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PSMA-PET Scan for Recurrent Prostate Cancer (PREP Trial)

N/A
Recruiting
Led By Glenn Bauman, MD, FRCPC
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Male, Age ≥ 18 years
Must not have
Patient cannot lie still for at least 60 minutes or comply with imaging.
Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial will use a new PET tracer to study how prostate cancer recurs and to develop personalized therapies.

Who is the study for?
Men over 18 who've had primary treatment for prostate cancer and suspect it's come back. They must have a rising PSA level after surgery or radiotherapy, be able to lie still for an hour, and not have had a PSMA PET scan in the last 6 months. Those with certain aggressive cancer types or who don't fit specific study groups without approval are excluded.
What is being tested?
The trial is testing a new type of PET scan using [18F]-DCFPyL to detect recurrent prostate cancer across Ontario. It aims to personalize therapy by better understanding how the cancer comes back after initial treatment.
What are the potential side effects?
There may be minimal side effects from the [18F]-DCFPyL PET/CT scan, typically related to lying still for the procedure or reactions at the injection site; however, significant adverse effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had surgery for prostate cancer and still have signs of the disease.
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I am a man aged 18 or older.
Select...
I have prostate cancer and my PSA levels are rising after initial treatment.
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I can care for myself and am able to carry out normal activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot stay still for 60 minutes for a scan.
Select...
My prostate cancer has specific aggressive features.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of disease detection on PSMA PET
Secondary study objectives
Compare PSA response at 6 months against PSA at the time of PSMA PET
PET/CT scan
Number of men who have their management plan changed because of PSMA PET results
+3 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort 7Experimental Treatment1 Intervention
\[18F\]-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.
Group II: Cohort 6Experimental Treatment1 Intervention
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)
Group III: Cohort 5Experimental Treatment1 Intervention
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)
Group IV: Cohort 4Experimental Treatment1 Intervention
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)
Group V: Cohort 3Experimental Treatment1 Intervention
Men with biochemical failure after initial radical prostatectomy and salvage radiotherapy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)
Group VI: Cohort 2Experimental Treatment1 Intervention
Men with biochemical failure after initial prostatectomy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)
Group VII: Cohort 1Experimental Treatment1 Intervention
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)

Find a Location

Who is running the clinical trial?

Centre for Probe Development and CommercializationOTHER
6 Previous Clinical Trials
243 Total Patients Enrolled
1 Trials studying Prostate Cancer
45 Patients Enrolled for Prostate Cancer
Lawson Health Research InstituteLead Sponsor
672 Previous Clinical Trials
411,441 Total Patients Enrolled
16 Trials studying Prostate Cancer
645 Patients Enrolled for Prostate Cancer
Cancer Care OntarioOTHER
16 Previous Clinical Trials
88,963 Total Patients Enrolled

Media Library

[18F]-DCFPyL PET/ CT scan (PSMA PET) Clinical Trial Eligibility Overview. Trial Name: NCT03718260 — N/A
Prostate Cancer Research Study Groups: Cohort 5, Cohort 7, Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 6
Prostate Cancer Clinical Trial 2023: [18F]-DCFPyL PET/ CT scan (PSMA PET) Highlights & Side Effects. Trial Name: NCT03718260 — N/A
[18F]-DCFPyL PET/ CT scan (PSMA PET) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03718260 — N/A
~444 spots leftby Sep 2025
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