Study on [Lu-177]Ludotadipep for Treating Castration-resistant Prostate Cancer
Sponsor: FutureChem
ClinicalTrials ID:NCT05458544
This clinical trial is testing a new treatment called [Lu-177]Ludotadipep for men with castration-resistant prostate cancer. The study aims to determine the safety and effectiveness of this treatment in different phases.
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Program Overview
The study is divided into two parts: Phase 1 and Phase 2a. In Phase 1, the goal is to find a safe dose of [Lu-177]Ludotadipep by testing different amounts to see which is best tolerated by patients. In Phase 2a, the study will evaluate how well the treatment works when given repeatedly at the recommended dose from Phase 1. The study will be conducted in South Korea, and the results will be reviewed with the FDA to determine the best dose for further research.
Description
In Phase 1, patients will first attend a screening visit to determine if they are eligible to participate. This includes a PET/CT scan to check for specific markers in the cancer. Eligible patients will receive a single dose of [Lu-177]Ludotadipep. To prevent side effects, cooling therapies will be applied to the salivary glands, and an amino acid solution will be given to protect the kidneys. Patients will be monitored for side effects and other health measures over an 8-week period, with follow-up visits scheduled at 1, 2, 4, and 8 weeks after treatment. If patients respond well, they may receive additional treatments.
In Phase 2a, the process is similar, but patients will receive repeated doses of [Lu-177]Ludotadipep every 8 weeks, up to 6 times. They will have regular follow-up visits to monitor their health and the treatment's effects. Long-term follow-up will continue every 6 months for 2 years, and possibly up to 10 years, to monitor for any serious side effects or new health issues.
Eligibility Criteria
Inclusion Criteria
- Male, aged 18 or older.
- Diagnosed with prostate cancer without certain aggressive features.
- Cancer has progressed despite previous treatments like enzalutamide or abiraterone.
- Low testosterone levels, possibly receiving ongoing hormone therapy.
- Cancer shows specific markers on scans.
- Stable on bisphosphonate therapy if applicable.
- Either received or are ineligible for taxane-based chemotherapy.
- ECOG performance status of 0 to 2 for Phase 1 and 0 to 1 for Phase 2a.
- Life expectancy of at least 3 months for Phase 1 and 6 months for Phase 2a.
- Agree to use effective birth control if applicable.
- Willing to provide informed consent and follow study requirements.
Exclusion Criteria
- Impaired organ function based on specific blood test results.
- Certain heart conditions or abnormal heart rhythms.
- Sjogren's syndrome.
- Known or suspected brain metastasis.
- History of other cancers within the last 3 years, except certain skin or bladder cancers.
- Recent serious infections or active COVID-19 infection.
- Medical conditions that could interfere with the study.
- Recent heart failure or heart attack.
- Recent anti-tumor therapy, except certain ongoing treatments.
- Previous treatments with specific radioactive therapies or major surgeries.
- Use of anticoagulants for certain conditions.
- Recent use of herbal products affecting PSA levels.
- Participation in other clinical trials or use of investigational drugs recently.
- Known HIV, hepatitis B, or C infections unless well-controlled.
- Vulnerable populations, such as study staff or their families.
- Recent use of investigational medical devices.
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