Ga-ELI421 PET imaging in prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional early-phase study (Phase 1/2) evaluating a single intravenous injection of [68Ga]Ga-ELI421 for PET imaging in adults with histologically confirmed prostate cancer. The trial will assess safety and tolerability, how the tracer distributes in the body, the radiation dosimetry, and whether the imaging provides useful diagnostic information. Participants will undergo PET imaging after injection and will be closely monitored for adverse events and imaging quality. The study is conducted at Union Hospital in Wuhan, with Eli Radiopharma as a collaborator.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Has been fully informed about the study and voluntarily provided written informed consent prior to initiation of any study-related procedures;
2. Aged ≥ 18 years;
3. In generally good condition with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
4. Patients with histopathologically and/or cytologically confirmed prostate cancer;
5. Has an indication for PSMA PET imaging;
6. No clinically significant abnormal findings on physical examination, vital signs, laboratory tests, 12-lead ECG, or other examinations that may compromise subject safety or imaging results.
7. Subjects of reproductive potential agree to refrain from pregnancy, sperm donation, and voluntarily use highly effective contraceptive methods (including by their partner) for 6 months after study drug administration, such as condoms, oral or injectable contraceptives, intrauterine devices (IUDs), etc.

Exclusion Criteria:

1. Presence of comorbidities that may compromise subject safety or interfere with imaging results;
2. Concomitant medications that may compromise subject safety or interfere with imaging results;
3. Insufficient washout period following prior anti-tumor therapies (including cytotoxic chemotherapy, immunotherapy, radiotherapy, etc.), which may compromise subject safety or interfere with imaging results;
4. Known hypersensitivity to ionizing radiation or alcohol, or hypersensitivity to \[⁶⁸Ga\]Ga-ELI421 injection or its excipients, or other history of severe allergic reactions;
5. Inability to complete PET imaging as required;
6. Any other conditions deemed inappropriate by the investigator for participation in this study.

Where it's running

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Xiaoli Lan
• Email: hzslxl@163.com
• Phone: +86-2783692633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.