CONFIRM: The Diagnostic Utility of Prostate Specific Membrane Antigen Positron Emission Tomography/Computed tomography (PSMA PET/CT) in Men with Newly Diagnosed Low-Grade Prostate Cancer with High-Risk Features, on Active Surveillance (regular testing for any changes in the cancer that could lead to harm), Awaiting Confirmatory Biopsy

Not Applicable

Recruiting

• Conditions: prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12621001648819
• Lead Sponsor: EJ Whitten Foundation Prostate Cancer Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-01
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 223

Inclusion Criteria

Any man, 18-years and over who has undergone prostate biopsy with a new diagnosis of prostate cancer, being managed through active surveillance, with one or more of the following 'high-risk features':

- GG2 cancers where the amount of pattern 4 is 10% or less
- GG1 cancers which are considered to be high volume
- GG1 cancers that have PIRADS 4 or 5 lesion on the MRI
- Low volume GG1 cancer but has a high PSA

Exclusion Criteria

- A history of other active malignancy within the last 5 years, with exception of non-melanoma skin cancer
- A known history of prostate cancer
- A diagnostic prostate biopsy of more than 6 months prior
- Contra-indication to 3T mpMRI or PSMA PET/CT
- Significant intercurrent morbidity limiting compliance with study protocols

Study & Design

• Study Type: Interventional
• Study Design: Not specified