Prostate CancerPhase 1/2NCT07689656
A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
A Phase 1/2 study testing [68Ga]Ga-ELI421 injection in people with Prostate Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Primary Objective: To evaluate the safety and tolerability of PET imaging following a single intravenous infusion of [⁶⁸Ga]Ga-ELI421 injection in patients with prostate cancer. Secondary Objectives: To evaluate the biodistribution characteristics of [⁶⁸Ga]Ga-ELI421 injection; To evaluate the radiation dosimetry… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- [68Ga]Ga-ELI421 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2026to 30 Dec 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has been fully informed about the study and voluntarily provided written informed consent prior to initiation of any study-related procedures;
- Aged ≥ 18 years;
- In generally good condition with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Patients with histopathologically and/or cytologically confirmed prostate cancer;
- Has an indication for PSMA PET imaging;
- 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.
- 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.
Who cannot join
- Presence of comorbidities that may compromise subject safety or interfere with imaging results;
- Concomitant medications that may compromise subject safety or interfere with imaging results;
- Insufficient washout period following prior anti-tumor therapies (including cytotoxic chemotherapy, immunotherapy, radiotherapy, etc.), which may compromise subject safety or interfere with imaging results;
- Known hypersensitivity to ionizing radiation or alcohol, or hypersensitivity to [⁶⁸Ga]Ga-ELI421 injection or its excipients, or other history of severe allergic reactions;
- Inability to complete PET imaging as required;
- Any other conditions deemed inappropriate by the investigator for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Chunxia Qin, +86-27-83692633, qin_chunxia@hust.edu.cn
About this study
Official title: A Clinical Study on the Safety and Tolerability, Biodistribution, Radiation Dosimetry, and Diagnostic Efficacy of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer
Primary Objective:
To evaluate the safety and tolerability of PET imaging following a single intravenous infusion of [⁶⁸Ga]Ga-ELI421 injection in patients with prostate cancer.
Secondary Objectives:
To evaluate the biodistribution characteristics of [⁶⁸Ga]Ga-ELI421 injection; To evaluate the radiation dosimetry characteristics of [⁶⁸Ga]Ga-ELI421 injection; To evaluate the diagnostic efficacy of PET imaging with [⁶⁸Ga]Ga-ELI421 injection.
- Conditions
- Prostate Cancer
- Being tested
- [68Ga]Ga-ELI421 injection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-ELI421 injectionDrug
Administration Protocol: A single rapid intravenous bolus injection of [68Ga]Ga-ELI421 injection at a radioactivity dose of about 185 MBq (5 mCi), followed by catheter flushing with approximately 10 mL of 0.9% sterile normal saline. Static scanning and/or dynamic scanning Whole-body PET Imaging will be performed. PSMA PET imaging will be performed in accordance with routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm with Dual PET Imaging: ELI421 and PSMA PET for Prostate Cancer | Experimental | Not described Receives: Drug: [68Ga]Ga-ELI421 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE)
Any abnormality, medication, or treatment after dosing shall be documented as an adverse event and concomitant medication / non-pharmacological treatment. All adverse events shall be followed up until resolution, stabilization or remission of symptoms, or until abnormal laboratory values return to normal, baseline or a stable state, or until a reasonable explanation is obtained (e.g., loss to follow-up, death).
Measured: Day1, Day2-3
Secondary outcomes (3)
Lesion uptake value
ROIs shall be delineated to calculate the percentage injected dose (%ID), mean standardized uptake value (SUVmean), and retention time of target organs/tissues at various scanning time points.
Measured: Day1
Absorbed dose
Absorbed dose of target organs/tissues and total-body effective dose.
Measured: Day1
Diagnostic performance
Diagnostic performance of [⁶⁸Ga]Ga-ELI421 for lesion detection compared with PSMA PET, including the number of lesions and diagnostic performance indicators such as accuracy, sensitivity, and specificity.
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start8 Jun 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Radiopharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689656
- Sponsor's protocol ID
- Xlan-20260318
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No