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


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer Recurrent

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Trial Information

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

- IRB-approved informed consent signed

Exclusion Criteria:

- Contraindication to MRI

- Contraindication to endorectal examination

- Contraindication to prostate biopsy

- History of allergy to gadolinium chelates

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Olivier Rouvière, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospices Civiles de Lyon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2010.655

NCT ID:

NCT01857037

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Prostate Cancer Recurrent
  • Prostatic Neoplasms
  • Recurrence

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