PSMA-PET Registry for Recurrent Prostate Cancer

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's3,070 enrolled

Overview

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 centers to improve our ability to characterize patterns of recurrence and personalize therapies in men with recurrent prostate cancer after primary treatment.

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) or radiation of their prostate (external beam radiation, brachytherapy or a combination of both) 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. A report of the results of the \[18F\]-DCFPyL PET/CT will be provided to the participating physicians to determine a treatment plan. As part of the patient eligibility for \[18F\]-DCFPyL PET/CT participating physicians will complete a questionnaire after the \[18F\]-DCFPyL PET/CT information is provided to report how the results impact patient management. 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. PREP Phase 2 was initiated to investigate the hypothesis that conventional imaging is not adding to the information provided by PSMA PET/CT alone. PREP Phase 2 will retain the same study design as Phase I but will remove bone scan and computed tomography as criteria for entry into the study except for those patients with higher PSA (\>10 ng/ml). Identical cohort sizes will be accrued in Phase 2 to permit comparison of detection rates with similar confidence intervals with and without conventional imaging. Transition to PREP Phase 2 occurred when overall accrual to PREP exceeded 80% of target.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

3,070

Conditions

Recurrent Prostate Cancer

Interventions

[18F]-DCFPyL PET/ CT scan (PSMA PET)DIAGNOSTIC_TEST

Participants will undergo re-staging with \[18F\]-DCFPyL PET/CT Scan (PSMA PET).

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Phase 2 Inclusion Criteria: 1. Written informed consent obtained 2. Male, Age ≥ 18 years 3. Prior primary treatment for prostate cancer with curative intent such as radical prostatectomy or radiotherapy for localized prostate cancer. Unless PET/CT requested as part of Cohort 7. 4. Suspected persistent or recurrent disease defined as one of the following (unless PET/CT requested as part of Cohort 7): 1. High risk disease at the time of radical prostatectomy characterized by pathologically involved node(s) or persistently detectable PSA (\>0.1ng/ml) within 3 months post-surgery 2. Primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following: i. Following primary radical prostatectomy, BF is defined as rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured at \>0.1 ng/ml ii. Following primary radiotherapy for localized disease, BF is defined according to the Phoenix Definition, which is rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured greater than the nadir PSA + 2.0 ng/ml 5. Patient scenario falls into one of the 7 pre-defined cohorts. When patient scenario falls outside cohorts 1-6 participation in the Registry must be approved through the established CCO adjudication process for Cohort 7. 6. Karnofsky performance status 70 or better (ECOG 0, 1). 7. If PSA \>10 mg/mL, conventional imaging consisting of bone scan and abdo-pelvic CT scan within 3 months of registration that is either equivocal, negative (no lesions) or positive for oligometastatic disease (4 or fewer unequivocal lesions identified). Exclusion Criteria: 1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components. 2. Prior PSMA PET scan within 6 months of enrollment. 3. Patient cannot lie still for at least 60 minutes or comply with imaging. 4. Patients falling outside of Cohorts 1-6 where independent adjudication by CCO does not support participation in the Registry.

Locations (6)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

Frequency of disease detection on PSMA PET

Phase 1: The number of men with detectable lesions on PSMA PET who have suspected recurrent or persistent disease post radical prostatectomy with or without adjuvant or salvage pelvic radiotherapy or hormone therapy as well as men treated with primary radiotherapy will be measured Phase 2: The number of men with detectable lesions on PSMA PET who have suspected recurrent or persistent disease post radical prostatectomy with or without adjuvant or salvage pelvic radiotherapy or hormone therapy as well as men treated with primary radiotherapy will be measured when PSMA PET/CT is used without routine pre-screening with conventional imaging.

Time frame: 5 years

Secondary Outcomes

To determine correlations between PSA levels at time of imaging and presence of disease detected on PSMA PET.

The likelihood of disease detected on PSMA PET will be correlated with absolute PSA level at the time of PSMA PET as supplied on the eligibility form.

Time frame: 5 years

Proportion of men with oligometastatic recurrence (four or fewer sites including the prostate bed if positive) confirmed on PSMA PET/CT

Number of men with four or fewer sites of disease detected on PSMA PET

Time frame: 5 years

Number of men who have their management plan changed because of PSMA PET results

The number of men who have a change in management as indicated by responses from referring physicians on an impact questionnaire completed after PSMA PET scans are reported.

Time frame: 5 years

To determine the actual management delivered within 6 months of PSMA PET

Actual management within 6 months will be determined through linkage to existing health information registries and will include: 1. Delivery of radiotherapy (anatomic site, dose and fractionation) - Cancer Care Ontario 2. Biopsy of suspected recurrences (anatomic site, histology) - Provincial pathology database 3. Use of salvage lymph node dissections - CIHI 4. Use of salvage hormonal therapy/androgen deprivation

Central Contacts

Catherine Hildebrand, PhD, Project Coordinator

CONTACT

519-685-8500 catherine.hildebrand@lhsc.on.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.