An exploratory study of 177Lu-PSMA-EB-01 in patients with prostate specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200065809

Enrollment

Unknown

Registered

2022-11-15

Start date

2022-11-15

Completion date

Unknown

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

Experimental group 1:Dose 60mCi 177Lu-PSMA-EB-01

Experimental group 2:Dose 100mCi 177Lu-PSMA-EB-01

Eligibility

Sex/Gender

Male

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patient can understand and voluntarily sign the approved informed consent form (ICF); 2. Aged 18-75 years; 3. Metastatic castration resistant prostate cancer (mCRPC); 4. The patient must be diagnosed as prostate cancer by histology, pathology and/or cytology, and the clinical routine treatment (including endocrine therapy, chemotherapy, radiotherapy, new androgen inhibitors, etc.) is ineffective or advanced; 5. Estimated life span > 6 months; 6. ECOG score = 2.5 x 10 ^ 9/L; (2) Platelet >= 100 x 10 ^ 9/L; (3) Hemoglobin >= 9 g/dL; (4) Total bilirubin = 50 mL/min; 9. All other existing toxicity levels shall be <= NCI-CTCAE v5.0 Level 0 or 1.

Exclusion criteria

Exclusion criteria: 1. Patients who have received radionuclide therapy within 6 months; 2. Patients receiving chemotherapy, radiotherapy, immunotherapy and clinical trial drugs within 28 days; 3. Allergic constitution, or allergy to known research drug ingredients or excipients; 4. Operators suffering from claustrophobia or unable to tolerate imaging examination due to other reasons; 5. Active infection with clinical significance judged by the researcher; 6. Previous or current uncontrolled primary or metastatic brain tumor; 7. Suffer from serious and/or poorly controlled and/or unstable diseases that may affect the study in the judgment of the researcher, including but not limited to: (1) Poorly controlled diabetes; (2) Congestive heart failure; (3) Myocardial infarction in the past 12 months; (4) Unstable and uncontrollable hypertension; (5) Chronic kidney disease or liver disease; (6) Severe lung disease; 8. Subjects with poor compliance who are expected to be unable to cooperate in completing the test procedure; 9. Other subjects considered by the investigator to be unsuitable for the clinical study.

Design outcomes

Primary

Measure	Time frame
Overall Survival;Adverse reactions;Progression-Free Survival;Karnofsky;Numerical Rating Scale;	—

Countries

China

Contacts

Public ContactYue Chen

The Affiliated Hospital of Southwest Medical University

chenyue5523@126.com+86 830 3165720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026