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Radiation

Arm II (177Lu-PSMA-617 treatment pause) for Prostate Cancer

Phase 2

Recruiting

Led By Matthew P. Thorpe, M.D., Ph.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

PSMA positive metastatic castration resistant prostate cancer (miPSMA score >= 2 on Mayo PET report)

Dry mouth limiting oral intake to purees or soft/moist foods

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how to improve the use of a treatment called Lu 177 vipivotide tetraxetan for patients with prostate cancer that has spread to other parts of the body. The

Who is the study for?

This trial is for patients with metastatic castrate-resistant prostate cancer. Participants should have a type of tumor that can be targeted by the drug being tested. The specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.Check my eligibility

What is being tested?

The study is testing whether giving a radioactive drug called Lutetium Lu 177 Vipivotide Tetraxetan (177Lu-PSMA-617) for five treatment cycles is as effective as the standard six cycles in treating prostate cancer that has spread.See study design

What are the potential side effects?

Possible side effects may include radiation-related symptoms such as fatigue, nausea, and potential damage to non-cancerous cells. Specific side effects of Lutetium Lu 177 Vipivotide Tetraxetan are not detailed here.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is advanced, resistant to hormonal therapy, and PSMA positive.

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I can only eat purees or soft foods due to dry mouth.

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My prostate cancer diagnosis was confirmed through a tissue examination.

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I am referred to Mayo Clinic Rochester for a specific cancer treatment.

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I have been treated with drugs targeting the androgen receptor and chemotherapy based on taxane.

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I am able to care for myself and perform daily activities.

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My liver enzymes are within the required limits.

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I have no side effects that would require a lower dose of my next 177Lu PSMA-617 treatment.

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

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I experience fatigue that rest doesn't help, affecting my daily activities.

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My cancer shows up on a special PET scan.

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My scans show almost no cancer after treatment with 177Lu PSMA-617.

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My kidneys are functioning well enough, based on a specific test.

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I need help or treatment for my severe diarrhea, nausea, or constipation.

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

Progression-free survival

Secondary outcome measures

Incidence of adverse events

Overall survival

Time to progression (TTP)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (177Lu-PSMA-617 treatment pause)Experimental Treatment9 Interventions

Patients receive 177Lu-PSMA-617 IV over 10-15 minutes on day 1 of each cycle. Cycles repeat every 42 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo clinical observation until documented first progression. Patients may resume treatment with 77Lu-PSMA-617. Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo PET/CT and a bone scan during screening and on the trial. Patients also undergo SPECT/CT and blood sample collection on the trial.

Group II: Arm I (177Lu-PSMA-617 standard)Active Control8 Interventions

Patients receive 177Lu-PSMA-617 IV over 10-15 minutes on day 1 of each cycle. Cycles repeat every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo PET/CT and a bone scan during screening and on the trial. Patients also undergo SPECT/CT and blood sample collection on the trial.

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

Biospecimen Collection

2004

Completed Phase 2

~1720

Positron Emission Tomography

2008

Completed Phase 2

~2210

Single Photon Emission Computed Tomography

2008

Completed Phase 4

~310

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,234 Previous Clinical Trials

3,771,611 Total Patients Enrolled

34 Trials studying Prostate Cancer

8,388 Patients Enrolled for Prostate Cancer

Matthew P. Thorpe, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester

Frequently Asked Questions

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

Has the FDA granted approval for Arm II, which involves a temporary cessation of 177Lu-PSMA-617 treatment?

"Arm II, which involves the temporary suspension of 177Lu-PSMA-617 treatment, is considered to be safe according to our team at Power. This rating of 3 is based on it being a Phase 4 trial and indicates that the treatment has already received approval."

Answered by AI

Is this medical research study currently open for enrollment?

"According to the information available on clinicaltrials.gov, this particular trial is currently not seeking patients. The initial posting date was February 1st, 2024 and the most recent update occurred on December 28th, 2023. However, it's important to note that there are currently 1215 other trials actively recruiting participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer

2024. "Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06200103.

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