A prospective single arm paired comparison of ability to locate and diagnose prostate cancer between multiparametric MRI, PSMA-PET/CT AND PSMA-PET MRI fusio

Phase 3

• Conditions: Patients with features suspicious for prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12620000261910
• Lead Sponsor: Mr Lih-Ming Wong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-27
• Last Update Posted: 10 March 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Men (greater to or equal than 18 years) with an elevated PSA who are suitable for an eligible MBS mpMRI prostate (MBS items 63541 and 63542 NK)
2. For MBS items 63541 and 63542 (NK) the patient must be suspected of having prostate cancer based on (*):
a) a digital rectal examination (DRE) which is suspicious for prostate cancer; or
b) in a person aged less than 70 years, at least two prostate specific antigen (PSA) tests performed within an interval of 1- 3 months are greater than 3.0 ng/ml, and the free/total PSA ratio is less than 25% or the repeat PSA exceeds 5.5 ng/ml; or
c) in a person aged less than 70 years, whose risk of developing prostate cancer based on family history is at least double the average risk, at least two PSA tests performed within an interval of 1-3 months are greater than 2.0 ng/ml, and the free/total PSA ratio is less than 25%; or
d) in a person aged 70 years or older, at least two PSA tests performed within an interval of 1-3 months are greater than 5.5ng/ml and the free/total PSA ratio is less than 25%. NB: Relevant family history is a first degree relative with prostate cancer or suspected of carrying a BRCA 1, BRCA 2 mutation.
(*)http://www.mbsonline.gov.au/internet/mbsonline/publishing.nsf/Content/Factsheet-MRIProstate
3. Patient has provided written informed consent for participation in trial
4. In the opinion of the investigator, willing and able to comply with required study procedures

Exclusion Criteria

1. Known diagnosis of prostate cancer.
2. Previous prostate biopsy within 3 years of recruitment. A transurethral resection of the prostate performed for primary purpose of alleviating lower urinary tract symptoms is considered acceptable.
3. Previous mpMRI prostate within 3 years of recruitment.
4. History of other active malignancy within the last 3 years, with the exception of nonmelanoma skin cancer or melanoma in-situ.
5. Any absolute contra-indication to 3T mpMRI prostate, or previous history of total hip joint replacement.
6. Significant intercurrent morbidity that, in the judgement of the investigator, would limit compliance with study protocols

Study & Design

• Study Type: Interventional
• Study Design: Not specified