NCT03718260

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,070

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

5.4 years

First QC Date

October 17, 2018

Last Update Submit

March 16, 2023

Conditions

Recurrent Prostate Cancer

Keywords

Prostate CancerBiochemical FailureNode positivePSMA-PET[18F]DCFPyL PET/CT imagingRadical ProstatectomyRadiation Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

    5 years

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

    5 years

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

    5 years

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

    5 years

  • Compare PSA response at 6 months against PSA at the time of PSMA PET

    5 years

  • +1 more secondary outcomes

Study Arms (7)

Cohort 1

EXPERIMENTAL

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)

Cohort 2

EXPERIMENTAL

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)

Cohort 3

EXPERIMENTAL

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)

Cohort 4

EXPERIMENTAL

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)

Cohort 5

EXPERIMENTAL

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)

Cohort 6

EXPERIMENTAL

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)

Cohort 7

EXPERIMENTAL

\[18F\]-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)

Interventions

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

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

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6Cohort 7

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be male (prostate cancer)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent obtained
  • Male, Age ≥ 18 years
  • 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.
  • Suspected persistent or recurrent disease defined as one of the following (unless PET/CT requested as part of Cohort 7):
  • 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
  • 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
  • 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.
  • Karnofsky performance status 70 or better (ECOG 0, 1).
  • 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).

You may not qualify if:

  • Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components.
  • Prior PSMA PET scan within 6 months of enrollment.
  • Patient cannot lie still for at least 60 minutes or comply with imaging.
  • Patients falling outside of Cohorts 1-6 where independent adjudication by CCO does not support participation in the Registry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

RECRUITING

Toronto Sunnybrook Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre, University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Related Publications (2)

  • Basso Dias A, Finelli A, Bauman G, Veit-Haibach P, Berlin A, Ortega C, Avery L, Metser U. Impact of 18F-DCFPyL PET on Staging and Treatment of Unfavorable Intermediate or High-Risk Prostate Cancer. Radiology. 2022 Sep;304(3):600-608. doi: 10.1148/radiol.211836. Epub 2022 May 24.

    PMID: 35608445DERIVED

  • Metser U, Zukotynski K, Mak V, Langer D, MacCrostie P, Finelli A, Kapoor A, Chin J, Lavallee L, Klotz LH, Hagerty M, Hildebrand C, Bauman G. Effect of 18F-DCFPyL PET/CT on the Management of Patients with Recurrent Prostate Cancer: Results of a Prospective Multicenter Registry Trial. Radiology. 2022 May;303(2):414-422. doi: 10.1148/radiol.211824. Epub 2022 Jan 25.

    PMID: 35076300DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Glenn Bauman, MD, FRCPC

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR

  • Ur Metser, MD, FRCPC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Hildebrand, PhD, Project Coordinator

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 24, 2018

Study Start

September 27, 2018

Primary Completion

March 1, 2024

Study Completion

December 1, 2025

Last Updated

March 17, 2023

Record last verified: 2023-03

Locations

CA(6)