← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I had surgery for prostate cancer and my PSA levels are now detectable.

Select...

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

Select...

I am over 18 years old.

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

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

Primary outcome measures

Incidence of radiotherapy and radioligand therapy related adverse events

Secondary outcome measures

Circulating tumor deoxyribonucleic acid (ctDNA) differences

Tumor and organ at risk dosimetry

ctDNA differences

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

Biospecimen Collection

2004

Completed Phase 2

~1700

External Beam Radiation Therapy

2006

Completed Phase 3

~3070

Computed Tomography

2017

Completed Phase 2

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

Single Photon Emission Computed Tomography

2008

Completed Phase 4

~310

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,686 Total Patients Enrolled

17 Trials studying Prostate Cancer

7,157 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,671 Previous Clinical Trials

40,926,759 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

David M Schuster, MD, FACRPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Frequently Asked Questions

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

To what degree are patients safeguarded when using EBRT and 177Lu-rhPSMA-10.1 together?

"We at Power rate Treatment (EBRT, 177Lu-rhPSMA-10.1) with a score of 1 because this is an early phase trial; there are only sparse data points to support its safety and efficacy."

Answered by AI

Is the enrollment process for this clinical trial still open?

"The clinical trial in question is not currently on the search for participants, as evidenced by its entry on clinicaltrials.gov which was last edited October 25th 2023. Fortunately, there are two thousand other active medical trials available right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer

David M Schuster 2023. "Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06105918.

All > Recurrent Prostate Cancer