models did not report their accuracy, and 61% of the models lacked validation (either internal or external). He also noted that they had limited follow-up (only 65% had follow-up beyond 5 years), that the treatment doses in these models were lower than current standards, and that the radiation techniques were different from current practices. Although in his final assessment, Raymond maintains that predictive models provide more certainty in predicting oncological outcomes than professional assessments, he considers it vital to validate these models for each population that wants to use them (the vast majority of these models are based on U.S. populations) or, even better, to generate predictive models specific to the local population while adhering to the TRIPOD guidelines.

Probably due to the lack of validation in our patients for existing predictive models and/or the absence of predictive models originating from our population, in our routine clinical practice (Multidisciplinary Oncology Committees), phisycians do not apply any predictive models to patients diagnosed with localized prostate cancer.

详细描述

The general objective of the study is to develop a predictive model for oncological outcomes and bladder and rectal toxicities based on the analysis of patients with localized prostate cancer who have received external radiotherapy, useful for medical decision-making. This objective is divided into three specific objectives:

  1. Estimate a predictive model for oncological outcomes, such as the probability of Biochemical Recurrence (BR), Disease-Free or Metastasis-Free Time (DFT), Overall Survival (OS), and Cancer-Specific Survival (CSS).

  2. Estimate a predictive model for bladder and rectal toxicities in patients with localized prostate cancer who have received external radiotherapy.

  3. Analyze the feasibility and impact of implementing an individualized decision-making model based on this model, and its implementation in oncology committees and in initial (informative) visits in radiation oncology.

  • Hypotheses**:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Histological confirmation of prostate adenocarcinoma through biopsy. ECOG (Eastern Cooperative Oncology Group) performance status score <
  • Signed informed consent form.

排除标准

  • Affected lymph nodes or confirmed metastatic disease (bone or lymph node) in prostate cancer based on imaging studies (CT scan, bone scan, MRI).
  • Anticoagulant therapy, individual evaluation of antiplatelet therapy. Prior pelvic radiotherapy. Prior surgery for prostate cancer. Personal history of Crohn's disease or ulcerative colitis.

结局指标

主要结局

Biochemical recurrence (BR) as an increase of 2 ng/ml or more above the nadir of PSA

时间窗: 5-10 years

2 ng/ml + nadir

Overall Survival (OS)

时间窗: 5-10 years

As the time in months from diagnosis until death or the last follow-up.

次要结局

  • Grade II toxicity in bladder and rectal(5-10 years)

研究者

发起方
Consorci Sanitari de Terrassa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas Feltes

M.D

Consorci Sanitari de Terrassa

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