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临床试验/NCT06145958
NCT06145958尚未招募不适用

A Translational Study of Samples From the Radiotherapy and Androgen Deprivation In Combination After Local Surgery (RADICALS) Prostate Cancer Trial to Identify Those Most Likely to Benefit From Androgen Deprivation With Salvage Radiotherapy

University College, London0 个研究点目标入组 2,585 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,585
主要终点
Freedom from Distant Metastases

研究概览

简要总结

The goal of this translational study is to test the use of biomarkers in salvage treatment for prostate cancer after a previous operation to remove the prostate. The main question it aims to answer is:

• Can a biomarker identify a group of patients most likely to benefit from androgen deprivation therapy in conjunction with salvage radiotherapy No new participants will be involved, but tumour samples will be acquired, for patients that gave their permission in the completed RADICALS RT and HD studies.

详细描述

Early prostate cancer represents a wide spectrum of disease. Indolent disease is unlikely to ever become symptomatic and treatment is needlessly morbid and costly. Aggressive disease warrants intensification of therapy. Current clinical methods are poor at discriminating these outcomes.

The RADICALS trial was the largest trial conducted to date in men requiring further curative treatment after an operation. It already defined the role for radiotherapy after surgery (prostatectomy). The standard of care is now for blood test (PSA) monitoring after prostatectomy with radiotherapy offered when the PSA rises. The role and duration of hormone treatment (androgen deprivation), given in combination with radiotherapy, remains less clear. Currently if androgen deprivation is to be given, the RADICALS data support the use of a 24-month course, but this entails a considerable burden of side-effects for patients. Pathological and biological markers are needed to identify those most likely to benefit from androgen deprivation.

In RADICALS-TR, the investigators will conduct translational analyses on the biopsy and prostatectomy specimens from the RADICALS trial. The investigators aim to identify prognostic features and biomarkers predictive of benefit from androgen therapy. The investigators will prioritise the refinement and validation of clinical biomarkers already close to clinical utilisation. In this way it is hoped that findings can rapidly translate to stratified clinical trials and improved patient care.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Short course androgen deprivation

Those patients given 6 months of androgen deprivation therapy

干预措施: Luteinising Hormone-Releasing Factor Analogue (Drug)

Long course androgen deprivation

Those patients given 24 months of androgen deprivation therapy

干预措施: Luteinising Hormone-Releasing Factor Analogue (Drug)

结局指标

主要结局

Freedom from Distant Metastases

时间窗: Up to 12 years

The absence of prostate cancer metastases

次要结局

  • Freedom from treatment failure(Up to 12 years)
  • Clinical Progression Free survival(Up to 12 years)
  • Non protocol hormone therapy(Up to 12 years)
  • Freedom from biochemical progression(Up to 12 years)
  • Overall survival(Up to 12 years)
  • Disease Specific Survival(Up to 12 years)

研究者

申办方类型
Other
责任方
Sponsor

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