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Radioisotope Therapy

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 a positive 68Ga-PSMA PET/CT scan with no PSMA negative lesion

Patients must have received at least one androgen receptor pathway inhibitor (ARPI)

Must not have

Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy

Patients with a history of central nervous system (CNS) metastases must have received therapy and be neurologically stable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new treatment called 177Lu-PSMA-617 for patients with prostate cancer that has spread to other parts of the body and has not responded to treatment. The treatment works

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

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My PET/CT scan shows cancer that is PSMA positive without any PSMA negative spots.

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I have been treated with medication that targets the androgen receptor.

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I have been treated with 1 or 2 taxane-based therapies before.

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My hepatitis B virus load is undetectable with treatment.

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I am 18 years old or older.

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I am able to care for myself and can move around.

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My prostate cancer diagnosis was confirmed through lab tests.

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I have undergone orchiectomy or am on androgen-deprivation therapy with low testosterone levels.

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My prostate cancer is worsening despite treatment.

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My kidney function is within the normal range.

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I had hepatitis C but have been successfully treated and cured.

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My liver enzymes are within the required limits.

Exclusion Criteria

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

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I am not currently receiving any other cancer treatments like chemotherapy or immunotherapy.

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I have had brain metastases, received treatment, and am now stable.

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I haven't had certain radiation treatments in the last 6 months.

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I am experiencing symptoms or have been diagnosed with spinal cord compression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

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 (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

Biospecimen Collection

2004

Completed Phase 3

~2030

Single Photon Emission Computed Tomography

2008

Completed Phase 4

~320