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Radioactive Drug

Radioactive Drug Therapy for Prostate Cancer

Phase 2
Recruiting
Led By John M Floberg
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a prior or concurrent malignancy that does not interfere with the safety or efficacy assessment of the investigational regimen are eligible
Patients should be New York Heart Association Functional Classification of class 2B or better
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial studies how well a radioactive drug can treat prostate cancer that has spread to other places in the body. It may carry radiation directly to tumor cells, without damaging normal cells.

Who is the study for?
This trial is for adults with metastatic prostate cancer that has neuroendocrine cells. Participants must not be using other cancer treatments, should have good organ function and performance status, and agree to use contraception. Those with controlled HIV or hepatitis, treated brain metastases, or a second malignancy not affecting the study can join.Check my eligibility
What is being tested?
The trial tests Lutetium Lu 177 dotatate's effectiveness in shrinking tumors in patients with advanced prostate cancer having neuroendocrine differentiation. It involves collecting biospecimens and imaging through CT and PET scans to observe treatment outcomes.See study design
What are the potential side effects?
Potential side effects of Lutetium Lu 177 dotatate include reactions related to radiation exposure such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, kidney damage, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have another cancer that won't affect this treatment's safety or results.
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My heart condition does not severely limit my daily activities.
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I am HIV-positive, on treatment, and my viral load is undetectable.
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My blood, kidney, and liver functions are all within normal ranges.
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My prostate cancer has spread and shows neuroendocrine features.
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I am on medication to keep my testosterone low, or I've had surgery to remove my testicles.
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I will have a special scan and must test positive to continue with my treatment.
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I am not using any other cancer treatments.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I have chronic hepatitis B but it's under control with treatment.
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I had hepatitis C but am now cured or have no detectable virus while on treatment.
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My treated brain metastases are not getting worse according to recent scans.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Change in FDG-PET signal
Radiographic progression-free survival (rPFS)
Treatment response
Other outcome measures
Gene expression levels of circulating tumor cells
Patient-specific dosimetry of lutetium Lu 177 dotatate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (lutetium Lu 177 dotatate)Experimental Treatment4 Interventions
Patients receive lutetium Lu 177 dotatate IV over 30 minutes. Cycles repeat Q6W for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT scan at baseline and collection of blood throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Positron Emission Tomography
2008
Completed Phase 2
~2260

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,317 Total Patients Enrolled
John M FlobergPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO

Media Library

Lutetium Lu 177 Dotatate (Radioactive Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05691465 — Phase 2
Prostate Carcinoma Research Study Groups: Treatment (lutetium Lu 177 dotatate)
Prostate Carcinoma Clinical Trial 2023: Lutetium Lu 177 Dotatate Highlights & Side Effects. Trial Name: NCT05691465 — Phase 2
Lutetium Lu 177 Dotatate (Radioactive Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05691465 — Phase 2

Frequently Asked Questions

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

Has lutetium Lu 177 dotatate achieved regulatory approval from the FDA?

"The safety of lutetium Lu 177 dotatate was rated 2 on the 1-3 scale since this is only a phase 2 trial, with some data indicating its safety but none confirming its efficacy."

Answered by AI

Are there any opportunities for participation in this trial currently available?

"This clinical trial is still searching for participants, as evidenced by the listing on clinicaltrials.gov. It was first advertised on April 24th of 2023 and has since been revised on May 9th of the same year."

Answered by AI

What is the current enrolment figure for this trial?

"Confirmed. Evidenced on clinicaltrials.gov, this research trial is presently recruiting participants and was posted to the platform on April 24th 2023 with a subsequent update made May 9th of the same year. A total of 25 patients are desired from 1 medical centre for enrolment in this study."

Answered by AI
~20 spots leftby Nov 2024