PSMA-PET Registry for Recurrent Prostate Cancer (PREP)

March 16, 2023 updated by: Lawson Health Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

3070

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St. Joseph's Healthcare Hamilton
        • Contact:
        • Principal Investigator:
          • Bobby Shayegan, MD, FRCSC
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre
        • Contact:
          • Clinical Research Associate- Mena Gaed
          • Phone Number: 56601 519-685-8500
          • Email: mena.gaed@lhsc.on.ca
        • Sub-Investigator:
          • Glenn Bauman, MD, FRCPC
        • Principal Investigator:
          • Stephen Pautler, MD, FRCSC
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital, General Campus
        • Contact:
          • Clinical Research Assistant- David Yachnin
          • Phone Number: 74639 613-798-5555
          • Email: dyachnin@ohri.ca
        • Principal Investigator:
          • Luke Lavallee, MDCM, FRCSC
        • Sub-Investigator:
          • Eugene Leung, MD, FRCPC
        • Sub-Investigator:
          • Chris Morash, MD, FRCSC
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Recruiting
        • Thunder Bay Regional Health Sciences Centre
        • Contact:
          • Clinical Research Coordinator- Lori Moon, RN
          • Phone Number: 807-684-7226
          • Email: moonl@tbh.net
        • Principal Investigator:
          • Marlon Hagerty, MD
        • Sub-Investigator:
          • Walid Shahrour, MD, RCPSC
        • Sub-Investigator:
          • Jonathan Boekhoud, MD, FRCPC
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Toronto Sunnybrook Cancer Centre
        • Principal Investigator:
          • Laurence Klotz, MD, FRCSC
        • Sub-Investigator:
          • Robert Wolfson, MD
        • Contact:
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre, University Health Network
        • Principal Investigator:
          • Antonio Finelli, MD, FRCSC
        • Sub-Investigator:
          • Ur Metser, MD, FRCPC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
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)
Diagnostic test: [18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).
Experimental: Cohort 2
Men with biochemical failure after initial prostatectomy will be restaged with [18F]-DCFPyL PET/ CT scan (PSMA PET)
Diagnostic test: [18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).
Experimental: Cohort 3
Men with biochemical failure after initial radical prostatectomy and salvage radiotherapy will be restaged with [18F]-DCFPyL PET/ CT scan (PSMA PET)
Diagnostic test: [18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).
Experimental: Cohort 4
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)
Diagnostic test: [18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).
Experimental: Cohort 5
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)
Diagnostic test: [18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).
Experimental: Cohort 6
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)
Diagnostic test: [18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).
Experimental: Cohort 7
[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.
Diagnostic test: [18F]-DCFPyL PET/ CT scan (PSMA PET)
Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of disease detection on PSMA PET
Time Frame: 5 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine correlations between PSA levels at time of imaging and presence of disease detected on PSMA PET.
Time Frame: 5 years
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
Proportion of men with oligometastatic recurrence (four or fewer sites including the prostate bed if positive) confirmed on PSMA PET/CT
Time Frame: 5 years
Number of men with four or fewer sites of disease detected on PSMA PET
5 years
Number of men who have their management plan changed because of PSMA PET results
Time Frame: 5 years
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
To determine the actual management delivered within 6 months of PSMA PET
Time Frame: 5 years

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
5 years
Compare PSA response at 6 months against PSA at the time of PSMA PET
Time Frame: 5 years
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
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)
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Cancer Care Ontario
Centre for Probe Development and Commercialization

Investigators

  • Principal Investigator: Glenn Bauman, MD, FRCPC, Lawson Health Research Institute
  • Principal Investigator: Ur Metser, MD, FRCPC, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2018

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4826

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Prostate Cancer

Clinical Trials on [18F]-DCFPyL PET/ CT scan (PSMA PET)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe