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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

No Placebo-Only Group

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.

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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:

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I cannot stay still for 60 minutes for a scan.

Select...

My prostate cancer has specific aggressive features.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 6Eligibility criteria met