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Clinical Trials/ACTRN12618001640291
ACTRN12618001640291
Recruiting
未知

Additive diagnostic value of prostate specific membrane antigen (PSMA) positron emission tomography (PET) to multiparametric magnetic resonance imaging (mpMRI) in the diagnostic setting: Ability to reduce unnecessary prostate biopsies in men being investigated for prostate cancer.

St Vincent's Hospital0 sites200 target enrollmentOctober 4, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
St Vincent's Hospital
Enrollment
200
Status
Recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 4, 2018
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
St Vincent's Hospital

Eligibility Criteria

Inclusion Criteria

  • Male, aged 18 years or over
  • Suspicion or prostate cancer with either an abnormal DRE OR PSA greater than age specific reference range on two or more occasions
  • No previously diagnosed prostate cancer
  • No previous prostate biopsies
  • Has undergone an mpMRI within the last 6 months, or scheduled to undergo an mpMRI prior to biopsy
  • Ability to give written informed consent, participate in and comply with the study

Exclusion Criteria

  • Previous diagnosis of PCa
  • Previous prostate biopsies
  • Inability/ incapacity to provide own consent
  • PSA \>20ng/ml
  • greater than or equal to cT3 on DRE
  • Contraindication to MRI, including but not restricted to:
  • oPacemaker or other electronic implant
  • oAllergy or contraindiation to MRI contrast, e.g. renal failure (eGFR \<30mL/min)
  • oShrapnel, tattoos, non\-removable body piercings (relative contraindication)

Outcomes

Primary Outcomes

Not specified

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