What is the mechanism of action of this treatment?

Common treatments for prostate cancer include androgen deprivation therapy (ADT), chemotherapy, and radioconjugates like Lutetium Lu 177 dotatate. Radioconjugates work by binding to specific receptors on cancer cells, such as somatostatin receptors, and delivering targeted radiation to kill these cells. This mechanism is particularly important for prostate cancer patients with neuroendocrine differentiation, as these cells often express somatostatin receptors. Understanding this helps in selecting effective treatments and personalizing therapy, thereby improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer, especially those similar to Lutetium Lu 177 dotatate, often have side effects such as fatigue, nausea, and dry mouth. Radioconjugate therapies like Lutetium Lu 177 dotatate can also cause hematologic toxicities, including anemia and neutropenia, and nephrotoxicity, which affects kidney function. Other systemic treatments, such as hormonal therapies, may lead to hot flashes, decreased libido, and bone thinning, while chemotherapy can result in hair loss, gastrointestinal issues, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including radioconjugates and other targeted therapies. One notable radioconjugate is Radium-223 (Ra-223), which targets bone metastases in castration-resistant prostate cancer (CRPC). While Lutetium Lu 177 dotatate specifically targets somatostatin receptors and is being studied for its efficacy in neuroendocrine-differentiated prostate cancer, other approved treatments for CRPC include androgen receptor inhibitors like enzalutamide and abiraterone, as well as chemotherapeutic agents such as docetaxel. These treatments aim to manage advanced stages of prostate cancer by targeting different pathways involved in cancer progression.

What other types of research exist?

Promising alternatives to Lutetium Lu 177 dotatate for prostate cancer treatment include: 1) Radium-223, which targets bone metastases and has shown improved survival rates in combination with other therapies. 2) Beta-emitting radioisotopes like Strontium-89 and Samarium-153, which are used for pain palliation in bone metastases. 3) Combination therapies such as Ra-223 with abiraterone or enzalutamide, which have shown potential in improving survival and reducing fracture risk. 4) Investigational approaches like multitargeted kinase inhibitors (e.g., regorafenib, cabozantinib) that target VEGFR and other kinases, showing some activity in advanced cases.

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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 should be New York Heart Association Functional Classification of class 2B or better

Patients must have metastatic prostate cancer with neuroendocrine differentiation, as determined by at least one of the specified criteria

Must not have

History of allergic reactions attributed to compounds of similar composition to Lutetium Lu 177 dotatate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well lutetium Lu 177 dotatate works in treating patients with a specific type of prostate cancer that has spread. The drug targets cancer cells and releases radiation to kill them. Lutetium-177 (Lu-177) PSMA therapy is a targeted treatment for advanced prostate cancer that has shown promising results.

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.

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.

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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My heart condition does not severely limit my daily activities.

Select...

My prostate cancer has spread and shows neuroendocrine features.

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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 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.

Exclusion Criteria

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

Select...

I am allergic to medications similar to Lutetium Lu 177 dotatate.

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

Objective response rate (ORR)

Secondary study objectives

Change in FDG-PET signal

Radiographic progression-free survival (rPFS)

Treatment response

Other study objectives

Gene expression levels of circulating tumor cells

Patient-specific dosimetry of lutetium Lu 177 dotatate

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 (lutetium Lu 177 dotatate)Experimental Treatment5 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 receive gallium Ga 68-dotatate IV during screening then 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

Positron Emission Tomography

2011

Completed Phase 2

~2200

Gallium Ga 68-DOTATATE

2018

Completed Phase 2

~30

Computed Tomography

2017

Completed Phase 2

~2740

Biospecimen Collection

2004

Completed Phase 3

~2020

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), chemotherapy, and radioconjugates like Lutetium Lu 177 dotatate. Radioconjugates work by binding to specific receptors on cancer cells, such as somatostatin receptors, and delivering targeted radiation to kill these cells. This mechanism is particularly important for prostate cancer patients with neuroendocrine differentiation, as these cells often express somatostatin receptors. Understanding this helps in selecting effective treatments and personalizing therapy, thereby improving patient outcomes.

Biomarkers to personalize treatment with 177Lu-PSMA-617 in men with metastatic castration-resistant prostate cancer - a state of the art review.