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PSMA-PET Imaging for Prostate Cancer

Phase 3
Recruiting
Led By Daniel Juneau, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is investigating whether a new imaging technique, PSMA-PET, can help guide treatment and find predictive imaging biomarkers through deep learning techniques in men with prostate cancer.

Who is the study for?
This trial is for men with prostate cancer who are being treated at CHUM and have been recommended by their doctor to get a PSMA-PET scan. It's not suitable for those who can't undergo imaging procedures due to claustrophobia or other reasons.
What is being tested?
The study tests the use of a new PET probe called [18F]DCFPyL IV injection in detecting metastases in prostate cancer patients. It aims to combine this advanced imaging technique with deep learning to find predictive biomarkers.
What are the potential side effects?
As the intervention involves an imaging procedure, potential side effects may include discomfort from lying still during the scan and reactions to the tracer like mild rash or nausea, though serious side effects are rare.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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
Overall survival
Secondary study objectives
Progression free survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Main armExperimental Treatment1 Intervention
PET-CT imaging following 18F-DCFPyL injection, 1 injection, IV, 10 mCi

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
378 Previous Clinical Trials
130,551 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,109 Patients Enrolled for Prostate Cancer
Daniel Juneau, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
2 Previous Clinical Trials
20,500 Total Patients Enrolled

Media Library

18F-DCFPyL IV injection Clinical Trial Eligibility Overview. Trial Name: NCT03594760 — Phase 3
Prostate Cancer Research Study Groups: Main arm
Prostate Cancer Clinical Trial 2023: 18F-DCFPyL IV injection Highlights & Side Effects. Trial Name: NCT03594760 — Phase 3
18F-DCFPyL IV injection 2023 Treatment Timeline for Medical Study. Trial Name: NCT03594760 — Phase 3
~392 spots leftby Dec 2028
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