A prospective study to assess the diagnostic accuracy and management impact of Prostate Specific Membrane Antigen (PSMA) PET scanning in men with prostate cancer being considered for surgery or radiotherapy.

Not Applicable

Completed

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12617000005358
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-03
• Study Completion: 2022-07-22
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 302

Inclusion Criteria

1. Untreated, biopsy-proven adenocarcinoma of the prostate
2. Patient is being considered for curative-intent treatment with radical prostatectomy or radiotherapy
3. Patients must have high-risk features including at least one of the following features:
- PSA greater than or equal to 20.0 ng/ml within 12 weeks prior to randomisation
- Gleason group 3, 4 or 5
- Clinical stage greater than or equal to T3
4. Age greater than or equal to 18 years
5. Patient has provided written informed consent for participation in this trial
6. In the opinion of investigator, willing and able to comply with required study procedures

Exclusion Criteria

1. Participant has had any prior therapy for prostate cancer
2. Participant has undergone, within 8 weeks prior to randomisation, imaging for the primary purpose of staging nodal or distant metastatic disease of prostate cancer (MRI
performed for primary purpose of assessing T-stage or to guide biopsy is acceptable)
3. A history of other active malignancy within the last 5 years with exception of non-melanoma skin cancer or melanoma insitu
4. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
5. Significant intercurrent morbidity that, in the judgment of the investigator, would limit compliance with study protocols

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the diagnostic accuracy of PSMA-PET/CT to that of conventional imaging (CI) for detecting nodal or distant metastatic disease. <br>To define accuracy, diagnostic findings will be compared to the ground truth which will be established using all data available to the six-month follow-up time-point (+/-30 days). Cases will be considered positive by ground truth if they satisfy at least 1 hard criterion or at least 3 soft criteria amongst the pre-defined criteria listed in the protocol as evidence for one or more metastases. Where feasible, biopsy confirmation of disease is strongly encouraged. [The outcome will be assessable 6 months from randomisation]