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Clinical Trials/ACTRN12614000783628
ACTRN12614000783628
Recruiting
Phase 3

Evaluation of Multiparametric Magnetic Resonance Imaging and Positron Emission Tomography with a [68Ga]gallium-labelled prostate-specific membrane antigen (PSMA) ligand for the Detection of Multiple Cancer Foci in Localized Prostate Cancer Patients – A Pilot Study

Queensland University of Technology0 sites20 target enrollmentJuly 22, 2014
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Conditionsocalized Prostate CancerLocalized Prostate CancerCancer - Prostate

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
ocalized Prostate Cancer
Sponsor
Queensland University of Technology
Enrollment
20
Status
Recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 22, 2014
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Male patients pathologically diagnosed with localized prostate cancer, awaiting prostatectomy
  • •2\. The time interval between last prostate biopsy and planned MP\-MRI or planned 68Ga\- HBED\-CC PET must be not less than 8 weeks
  • •3\. No known problems with peripheral intravenous or central line access
  • •4\. Able to provide informed signed consent

Exclusion Criteria

  • •1\. Age under 18 years
  • •2\. Prior pelvic external beam radiation therapy or brachytherapy, prior chemotherapy, prior hormonal or radiation therapy for prostate cancer
  • •3\. Administered a radioisotope within 5 physical half\-lives prior to study enrolment
  • •4\. Treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
  • •5\. Hemorrhagic cystitis or active prostatitis
  • •6\. Unable to lie flat during or unable to tolerate MP MRI or PET
  • •7\. Prior history of any other malignancy within last 2 years
  • •8\. Contraindication to MRI or MRI contrast agent or PET scan or \[68Ga]gallium\-labelled PSMA ligand
  • •9\. Claustrophobia not manageable by oral sedatives ie Temazepam
  • •10\. Moderate to severe rectal inflammation

Outcomes

Primary Outcomes

Not specified

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