PSMA-PET Registry for Recurrent Prostate Cancer Following Radical Prostatectomy

Official Title

PSMA-PET Registry for Recurrent Prostate Cancer Following Radical Prostatectomy

Summary:

This study aims to institute a province-wide registry leveraging the availability of a new Positron Emission Tomography tracer, [18F]-DCFPyL and PET expertise across Ontario centres to improve our ability to characterize patterns of recurrence and personalize therapies in men with recurrent prostate cancer after prostatectomy.

Trial Description

Primary Outcome:

  • Frequency of disease detection on PSMA PET
Secondary Outcome:
  • Proportion of men with lesions detectable on PSMA PET imaging but not conventional imaging (CT or bone scan)
  • Proportion of men with oligometastatic recurrence (four or fewer sites including the prostate bed if positive) confirmed on PSMA PET/CT
  • Proportion of men with extensive recurrence (more than four sites including the prostate bed if positive) confirmed on PSMA PET/CT
  • To determine rates of concordance in lesion detection between conventional imaging (CT/bone scan) and PSMA PET/CT
  • Proportion of men who have a change in usual management after PSMA PET
  • Proportion of men with detectable disease on PSMA PET/CT as a function of PSA parameters (absolute value, PSA velocity, PSA doubling time)
This registry study will provide Ontario centres access to a new Positron Emission Tomography (PET) tracer, [18F]-DCFPyL, to improve our ability to identify areas of prostate cancer recurrence in men who have undergone surgical removal of their prostate gland (radical prostatectomy) and there is a suspicion of recurrence of the cancer. Men with suspected persistent or recurrent disease can be identified on the basis of a rising Prostate Specific Antigen (PSA) blood test, or the presence of node positive disease at the time of their surgery, or a PSA blood test continues to be detectable within 3 months after their surgery. It is the aim of this study to determine if [18F]-DCFPyL PET/CT can potentially identify areas of prostate cancer recurrence not seen with usual imaging (bone scan/CT scans) and impact the management of the disease. As part of the patient eligibility for [18F]-DCFPyL PET/CT participating physicians will complete a planned management questionnaire prior to [18F]-DCFPyL PET/CT being acquired and after the [18F]-DCFPyL PET/CT information is provided. A report of the results of the [18F]-DCFPyL PET/CT will be provided to the participating physicians to determine a treatment plan. Actual interventions following completion of the [18F]-DCFPyL PET/CT will be tracked by linkage to provincial registries. Six centres across Ontario will participate in the registry study which is expected to take 4 years to complete with an additional one year of follow-up to capture patient outcomes.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society