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Radiopharmaceutical

Flexible Dosing of 177Lu-PSMA-617 for Advanced Prostate Cancer

Phase 2

Recruiting

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

Patients must have received at least one androgen-receptor signaling inhibitors (ARSI)

Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Must not have

Less than 6 weeks since last myelosuppressive therapy (including docetaxel, cabazitaxel, strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, hemi-body irradiation)

Glomerular filtration rate (GFR) < 30 ml/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of the first cycle of lu 177 vipivotide tetraxetan (177lu-prostate-specific membrane antigen [psma]-617) therapy, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment schedule for patients with advanced prostate cancer that has spread to other parts of the body. The current standard treatment involves 6 cycles of a therapy called 177Lu-pro

Who is the study for?

This trial is for individuals with metastatic castration-resistant prostate cancer, which continues to grow despite low testosterone levels from traditional hormone therapy. Participants should have PSMA receptors on tumor cells and be suitable for a flexible treatment schedule.

What is being tested?

The study is testing a new dosing schedule of the drug 177Lu-PSMA-617 over 12 cycles versus the standard 6 cycles. It includes imaging techniques like PET scans and CTs to monitor progress, along with 'treatment holiday' periods.

What are the potential side effects?

Possible side effects include radiation-related symptoms such as fatigue, nausea, dry mouth or changes in taste due to lutetium's attachment to tumor cells and its radioactive properties.

Eligibility Criteria

Inclusion Criteria

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

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I have been treated with medication that targets hormone receptors.

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I am able to care for myself and up to being unable to work but can still move around.

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I am 18 years old or older.

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My prostate cancer diagnosis was confirmed through tissue examination.

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I have had chemotherapy for metastatic castration-resistant prostate cancer.

Exclusion Criteria

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

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It has been less than 6 weeks since my last strong cancer treatment.

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My kidney function is low, with a GFR under 30 ml/min.

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I have previously received 177Lu-PSMA-617 therapy.

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I have a blockage in my urinary tract or severe swelling of my kidneys.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of the first cycle of lu 177 vipivotide tetraxetan (177lu-prostate-specific membrane antigen [psma]-617) therapy, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of the first cycle of lu 177 vipivotide tetraxetan (177lu-prostate-specific membrane antigen [psma]-617) therapy, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of the first cycle of lu 177 vipivotide tetraxetan (177lu-prostate-specific membrane antigen [psma]-617) therapy, 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

2-year survival rate

Secondary study objectives

Bone pain level

DCR by combined radiographic + PSA response

Disease control rate (DCR)

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (177Lu-PSMA-617)Experimental Treatment7 Interventions

Patients receive 177Lu-PSMA-617 IV once every 6 weeks on study. Beginning with the third cycle, treatments may be postponed beyond the 6 weeks interval based on defined response criteria ("treatment holiday" period). Treatment repeats every 6 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT throughout the trial. Patients also undergo SPECT/CT, PET/CT, or CT on the trial.

Group II: Arm II (177Lu-PSMA-617)Active Control7 Interventions

Patients receive 177Lu-PSMA-617 IV once every 6 weeks on study. Treatment repeats every 6 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive 68Ga-PSMA-11 IV and undergo PSMA PET/CT throughout the trial. Patients also undergo SPECT/CT, PET/CT, or CT on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PSMA PET Scan

2020

N/A

~10

Computed Tomography

2017

Completed Phase 2

~2740