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Lu-177 Ludotadipep for Prostate Cancer (LUCIDA Trial)
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.
LUCIDA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLUCIDA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LUCIDA Trial Design
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Who is running the clinical trial?
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- I have not had a blood clot in the past 3 months.I have brain metastasis or active leptomeningeal disease.I haven't had cancer treatment in the last 4 weeks, with some exceptions.I have been on a stable dose of bisphosphonate for at least 4 weeks.I have not had a serious infection in the last 14 days.I have had radiation treatment to half of my body.I have not had major surgery in the last 4 weeks.I have used blood thinners in the last 3 months due to a clotting condition.I haven't used herbal products that lower PSA levels in the last 30 days.I have a history of HIV or hepatitis B/C.I plan to start a different treatment or join another clinical trial for my prostate cancer during this study.I am a man and 18 years old or older.My cancer shows PSMA positive lesions.I can care for myself and am up and about more than 50% of my waking hours.My doctor thinks another treatment is better for me than this study.My cancer has worsened despite treatment with specific hormone therapies.I have tested positive for COVID-19 or shown symptoms in the last 5 days.My lab tests show my organs are not working properly.I haven't had cancer in the last 3 years, except for skin or early bladder cancer.I have not had severe heart failure or uncontrolled high blood pressure in the last 6 months.My prostate cancer is confirmed and does not have neuroendocrine or small cell features.I haven't taken any experimental drugs recently.
- Group 1: [177Lu]Ludotadipep 3.7 GBq
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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