Back to results

PSMA-PET Registry for Recurrent Prostate Cancer (PREP)

Primary Purpose

Recurrent Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

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

About this trial

This is an interventional diagnostic trial for Recurrent Prostate Cancer focused on measuring Prostate Cancer, Biochemical Failure, Node positive, PSMA-PET, [18F]DCFPyL PET/CT imaging, Radical Prostatectomy, Radiation Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Phase 2

Inclusion Criteria:

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):
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
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).

Exclusion Criteria:

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.

Sites / Locations

St. Joseph's Healthcare HamiltonRecruiting
London Health Sciences CentreRecruiting
The Ottawa Hospital, General CampusRecruiting
Thunder Bay Regional Health Sciences CentreRecruiting
Toronto Sunnybrook Cancer CentreRecruiting
Princess Margaret Cancer Centre, University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Cohort 7

Arm Description

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)

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

Men with biochemical failure after initial radical prostatectomy and salvage radiotherapy will be restaged with [18F]-DCFPyL PET/ CT scan (PSMA PET)

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)

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)

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)

[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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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.

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

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.

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.

Full Information

NCT ID

NCT03718260

First Posted

October 17, 2018

Last Updated

March 16, 2023

Sponsor

Lawson Health Research Institute

Collaborators

Cancer Care Ontario, Centre for Probe Development and Commercialization

1. Study Identification

Unique Protocol Identification Number

NCT03718260

Brief Title

PSMA-PET Registry for Recurrent Prostate Cancer

Acronym

PREP

Official Title

PSMA-PET Registry for Recurrent Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 27, 2018 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lawson Health Research Institute

Collaborators

Cancer Care Ontario, Centre for Probe Development and Commercialization

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3070 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

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)

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Men with biochemical failure after initial radical prostatectomy and salvage radiotherapy will be restaged with [18F]-DCFPyL PET/ CT scan (PSMA PET)

Arm Title

Cohort 4

Arm Type

Experimental

Arm Description

Arm Title

Cohort 5

Arm Type

Experimental

Arm Description

Arm Title

Cohort 6

Arm Type

Experimental

Arm Description

Arm Title

Cohort 7

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Frequency of disease detection on PSMA PET

Description

Time Frame

5 years

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

5 years

Title

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

Description

Number of men with four or fewer sites of disease detected on PSMA PET

Time Frame

5 years

Title

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

Description

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.

Time Frame

5 years

Title

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

Description

Time Frame

5 years

Title

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

Description

Time Frame

5 years

Title

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)

Description

Time Frame

5 years

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Participants must be male (prostate cancer)

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Phase 2 Inclusion Criteria: 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). Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Catherine Hildebrand, PhD, Project Coordinator

Phone

519-685-8500

Ext

53535

catherine.hildebrand@lhsc.on.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glenn Bauman, MD, FRCPC

Organizational Affiliation

Lawson Health Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ur Metser, MD, FRCPC

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph's Healthcare Hamilton

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Research Coordinator- Teresa Balart

Phone

905-522-1155

Ext

37074

mbalart@stjosham.on.ca

First Name & Middle Initial & Last Name & Degree

Bobby Shayegan, MD, FRCSC

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Research Associate- Mena Gaed

Phone

519-685-8500

Ext

56601

mena.gaed@lhsc.on.ca

First Name & Middle Initial & Last Name & Degree

Stephen Pautler, MD, FRCSC

First Name & Middle Initial & Last Name & Degree

Glenn Bauman, MD, FRCPC

Facility Name

The Ottawa Hospital, General Campus

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Research Assistant- David Yachnin

Phone

613-798-5555

Ext

74639

dyachnin@ohri.ca

First Name & Middle Initial & Last Name & Degree

Luke Lavallee, MDCM, FRCSC

First Name & Middle Initial & Last Name & Degree

Eugene Leung, MD, FRCPC

First Name & Middle Initial & Last Name & Degree

Chris Morash, MD, FRCSC

Facility Name

Thunder Bay Regional Health Sciences Centre

City

Thunder Bay

State/Province

Ontario

ZIP/Postal Code

P7B 6V4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Research Coordinator- Lori Moon, RN

Phone

807-684-7226

moonl@tbh.net

First Name & Middle Initial & Last Name & Degree

Marlon Hagerty, MD

First Name & Middle Initial & Last Name & Degree

Walid Shahrour, MD, RCPSC

First Name & Middle Initial & Last Name & Degree

Jonathan Boekhoud, MD, FRCPC

Facility Name

Toronto Sunnybrook Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Coordinator- Marlene Kebabdjian

Phone

416-480-6100

Ext

2890

Marlene.kebabdjian@sunnybrook.ca

First Name & Middle Initial & Last Name & Degree

Laurence Klotz, MD, FRCSC

First Name & Middle Initial & Last Name & Degree

Robert Wolfson, MD

Facility Name

Princess Margaret Cancer Centre, University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Research Coordinator- Thamilne Ganesathasan

Thamiline.Ganesathasan@uhn.ca

First Name & Middle Initial & Last Name & Degree

Antonio Finelli, MD, FRCSC

First Name & Middle Initial & Last Name & Degree

Ur Metser, MD, FRCPC

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35608445

Citation

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.

Results Reference

derived

PubMed Identifier

35076300

Citation

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.

Results Reference

derived

Learn more about this trial

PSMA-PET Registry for Recurrent Prostate Cancer

We'll reach out to this number within 24 hrs