NCT01857037

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 3, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

March 28, 2012

Last Update Submit

September 1, 2025

Conditions

Prostate Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 day

Secondary Outcomes (1)

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

    1 day

Study Arms (1)

Single arm

OTHER

Single arm

Other: Histoscanning™ and multiparametric MRI

Interventions

Histoscanning™ and multiparametric MRIOTHER

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

Single arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof O. ROUVIERE

Lyon, Rhône, 69437, France

Location

Related Publications (1)

  • Alonzo F, Melodelima C, Bratan F, Vitry T, Crouzet S, Gelet A, Rouviere O. Detection of locally radio-recurrent prostate cancer at multiparametric MRI: Can dynamic contrast-enhanced imaging be omitted? Diagn Interv Imaging. 2016 Apr;97(4):433-41. doi: 10.1016/j.diii.2016.01.008. Epub 2016 Feb 23.

    PMID: 26928245BACKGROUND

Study Officials

  • Olivier Rouvière, Pr

    Hospices Civiles de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2012

First Posted

May 20, 2013

Study Start

May 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 3, 2025

Record last verified: 2025-09

Locations

FR(1)