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Diagnostic Test

PSMA PET/CT for Advanced Prostate Cancer (PATRON Trial)

Phase 3

Waitlist Available

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

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

High risk of regional or distant metastases as defined by any of: Newly diagnosed and untreated prostate cancer with CAPRA score 6-10, or stage cN1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

PATRON Trial Summary

This trial will study whether using PSMA PET/CT to guide treatment for high-risk prostate cancer results in better outcomes than using conventional imaging.

Who is the study for?

Men over 18 with high-risk prostate cancer who are planned for curative radiotherapy or surgery, or have had a prostatectomy and now show signs of cancer return. They should not have received other local treatments, be relatively fit (ECOG ≤ 2), and not on recent hormone therapy.Check my eligibility

What is being tested?

The trial is testing if using PSMA PET/CT scans to guide more intense treatment improves outcomes in advanced prostate cancer patients compared to standard imaging methods. Participants will either receive intensified therapy based on the scan results or follow conventional treatment protocols.See study design

What are the potential side effects?

Potential side effects may include typical risks associated with increased radiation exposure from intensified radiotherapy, surgical complications if procedures are escalated, and general risks linked to systemic therapies for those found with widespread disease.

PATRON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My prostate cancer is at high risk of spreading and either untreated or has a CAPRA score of 6-10.

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I had prostate surgery and my PSA levels are now above 0.1ng/mL.

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I have prostate cancer and am planning to undergo surgery or radiotherapy.

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I have been newly diagnosed with high-risk prostate cancer.

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I am 18 years old or older.

PATRON 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

To determine if PSMA PET/CT guided intensification of therapy is superior to standard of care (SOC) therapy as measured by improved failure-free survival (FFS).

Secondary outcome measures

Cost-effectiveness (EQ5D5L)

Impact of PMSA PET/CT on RT or surgical management (rate of treatment intensification)

New lesion detection yield (on PSMA PET/CT)

+3 more

PATRON Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental - PSMAiTxExperimental Treatment1 Intervention

Participants undergo PSMA PET/CT prior to treatment, and treated intensified based on image findings.

Group II: Control - SOC TreatmentActive Control1 Intervention

Participants to receive surgery or radiotherapy (+/- hormone therapy) as planned per SOC.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kingston Health Sciences CentreOTHER

31 Previous Clinical Trials

33,315 Total Patients Enrolled

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

128,837 Total Patients Enrolled

4 Trials studying Prostate Cancer

1,309 Patients Enrolled for Prostate Cancer

Canadian Cancer Society (CCS)OTHER

78 Previous Clinical Trials

36,945 Total Patients Enrolled

7 Trials studying Prostate Cancer

6,825 Patients Enrolled for Prostate Cancer

Media Library

PSMA PET/CT guided intensification of therapy (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04557501 — Phase 3

Prostate Cancer Research Study Groups: Control - SOC Treatment, Experimental - PSMAiTx

Prostate Cancer Clinical Trial 2023: PSMA PET/CT guided intensification of therapy Highlights & Side Effects. Trial Name: NCT04557501 — Phase 3

PSMA PET/CT guided intensification of therapy (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04557501 — Phase 3

Frequently Asked Questions

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

In how many locations is this study being conducted?

"This study is recruiting from a total of 11 locations, which are Royal Victoria Regional Health Centre in Barrie, Hopital de la Cité de la Santé in Laval, Princess Margaret Cancer Centre in Toronto, and 8 others."

Answered by AI

Does the FDA permit PSMA PET/CT to inform cancer treatment decisions?

"PSMA PET/CT guided intensification of therapy received a score of 3 on Power's safety scale. This is due to the fact that this is a Phase 3 trial, so while there is some supporting data, there are also multiple rounds of data supporting safety."

Answered by AI