What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly radiopharmaceutical agents like lutetium Lu 177 vipivotide tetraxetan and radium-223, often have side effects such as bone marrow suppression, leading to anemia, thrombocytopenia, and neutropenia. Other side effects include gastrointestinal issues, fatigue, and dry mouth. Additionally, systemic therapies like androgen receptor pathway inhibitors can cause hot flashes, hypertension, and liver function abnormalities. It's important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved lutetium Lu 177 vipivotide tetraxetan for the treatment of PSMA-positive metastatic castration-resistant prostate cancer (CRPC) based on the VISION trial, which showed significant improvements in radiographic progression-free survival and overall survival. Another similar radiopharmaceutical agent is radium-223 (Ra-223), used for patients with symptomatic bone metastases. These treatments deliver targeted radiation to cancer cells, reducing harm to healthy tissues.

What other types of research exist?

Promising novel alternatives to [177Lu]Ludotadipep for prostate cancer patients include: 1) PSMA-targeted radioligand therapy using agents like [177Lu]Lu-PSMA-617, which has shown success in clinical trials for patients who have exhausted other treatment options. 2) Radium-223 (Ra-223), an alpha particle-emitting agent, which prolongs overall survival and decreases symptomatic skeletal-related events in men with castration-resistant prostate cancer (CRPC) and bone metastases. 3) Beta-emitting radioisotopes such as strontium-89 and samarium-153, which are used for pain palliation in patients with multiple osteoblastic bone metastases. These alternatives offer targeted approaches to treating prostate cancer, potentially improving outcomes for patients.

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Radiopharmaceutical

Lu-177 Ludotadipep for Prostate Cancer (LUCIDA Trial)

Phase 1 & 2

Recruiting

Led By Arif Hussain, MD

Research Sponsored by FutureChem

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 40 weeks (4 to 6 doses at 8-weekly intervals [± 1 week], with 6 week follow-up after each dose (screening up to 28 days)

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of a radioactive drug called [177Lu]Ludotadipep. The drug works by delivering radiation directly to certain cells to treat the condition. Lutetium-177 (177Lu) has been widely used in targeted therapy, particularly in peptide receptor radionuclide therapy (PRRT) for treating neuroendocrine tumors.

Who is the study for?

Men aged 18+ with advanced prostate cancer that has resisted hormone therapy and progressed after treatments like enzalutamide or abiraterone. They must have PSMA positive lesions, be on stable doses of bisphosphonate if applicable, may have had taxane chemotherapy or not based on certain conditions, and should have an expected lifespan of at least 3 months for Phase 1 (6 months for Phase 2a). Participants need to use birth control during the study.

What is being tested?

[177Lu]Ludotadipep is being tested in two phases. Phase 1 aims to find the safest dose by starting with a single injection of 3.7 GBq, possibly lowering it if needed. In Phase 2a, they'll test this dose's safety and effectiveness when given repeatedly based on results from earlier trials.

What are the potential side effects?

Potential side effects are not explicitly listed but typically include reactions related to radiation such as nausea, fatigue, blood count changes which could lead to increased infection risk or bleeding problems; kidney function might also be affected due to the nature of radiopharmaceuticals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 40 weeks (4 to 6 doses at 8-weekly intervals [± 1 week], with 6 week follow-up after each dose (screening up to 28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 40 weeks (4 to 6 doses at 8-weekly intervals [± 1 week], with 6 week follow-up after each dose (screening up to 28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 weeks (4 to 6 doses at 8-weekly intervals [± 1 week], with 6 week follow-up after each dose (screening up to 28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicities (DLT) with a single fixed dose of [177Lu]Ludotadipep during the first cycle (8 [±1] weeks) (Phase 1)

Objective Response Rate (Phase 2a)

Secondary study objectives

Biodistribution: assessment of the absorption (uptake) into the blood, lungs, liver, spleen, pancreas, kidneys, muscle, stomach, and tumor based on the level obtained from whole body scan (WBS) 2 hours, 24 hours, 48 hours, and 7 days post-dose (Phase 1)

Disease Control Rate (Phase 2a)

European Organization for Research and Treatment of Cancer quality of life (EORTC QLQ-C30) questionnaire (Phase 2a)

+7 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: [177Lu]Ludotadipep 3.7 GBqExperimental Treatment1 Intervention

If investigators observed one or no DLT in 6 patients at the 3.7 GBq dose level, the study can advance to the Phase 2a part of the trial after the safety review committee (SRC) review.

Do I qualify?Apply below to find out

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

Radiopharmaceutical agents, such as [177Lu]Ludotadipep and 177Lu-PSMA-617, work by targeting prostate-specific membrane antigen (PSMA) on prostate cancer cells. These agents bind to PSMA and deliver localized radiation to destroy the cancer cells while sparing healthy tissue. This targeted mechanism is significant for prostate cancer patients as it provides a more precise treatment option, potentially improving outcomes and reducing side effects compared to conventional therapies.

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