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Radiation

177Lu-PSMA with Biopsy for Prostate Cancer

Phase 1

Waitlist Available

Led By Johannes Czernin

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

Histologically confirmed prostate cancer

Evidence of lymph node or soft tissue metastatic disease amenable to image-guided biopsy based on positron emission tomography (PET)/computed tomography (CT) images

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of cycle 2 before the initiation of cycle 3 of rlt (cycle is six weeks)

Awards & highlights

Study Summary

This trial looks at how well a treatment, 177Lu-PSMA, works to kill prostate cancer cells that have spread to other parts of the body. Doctors will do image guided biopsies to help learn how well the treatment works.

Who is the study for?

This trial is for men with advanced prostate cancer that no longer responds to hormone therapy and has spread. Participants must have a confirmed diagnosis, be willing volunteers, eligible for 177Lu-PSMA treatment, and have metastatic disease suitable for biopsy. They need adequate blood clotting function and may need to stop certain medications like blood thinners before the biopsy.Check my eligibility

What is being tested?

The study is examining how well a targeted radioactive drug therapy (177Lu-PSMA) works by using image-guided biopsies on tumors. The goal is to understand why some cancers resist this treatment and use this information to improve future therapies.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of image-guided biopsies can include pain at the biopsy site, bleeding, infection risk, and reactions related to sedation or anesthesia used during the procedure.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer diagnosis was confirmed through a tissue examination.

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My scans show cancer spread to lymph nodes or tissues that can be biopsied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of cycle 2 before the initiation of cycle 3 of rlt (cycle is six weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of cycle 2 before the initiation of cycle 3 of rlt (cycle is six weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of cycle 2 before the initiation of cycle 3 of rlt (cycle is six weeks) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Biopsy

Secondary outcome measures

Proportion of patients with gene mutations that might confer resistance to RLT

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (image-guided biopsy)Experimental Treatment1 Intervention

Patients undergo an image-guided biopsy at baseline and 2-4 weeks after cycle 2 of 177Lu-PSMA-617 therapy.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,045 Total Patients Enrolled

39 Trials studying Prostate Cancer

4,000 Patients Enrolled for Prostate Cancer

Johannes CzerninPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

2 Previous Clinical Trials

400 Total Patients Enrolled

Media Library

177Lu-PSMA (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05398302 — Phase 1

Prostate Cancer Research Study Groups: Diagnostic (image-guided biopsy)

Prostate Cancer Clinical Trial 2023: 177Lu-PSMA Highlights & Side Effects. Trial Name: NCT05398302 — Phase 1

177Lu-PSMA (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05398302 — Phase 1

Frequently Asked Questions

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

Has the FDA endorsed Image Guided Biopsy as a reliable diagnostic tool?

"Taking into account its Phase 1 status, our team at Power has concluded that the safety of Image Guided Biopsy is best estimated as a 1. This implies there exists limited evidence to support both efficacy and security."

Answered by AI

Is there a recruitment process for this clinical research still underway?

"As evidenced on clinicaltrials.gov, the recruitment phase of this trial has ended. Posted initially on March 31st 2023 and last edited November 14th 2022, it does not currently seek participants; however, there are 3656 other studies actively recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Image-Guided Biopsies to Identify Mechanisms of Resistance in Patients With Metastatic Castration Resistant Prostate Cancer Treated With 177Lu-PSMA Radioligand Therapy

2024. "Image-Guided Biopsies to Identify Mechanisms of Resistance in Patients With Metastatic Castration Resistant Prostate Cancer Treated With 177Lu-PSMA Radioligand Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05398302.