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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

PREP Trial 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.Check my eligibility

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.See study design

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.

PREP Trial 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.

PREP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of disease detection on PSMA PET

Secondary outcome measures

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

PREP 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 / 4Eligibility criteria met

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

658 Previous Clinical Trials

410,588 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any U.S.-based facilities administering this research?

"The following 6 sites are currently enrolled in this trial: Thunder Bay Regional Health Sciences Centre, St. Joseph's Healthcare Hamilton, Toronto Sunnybrook Cancer Centre and 3 other medical centres."

Answered by AI

Are there any open slots for participants in this experiment?

"Affirmative. According to the information available on clinicaltrials.gov, this scientific experiment is presently searching for participants with recruitment beginning on September 27th 2018 and last updated December 14th 2021. The trial seeks a total of 3070 patients across 6 different locations."

Answered by AI

How many people are involved in this clinical experiment?

"Affirmative. According to the information recorded on clinicaltrials.gov, this trial has been actively recruiting since it was launched on September 27th 2018 and recently updated in December 14th 2021. The study is searching for 3070 individuals from 6 different sites."

Answered by AI

Recent research and studies

RadiologyJournal

Effect of <sup>18</sup>f-dcfpyl PET/CT on the Management of Patients with Recurrent Prostate Cancer: Results of a Prospective Multicenter Registry Trial

Metser, Ur, Katherine Zukotynski, Victor Mak, Deanna Langer, Pamela MacCrostie, Antonio Finelli, Anil Kapoor, et al.. 2022. “Effect of 18f-dcfpyl PET/CT on the Management of Patients with Recurrent Prostate Cancer: Results of a Prospective Multicenter Registry Trial”. Radiology. Radiological Society of North America (RSNA). doi:10.1148/radiol.211824.

RadiologyJournal

Impact of <sup>18</sup>f-dcfpyl PET on Staging and Treatment of Unfavorable Intermediate or High-risk Prostate Cancer

Basso Dias, Adriano, Antonio Finelli, Glenn Bauman, Patrick Veit-Haibach, Alejandro Berlin, Claudia Ortega, Lisa Avery, and Ur Metser. 2022. “Impact of 18f-dcfpyl PET on Staging and Treatment of Unfavorable Intermediate or High-risk Prostate Cancer”. Radiology. Radiological Society of North America (RSNA). doi:10.1148/radiol.211836.

clinicaltrials.govStudy

PSMA-PET Registry for Recurrent Prostate Cancer

2018. "PSMA-PET Registry for Recurrent Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03718260.

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