Treating metastatic prostate cancer with [177Lu] Lu-PSMA-XT injection

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 multicenter, open-label Phase 1 study gives [177Lu] Lu-PSMA-XT to men with progressive mCRPC who are PSMA-PET positive and meet enrollment criteria including castrate testosterone and ECOG 0–1. The primary focus is on safety, tolerability, and radiation dosimetry, with secondary observation of early anti-tumor activity across dose levels. Enrolled patients typically have received prior novel antiandrogens and one to two taxane regimens or are deemed unsuitable for taxanes; dosing schedules and follow-up visits are defined in the protocol. Participants will undergo imaging, laboratory testing, and clinical exams to monitor radiation exposure, adverse events, and tumor response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients must have the ability to understand and sign an approved informed consent form (ICF).
2. Patients must be \>= 18 and \<＝80 years of age.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Patients must have a life expectancy \>6 months.
5. Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
6. Patients must be PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。
7. Patients must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
8. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone)； patients must have been previously treated undergone at least 1-2 prior taxane-based chemotherapy regimens or be unsuitable for taxane therapy (unsuitability includes contraindications, investigator-determined ineligibility, or patient refusal) in mCRPC stage.
9. Patients must have progressive mCRPC.
10. Patients must have adequate organ function。
11. Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.

Exclusion Criteria:

1. Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
2. Known other malignancies.
3. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
4. Known hypersensitivity to the components of the study therapy or its analogs.
5. A superscan as seen in the baseline bone scan.
6. Patients with a history of Central Nervous System (CNS) metastases.
7. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Mianyang Central Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Medical Center, Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Jinming Zhang — The First Medical Center, Chinese PLA General Hospital
• Study coordinator: Jinming Zhang
• Email: Zhangjm301@163.com
• Phone: (+86)010-66936108

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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.