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

A Phase I Study to Assess the Safety, Tolerability, Radiation Dosimetry and Efficacy of [177Lu] Lu-PSMA-XT in Patients With Metastatic Prostate Cancer

This trial tests a radioactive PSMA-targeting injection called [177Lu] Lu-PSMA-XT in men with metastatic castration-resistant prostate cancer to see if it is safe, tolerable, and can help control the cancer.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Chinese PLA General Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT07096128 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men with progressive metastatic castration-resistant prostate cancer who are PSMA-PET positive, have castrate-level testosterone, ECOG 0–1, are aged 18–80, have prior novel antiandrogen therapy and one to two taxane regimens (or are unsuitable for taxanes), and have life expectancy over six months.

Not a fit: Patients with PSMA-negative disease, poor performance status (ECOG ≥2), very limited life expectancy, or contraindications to radioligand therapy are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this targeted radioligand could deliver radiation directly to PSMA-expressing cancer cells and potentially shrink tumors or slow disease progression with manageable side effects.

How similar studies have performed: Other Lu-177 PSMA radioligand therapies (for example [177Lu]Lu-PSMA-617) have shown meaningful clinical benefit in mCRPC, so the general approach has clinical precedent though this specific agent is early-stage.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 2 other locations

• 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

Conditions: mCRPC, 177Lu, PSMA