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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 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.

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.

Find a Location

Who is running the clinical trial?

FutureChemLead Sponsor
5 Previous Clinical Trials
545 Total Patients Enrolled
Arif Hussain, MDPrincipal InvestigatorUniversity of Maryland Medical System
3 Previous Clinical Trials
91 Total Patients Enrolled
3 Trials studying Prostate Cancer
91 Patients Enrolled for Prostate Cancer

Media Library

[177Lu]Ludotadipep (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT05458544 — Phase 1 & 2
Prostate Cancer Research Study Groups: [177Lu]Ludotadipep 3.7 GBq
Prostate Cancer Clinical Trial 2023: [177Lu]Ludotadipep Highlights & Side Effects. Trial Name: NCT05458544 — Phase 1 & 2
[177Lu]Ludotadipep (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05458544 — Phase 1 & 2
~6 spots leftby Jun 2025