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A Prospective Study of Hybrid PET/MRI in the Evaluation of Men With Suspected Prostate Cancer Recurrence Following Definitive Local Therapy


N/A
19 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Prospective Study of Hybrid PET/MRI in the Evaluation of Men With Suspected Prostate Cancer Recurrence Following Definitive Local Therapy


The study will be a non-randomized, prospective study of men with suspected local recurrence
of prostate cancer post-prostatectomy with negative bone and CT scans. Hybrid PET/MRI using
18F-FCH will be obtained and a consensus staging report generated for the attending
clinician. Clinical management questionnaires completed by the study investigator will be
obtained pre and post imaging in order to gauge the impact of the hybrid imaging on clinical
decision making.


Inclusion Criteria:



- Prostate cancer with rising prostate specific antigen (PSA) post prostatectomy

- Suspected recurrence based on PSA rise measured on 3 occasions at least 3 months
apart and an absolute PSA > 0.2 ng/mL

- Bone scan and CT scan of the abdomen and pelvis negative for metastatic disease

Exclusion Criteria:

- Evidence of metastatic disease

- Contradiction to 18F-FCH PET scan

- Contraindication to MRI

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Frequency in change of clinical management based on results of 18F-FCH PET/MRI

Outcome Description:

A questionnaire to assess the planned management will be completed by the investigator before and after provision of the results of the 18F-FCH PET/MRI to determine if the information provided by 18F-FCH PET/MRI influences the preferred plan of management

Outcome Time Frame:

Within 2 weeks of study scan

Safety Issue:

No

Principal Investigator

Dr. Glenn S Bauman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

London Health Sciences Centre

Authority:

Canada: Health Canada

Study ID:

IGPC-3

NCT ID:

NCT01804231

Start Date:

April 2013

Completion Date:

March 2017

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • PET
  • MRI
  • Hybrid
  • Recurrence
  • Fluorocholine
  • Prostatic Neoplasms
  • Recurrence

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