跳至主要内容
临床试验/NCT01883128
NCT01883128Unknown2 期

An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.

University College London Hospitals4 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2014年4月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
177
试验地点
4
主要终点
Accuracy of whole body MRI in identifying distant disease

研究概览

简要总结

Radiotherapy is the commonest form of prostate cancer treatment in the UK. In one in four men, radiotherapy will fail to control the cancer. These men are offered hormonal treatment which has significant side effects. Few men are offered a further treatment such as surgery, HIFU or cryotherapy. Only half of these men are cancer free at 5 years. The investigators believe this is due to poor imaging tests such as CT and Bone scan that cannot accurately detect whether cancer has come back inside or outside of the prostate or both. Also radiotherapy damages tissue surrounding the prostate which affects tissue healing for example after surgery. Treating just the cancer in the prostate only (focal treatment) rather than the whole prostate may limit this damage and cause fewer side-effects. The investigators want to see if new imaging tests can better identify cancer that has spread outside of the prostate and areas of cancer inside the prostate. Our new tests are whole-body MRI (for distant disease) and MRI guided biopsies (MRI-TB) (for local disease). First, the investigators will compare the results of whole-body MRI to existing imaging tests (bone-scan, and choline PET/CT) that try to find distant spread. Second, the investigators will compare the results of MRI-TB to a very detailed and accurate biopsy of the prostate called template prostate mapping which will show us where and how aggressive the cancer is. Third, if the cancer is confined to the prostate, the investigators will treat men using focal salvage therapies HIFU and cryotherapy. The investigators believe that these new imaging tests could better identify those who will benefit from early hormone treatment and those who will benefit from local salvage treatment. Our study may help justify carrying out a larger trial looking at how good the treatment is in controlling cancer in the medium and long-term.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

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

入选标准

  • Previous external beam radiotherapy with or without neo-adjuvant/adjuvant hormone therapy
  • Biochemical failure as defined by the Phoenix criteria (PSA nadir + 2ng/ml)
  • Men considering local salvage treatment for radio-recurrent disease
  • Life expectancy of 5 years or more

排除标准

  • Have taken any form of hormones (except 5-alpha reductase inhibitors) within the previous 6 months
  • Unable to have MRI scan as defined by standard care practice
  • Metallic implant likely to cause artefact and reduce scan quality
  • PSA doubling time of 3 months or less
  • PSA value 20ng/ml or greater
  • Prior prostate biopsies following biochemical failure
  • Any prior local intervention to the prostate (e.g., laser/electrical resection or incision, cryotherapy, HIFU, any other ablative modality, any other radiotherapy, any other prostate injection therapy for symptoms or cancer control)
  • Unable to have general or regional anaesthesia
  • Unable to give informed consent

结局指标

主要结局

Accuracy of whole body MRI in identifying distant disease

时间窗: 2 years

Whole body MRI lesions suspicious of lymph node, visceral or bone metastases compared to standard care tests \- Sensitivity, specificity, negative and positive predictive values of whole-body MRI to detect distant disease compared to standard care tests (isotope bone-scan, PET/CT-scan, with skeletal survey where appropriate) and/or pelvic lymphadenectomy and/or biopsy of distant areas in indeterminate cases

次要结局

  • Can multiparametric MRI accurately detect localised recurrent prostate cancer(2 years)

研究者

发起方
University College London Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hashim Uddin Ahmed

MRC Clinician Scientist and Clinical Lecturer in Urology

University College London Hospitals

研究点 (4)

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