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Radioisotope Therapy

Treatment (177Lu-PSMA-617) for Prostate Cancer

Phase 2
Waitlist Available
Led By Amir Iravani, MD FRACP
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patients must have the ability to understand and sign an approved informed consent.
* Patients must have the ability to understand and comply with all protocol requirements.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This phase II trial tests how well 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that remains despite treatment (resistant). Lutetium Lu 177 (177Lu), the radioactive (tracer) component being delivered by prostate-specific membrane antigen (PSMA)-617, has physical properties that make it ideal radionuclide (imaging tests that uses a small dose tracer) for treatment of metastatic castrate-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 works by binding to prostate cancer cells and inducing damage to deoxyribonucleic acid (DNA) inside prostate cancer cells. Giving 177Lu-PSMA-617 may improve treatment outcomes for patients with mCRPC.

Who is the study for?
This trial is for patients with prostate cancer that has spread and is resistant to treatment. Participants must have a specific low level of PSMA expression, which will be determined by scans.
What is being tested?
The study tests the effectiveness of an intensified dose of 177Lu-PSMA-617 in treating metastatic castrate-resistant prostate cancer (mCRPC). It involves various imaging techniques like bone scans, CTs, PET-CTs, SPECT, MRI, and biospecimen collection.
What are the potential side effects?
Potential side effects may include radiation exposure risks from the tracer used in imaging and treatment-related reactions such as nausea or fatigue. Specific side effects related to DNA damage within cancer cells are also possible.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Prostate-specific antigen (PSA) progression-free survival (PFS)
Secondary study objectives
Duration of response (DOR)
Health-related quality of life: Eastern Cooperative Oncology Group (ECOG) Performance Status scale
Health-related quality of life: Functional Assessment of Cancer Therapy Prostate (FACT-P)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (177Lu-PSMA-617)Experimental Treatment8 Interventions
Patients receive 177Lu-PSMA-617 IV over 30 minutes on days 1, 8, 50, 57, 99 and 141. Treatment repeats every 7 days for cycles 1 and 3 and every 6 weeks for cycle 2 and subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PSMA-PET/CT during screening and SPECT/CT on study. Patients also undergo CT or MRI, bone scan, as well as blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Scan
2015
Completed Phase 2
~50
Computed Tomography
2017
Completed Phase 2
~2720
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310
Biospecimen Collection
2004
Completed Phase 2
~1720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,778 Previous Clinical Trials
1,896,068 Total Patients Enrolled
18 Trials studying Prostate Cancer
8,244 Patients Enrolled for Prostate Cancer
Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mars Shot Research FundUNKNOWN
NovartisIndustry Sponsor
1,621 Previous Clinical Trials
2,722,041 Total Patients Enrolled
22 Trials studying Prostate Cancer
4,934 Patients Enrolled for Prostate Cancer
~34 spots leftby Dec 2027
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