Post-radiation Prostate Cancer Local Recurrences: Detection With Histoscanning™ and MRI (HISTO-RAD)

Civil Hospices of Lyon

Status: Completed

Conditions: Prostate Cancer Recurrent

Treatments: Other: Histoscanning™ and multiparametric MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01857037

2010.655

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single arm

Other group

Description:

Single arm

Treatment:

Other: Histoscanning™ and multiparametric MRI