PSMA-PET Registry for Recurrent Prostate Cancer

Recurrent Prostate Cancer Clinical Trial

— PREP  

Official title:

PSMA-PET Registry for Recurrent Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03718260
• Other study ID #: 4826
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Lawson Health Research Institute
• Contact: Catherine Hildebrand, PhD, Project Coordinator
• Phone: 519-685-8500
• Email: catherine.hildebrand[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3070
• Est. completion date: December 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Recurrence
• Recurrent Prostate Cancer

Intervention

Diagnostic Test:
• [18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	The Ottawa Hospital, General Campus	Ottawa	Ontario
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Princess Margaret Cancer Centre, University Health Network	Toronto	Ontario
Canada	Toronto Sunnybrook Cancer Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Cancer Care Ontario, Centre for Probe Development and Commercialization

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years
Secondary	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.	5 years
Secondary	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	5 years
Secondary	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.	5 years
Secondary	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: Delivery of radiotherapy (anatomic site, dose and fractionation) - Cancer Care Ontario; Biopsy of suspected recurrences (anatomic site, histology) - Provincial pathology database; Use of salvage lymph node dissections - CIHI; Use of salvage hormonal therapy/androgen deprivation	5 years
Secondary	Compare PSA response at 6 months against PSA at the time of PSMA PET	PSA response will be examined by comparing 6 month PSA against PSA at the time of PSMA PET through the Ontario Laboratory Information Services and correlated with actual management as determined in Outcome 5.	5 years
Secondary	Compare the detection rates of PSMA PET/CT when conventional imaging is used as part of the eligibility criteria (PREP) versus when conventional imaging is omitted (PREP Phase 2)	Number of men with detectable lesions as determined in the primary objective for PREP will be compared to the number of men with detectable lesions as determined in primary objective for PREP Phase 2.	5 years