A Prospective Comparison of fluorine- and gallium-labelled Prostate Specific Membrane Antigen (PSMA) radiotracers, using Positron Emission Tomography (PET-CT), in primary and suspected recurrent Prostate Cancer (PSMA-PET-PROFILE)

Phase 2

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12619000460101
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Last Update Posted: 5 October 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 140

Inclusion Criteria

1)be >= 18 years of age
2)have a confirmed diagnosis of prostate cancer from:
a)a biopsy-confirmed diagnosis of prostate cancer;
b)suspected recurrent prostate cancer after primary treatment; there is no study-specific PSA threshold value for biochemical recurrence, but rather the assessment of suspected recurrence is left to the referring Dr;
3)have a management question, for which a PSMA PET-CT scan is indicated and,
4)be willing to have two PET-CT scans on separate days.

Exclusion Criteria

1)unable to provide written informed consent for the study and,
2)unable to lie flat for the scans

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the number of lesions detected with each PET tracer, and overlap of the detected sites of disease.[50 minutes following injection of the 68Ga-PSMA tracer; 180 minutes following injection of the 18F-PSMA tracer.];SUVmax of lesions detected by each scanning modality[50 minutes following injection of the 68Ga-PSMA tracer; 180 minutes following injection of the 18F-PSMA tracer.]

Secondary Outcome Measures

Name	Time	Method
Sensitivity/specificity of lesion detection for each imaging modality. Where available, for patients who undergo subsequent lymph node dissection, lesions detected on each scan will be compared to lesions detected pathologically. These will be categorised as false positive/negative or true positive/negative, to determine specificity and sensitivity.[Lymph node dissections within 3 months after scanning.];Examine the kinetics of 18F-PSMA uptake in the kinetics subcohort of patients, by measurement of tracer uptake (SUVmax) of lesions and organs (bladder, liver, kidneys) over time (1h, 2h, 3h after tracer injection), as measured on each PET scan.[60, 120, and 180 minutes following injection of the 18F-PSMA tracer]