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临床试验/NCT01857037
NCT01857037已完成不适用

Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Evaluation of Histoscanning™ after radiation therapy in comparison to random and targeted biopsy.

研究概览

简要总结

Inclusion criteria:

  • Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR
  • Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)

Study Design:

  • Included patients will undergo an endorectal US examination with a Histoscanning™ acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic contrast-enhanced) MRI.
  • Two independent operators will separately define suspicious focal lesion on Histoscanning™ images and on MR images.
  • Random biopsies (at least 2 cores) will be performed in sextants negative at Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI, targeted biopsies will be performed in the suspicious part of the sextant (at least two cores per suspicious lesion).
  • Histoscanning™ and MRI results will be compared to biopsy results.

A total of 30 patients will be included

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)
  • •IRB-approved informed consent signed

排除标准

  • •Contraindication to MRI
  • •Contraindication to endorectal examination
  • •Contraindication to prostate biopsy
  • •History of allergy to gadolinium chelates

研究组 & 干预措施

Single arm

Other

Single arm

干预措施: Histoscanning™ and multiparametric MRI (Other)

结局指标

主要结局

Evaluation of Histoscanning™ after radiation therapy in comparison to random and targeted biopsy.

时间窗: 1 day

Histoscanning and biopsy findings will be compared on a sextant by sextant basis. A mixed effects logistic regression model (with fixed and random effects) will be used to model the sensitivity and specificity of Histoscanning to correctly identify the presence or absence of cancer into prostate sextants.

次要结局

  • Evaluation of multiparametric MRI after radiation therapy in comparison to random and targeted biopsy.(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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