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Radioligand Therapy

Radioligand + Radiation Therapy for Prostate Cancer

Phase 1

Recruiting

Led By David M Schuster, MD, FACR

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Adenocarcinoma of the prostate, post radical prostatectomy with detectable prostate specific antigen (PSA)

Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2

Must not have

Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy or prior RLT)

Risk factors for Lu-rhPSMA radioligand therapy (Baseline >= grade 2 myelosuppression, renal insufficiency [glomerular filtration rate (GFR) < 60 mL/min], or xerostomia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the safety and effectiveness of a radioactive drug combined with radiation therapy to treat prostate cancer that has returned after surgery.

Who is the study for?

Men over 18 with prostate cancer that has returned after surgery, who have detectable PSA levels and only show signs of cancer in the pelvic area on PSMA PET/CT scans. They should be relatively fit (ECOG status 0-2) and not have had prior radiotherapy or conditions like inflammatory bowel disease, severe kidney issues, high-risk urinary retention, significant liver damage, low blood counts, or serious acute illnesses.

What is being tested?

This phase I trial is testing a new radioactive drug called lutetium Lu 177 PSMA-10.1 after external beam radiation therapy guided by PSMA PET scans. The goal is to find the safest dose that can effectively target tumor cells without harming normal ones in patients whose prostate cancer has come back post-surgery.

What are the potential side effects?

Possible side effects include myelosuppression (reduced bone marrow activity), renal insufficiency (poor kidney function), xerostomia (dry mouth), gastrointestinal toxicity, as well as typical risks associated with radiation such as fatigue and skin reactions.

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 my PSA levels are now detectable.

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I can take care of myself and am up and about more than half of the day.

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I am over 18 years old.

Exclusion Criteria

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

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I cannot have radiotherapy due to certain health conditions or previous treatments.

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I do not have severe bone marrow suppression, kidney issues with a GFR under 60, or chronic dry mouth.

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I have severe urinary blockage or kidney swelling.

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My kidney function is reduced, with a GFR under 60 or creatinine over 1.5 times the normal limit.

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I do not have severe blood, kidney, liver, mouth dryness, or stomach side effects.

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I do not have severe health issues like recent heart failure, serious infections, or severe lung problems.

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

Incidence of radiotherapy and radioligand therapy related adverse events

Secondary study objectives

Circulating tumor deoxyribonucleic acid (ctDNA) differences

Tumor and organ at risk dosimetry

ctDNA differences

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (EBRT, 177Lu-rhPSMA-10.1)Experimental Treatment7 Interventions

Patients undergo EBRT followed by 177Lu-rhPSMA-10.1 IV on study. Patients also receive rhPSMA-7.3 IV with PET/CT at screening and undergo SPECT-CT and collection of blood samples on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Positron Emission Tomography

2011

Completed Phase 2

~2200