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PSMA-PET Registry for Recurrent Prostate Cancer (PREP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03718260
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
Cancer Care Ontario
Centre for Probe Development and Commercialization
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Prostate Cancer Diagnostic Test: [18F]-DCFPyL PET/ CT scan (PSMA PET) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3070 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PSMA-PET Registry for Recurrent Prostate Cancer
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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).




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must be male (prostate cancer)
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718260


Contacts
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Contact: Catherine Hildebrand, PhD, Project Coordinator 519-685-8500 ext 53535 catherine.hildebrand@lhsc.on.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Research Coordinator- Camilla Tajzler    905-522-1155 ext 35876    tajzlec@mcmaster.ca   
Principal Investigator: Anil Kapoor, MD, FRCSC         
Sub-Investigator: Bobby Shayegan, MD, FRCSC         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Clinical Research Associate- Stephanie Horst    519-685-8500 ext 56601    stephanie.horst@lhsc.on.ca   
Principal Investigator: Joseph Chin, MD, FRCSC         
Sub-Investigator: Glenn Bauman, MD, FRCPC         
The Ottawa Hospital, General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Clinical Research Assistant- David Yachnin    613-798-5555 ext 74639    dyachnin@ohri.ca   
Principal Investigator: Luke Lavallee, MDCM, FRCSC         
Sub-Investigator: Eugene Leung, MD, FRCPC         
Sub-Investigator: Chris Morash, MD, FRCSC         
Thunder Bay Regional Health Sciences Centre Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Clinical Research Coordinator- Lori Moon, RN    807-684-7226    moonl@tbh.net   
Principal Investigator: Marlon Hagerty, MD         
Sub-Investigator: Walid Shahrour, MD, RCPSC         
Sub-Investigator: Jonathan Boekhoud, MD, FRCPC         
Toronto Sunnybrook Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Clinical Trial Coordinator- Marlene Kebabdjian    416-480-6100 ext 2890    Marlene.Kebabdjian@sunnybrook.ca   
Principal Investigator: Laurence Klotz, MD, FRCSC         
Sub-Investigator: Robert Wolfson, MD         
Princess Margaret Cancer Centre, University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Clinical Research Coordinator- Linda Chan    416-946-4501 ext 5734    Linda.Chan@uhn.ca   
Principal Investigator: Antonio Finelli, MD, FRCSC         
Sub-Investigator: Ur Metser, MD, FRCPC         
Sponsors and Collaborators
Lawson Health Research Institute
Cancer Care Ontario
Centre for Probe Development and Commercialization
Investigators
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Principal Investigator: Glenn Bauman, MD, FRCPC Lawson Health Research Institute
Principal Investigator: Ur Metser, MD, FRCPC University Health Network, Toronto
Additional Information:

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03718260    
Other Study ID Numbers: 4826
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawson Health Research Institute:
Prostate Cancer
Biochemical Failure
Node positive
PSMA-PET
[18F]DCFPyL PET/CT imaging
Radical Prostatectomy
Radiation Therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases