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Radiopharmaceutical

PSMA-11 PET/CT Imaging for Recurrent Prostate Cancer (PSMA SRT Trial)

Phase 3

Waitlist Available

Led By Jeremie Calais

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histopathology proven prostate cancer

Planned SRT for recurrence after primary prostatectomy

Must not have

Contraindications to radiotherapy (including active inflammatory bowel disease)

Extra-pelvic metastasis on any imaging or biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new way to find and diagnose prostate cancer that has come back after surgery, using a solution that is taken up by cancer cells. The hope is that this will help doctors plan better for salvage radiation therapy in participants with recurrent prostate cancer.

Who is the study for?

This trial is for men with prostate cancer recurrence post-surgery, who are willing to undergo radiotherapy. They must have a PSA level of at least 0.1 ng/ml and agree that their treatment plan may include findings from the PET/CT scan. Men currently on hormone therapy or with inflammatory bowel disease, extra-pelvic metastasis, or using other investigational drugs can't participate.

What is being tested?

The study tests if a diagnostic procedure using Gallium Ga 68-labeled PSMA-11 (a substance taken up by cancer cells) combined with PET/CT scans can help in planning salvage radiation therapy for recurrent prostate cancer after surgery.

What are the potential side effects?

While this trial focuses on diagnosis rather than treatment, potential side effects could relate to the imaging process such as allergic reactions to tracers or discomfort from lying still during the PET/CT scan.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer diagnosis was confirmed through tissue examination.

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I am scheduled for radiation therapy after prostate surgery due to cancer recurrence.

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I am willing to undergo radiotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo radiotherapy due to certain health conditions like active inflammatory bowel disease.

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My cancer has spread beyond the pelvic area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Success rate of salvage radiation therapy (SRT)

Secondary study objectives

Biochemical progression-free survival rate

Change in initial treatment intent

Initiation of additional salvage therapy after completion of SRT

+1 more

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (68Ga-PSMA-11 PET/CT)Experimental Treatment3 Interventions

Participants receive 68Ga-PSMA-11 IV and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist.

Group II: Arm I (standard of care)Active Control1 Intervention

Participants receive standard of care SRT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gallium Ga 68-labeled PSMA-11

2019

Completed Phase 2

~1030

Computed Tomography

2017