PSMA-PET Registry for Recurrent Prostate Cancer (PREP)

Lawson Health Research Institute

Status: Enrolling

Conditions: Recurrent Prostate Cancer

Treatments: Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Study type: Interventional

Funder types: Other

Identifiers

NCT03718260

4826

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,070 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,070 participants in 7 patient groups

Cohort 1

Experimental group

Description:

Men who are node positive or who have persistently detectable PSA after initial radical prostatectomy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Treatment:

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Cohort 2

Experimental group

Description:

Men with biochemical failure after initial prostatectomy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Treatment:

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Cohort 3

Experimental group

Description:

Men with biochemical failure after initial radical prostatectomy and salvage radiotherapy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Treatment:

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Cohort 4

Experimental group

Description:

Men with biochemical failure after initial radical prostatectomy with or without adjuvant/ salvage radiotherapy who are currently on salvage hormone therapy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Treatment:

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Cohort 5

Experimental group

Description:

Men who have prior PSMA directed treatment for oligometastatic disease, such as lesion directed therapy (e.g. stereotactic radiosurgery) or systemic therapy (e.g. hormone therapy or chemotherapy) with subsequent biochemical failure will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Treatment:

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Cohort 6

Experimental group

Description:

Men with biochemical failure after primary radiation therapy (external beam, brachytherapy or combinations together with or without hormone therapy) will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Treatment:

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)

Cohort 7

Experimental group

Description:

\[18F\]-DCFPyL as a problem-solving tool in patients with prostate cancer when confirmation of the site of disease and/or disease extent may impact clinical management. Patients in this cohort require approval from an independent adjudication by Cancer Care Ontario.

Treatment:

Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET)