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OpenTrials
Completed

NCT Number: NCT01857037

Post-radiation Prostate Cancer Local Recurrences: Detection With Histoscanning™ and MRI

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

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Key information

Conditions

Prostate Cancer Recurrent

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prof O. ROUVIERE

Lyon, Rhône, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • IRB-approved informed consent signed

Exclusion criteria

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

Treatment and study plan

Histoscanning™ and multiparametric MRI

Other

Detection and localization of prostate cancer local recurrences after radiation therapy using Histoscanning™ and multiparametric MRI

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 1 day

    MRI 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 MRI to correctly identify the presence or absence of cancer into prostate sextants.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: HISTO-RAD

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 20, 2013
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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