Prospective trial assessing the additive diagnostic value of 68Ga-PSMA positron emission tomography (PSMA-PET) in men scheduled to undergo diagnostic biopsy for suspicion of prostate cancer.

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Surgery - Other surgery; Cancer - Prostate

• Registration Number: ACTRN12618001640291
• Lead Sponsor: St Vincent's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-04
• Last Update Posted: 22 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 200

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified