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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
Disease progression on prior enzalutamide, abiraterone, apalutamide or related agent therapy as defined by meeting specific criteria
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features at initial diagnosis
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

LUCIDA Trial Summary

This trialis testing the safety and effectiveness of a drug, with potential dose level de-escalation, to see if it can be used in repeated doses to treat a condition.

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.Check my eligibility
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.See study design
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.

LUCIDA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has worsened despite treatment with specific hormone therapies.
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My prostate cancer is confirmed and does not have neuroendocrine or small cell features.
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I am a man and 18 years old or older.
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My cancer shows PSMA positive lesions.

LUCIDA Trial 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

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

LUCIDA 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.

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

Frequently Asked Questions

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

Are there any openings left in this clinical experiment?

"Per information found on clinicaltrials.gov, this trial is actively recruiting participants. The initial posting for the study was published on September 1st 2022 and new data was last added to the page on December 8th 2022."

Answered by AI

How many research centers are currently carrying out this trial?

"Currently, 4 medical centres are recruiting participants for this clinical trial. Gettysburg, Los Angeles and Towson as well as other cities have outlets for the study to be conducted in. To reduce commuting time and cost, it is advisable that you select a centre closest to your place of residence."

Answered by AI

To what extent has the participant count in this research reached?

"Affirmative. According to clinicaltrials.gov, this medical trial is recruiting participants as of today - the project was first announced on September 1st 2022 and updated most recently at December 8th 2022. Up to 26 patients are being accepted for testing across 4 sites."

Answered by AI

What is the primary objective of this trial?

"According to the project sponsor, FutureChem, this clinical trial will measure outcomes over one single dose and 8 weeks of follow-up (screening up to 28 days). The primary outcome is Objective Response Rate (Phase 2a), while secondary outcomes include Safety Assessments (Phase 1) - which involve recording Adverse Events from signing an Informed Consent Form, laboratory tests, ECG readings, vitals signs etc. - Disease Control Rates (DCRs = Complete Response Rate + Partial Response Rate + Stable Disease Rate), as well as Safety assessments in Phase 2a."

Answered by AI
~5 spots leftby Aug 2024