PSMA-PET Registry for Recurrent Prostate Cancer

NCT03718260 | Completed

• 1 other identifier: 4826
• Study Type: interventional
• Target: 9,684
• Locations: 1 country
• Sites: 7

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.

Conditions

Recurrent Prostate Cancer

Keywords

Prostate Cancer; Biochemical Failure; Node positive; PSMA-PET; [18F]DCFPyL and [18F]-PSMA 1007 PET/CT imaging; Radical Prostatectomy; Radiation Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• To determine the proportion of men who have "actionable disease" identified on PSMA PET with [18F]-DCFPyL or [18F]PSMA-1007.

  Phase 3: Actionable disease is defined as PET identified lesions where targeted therapy with radiation, surgery or other focal, PET lesion directed intervention (i.e. biopsy) is possible (men with oligometastatic and/or locoregional disease only).

  5 years

Secondary Outcomes (13)

• Determine correlations between PSA levels at time of study enrollment 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

Study Arms (9)

Cohort 1

EXPERIMENTAL

Men who are node positive or who have persistently detectable PSA after initial radical prostatectomy will be restaged with \[18F\]-DCFPyL or \[18F\]PSMA-1007 PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL or [18F]PSMA-1007 PET/ CT scan (PSMA PET)

Cohort 2

EXPERIMENTAL

Men with biochemical failure after initial prostatectomy will be restaged with \[18F\]-DCFPyL or \[18F\]PSMA-1007 PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL or [18F]PSMA-1007 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 or \[18F\]PSMA-1007 PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL or [18F]PSMA-1007 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 or \[18F\]PSMA-1007 PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL or [18F]PSMA-1007 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 or \[18F\]PSMA-1007 PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL or [18F]PSMA-1007 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 or \[18F\]PSMA-1007 PET/ CT scan (PSMA PET)

Diagnostic Test: [18F]-DCFPyL or [18F]PSMA-1007 PET/ CT scan (PSMA PET)

Cohort 7

EXPERIMENTAL

\[18F\]-DCFPyL or \[18F\]PSMA-1007 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 or [18F]PSMA-1007 PET/ CT scan (PSMA PET)

Cohort 0

EXPERIMENTAL

Initial staging with \[18F\]-DCFPyL or \[18F\]PSMA-1007 PET/ CT scan (PSMA PET) for high risk men being evaluated for primary therapy with surgery or radiation. Men with adverse clinical staging features (cT3, PSA \>20, Gleason Grade Group 4-5) have a higher risk of extra-prostatic spread and rates of clinical failure with prostate only directed treatment (surgery or radiation).

Diagnostic Test: [18F]-DCFPyL or [18F]PSMA-1007 PET/ CT scan (PSMA PET)

Cohort 8

EXPERIMENTAL

Men with castrate resistant prostate cancer with progression after at least one line of second line hormone therapy or taxane therapy. PSMA targeting PET/CT will be used to assess if men accrued would meet the imaging biomarker eligibility criteria for RLT as published by Sartor (Sartor, 2021).

Diagnostic Test: [18F]-DCFPyL or [18F]PSMA-1007 PET/ CT scan (PSMA PET)

Interventions

[18F]-DCFPyL or [18F]PSMA-1007 PET/ CT scan (PSMA PET) DIAGNOSTIC_TEST

Participants will undergo re-staging with \[18F\]-DCFPyL or \[18F\]PSMA-1007 PET/CT Scan (PSMA PET).

Cohort 0; Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be male (prostate cancer)
• Healthy Volunteers: No
• Age Groups: Adult (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.
• Phase 3
• Written informed consent obtained
• Male, Age ≥ 18 years
• Biopsy proven, clinically high risk (cT3, PSA ≥20, biopsy Gleason Grade Group 4-5) prostate cancer undergoing initial staging prior to primary treatment with surgery or radiotherapy
• Biochemical failure (BF) with current management defined as at least two consecutive rises in PSA measured at least 1 month apart with the most recent PSA level \>0.1 ng/ml (post radical prostatectomy or post PSMA Directed therapy, Cohorts 1-5) or PSA level \> nadir PSA + 2.0 ng/ml (Phoenix definition post radiotherapy failure, Cohorts 5, 6)
• Men with rising PSA and/or progression on conventional imaging despite prior second line hormone therapy or chemotherapy for castrate resistant prostate cancer (Cohort 8).
• PET/CT requested as part of Cohort 7.
• Patient scenario falls into one of the 8 pre-defined cohorts. When patient scenario falls outside cohorts 0-6 and 8, 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 recurrent disease suspected and PSA prior to PSMA PET/CT is \>10 ng/ml, conventional imaging consisting of bone scan and abdominal-pelvic CT scan performed within 3 months of registration that is either equivocal, negative (no lesions) or positive for oligometastatic disease (4 or fewer unequivocal lesions identified). Registration is defined as Form A: Eligibility is complete.
• If patient is enrolled in Cohort 8, conventional imaging consisting of at least bone scan and abdominal-pelvic CT scan completed within 3 months of registration. Registration is defined as Form A: Eligibility is complete.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Cancer Care Ontario: collaborator
• Centre for Probe Development and Commercialization: collaborator

Study Sites (7)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Toronto Sunnybrook Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre, University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Windsor Regional Hospital

Windsor, Ontario, Canada

Location

Related Publications (3)

• Kohan A, Metser U, Luke W, Rashid M, Langer DL, MacCrostie P, Green B, Mak V, Kulkarni GS, Finelli A, Shayegan B, Pautler SE, Klotz L, Hagerty M, Lavallee LT, Hildebrand C, Bauman G. A Prospective Provincial Registry of 18F-PSMA PET/CT for Recurrent Prostate Cancer: Results for 4,135 Men. J Nucl Med. 2025 Aug 1;66(8):1223-1231. doi: 10.2967/jnumed.125.269653.

  PMID: 40610233 DERIVED

• 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: 35608445 DERIVED

• 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: 35076300 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

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

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: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: July 17, 2026

Record last verified: 2025-09

Locations

CA (7)