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RecruitingNCT07135102Updated Aug 24, 2025

A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer

A Phase 1 interventional study of 225Ac-PSMA-XT in Metastatic Castration-Resistant Prostate Cancer Patients, sponsored by Xiaorong Sun. Recruiting at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-24.

Sponsored by Xiaorong Sun · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2024, registered Aug 2025).
  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC

02

Conditions studied

  • Metastatic Castration-Resistant Prostate Cancer Patients
03

In context

Lead sponsor

Xiaorong Sun is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. have the ability to understand and sign an approved informed consent form (ICF).
  2. >= 18 years old.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. have a life expectancy >6 months.
  5. have histological, pathological, and/or cytological confirmation of prostate cancer.
  6. PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive
  7. have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
  8. 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. progressive mCRPC.
  10. 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

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.

    Known other malignancies.

  2. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
  3. Known hypersensitivity to the components of the study therapy or its analogs.
  4. A superscan as seen in the baseline bone scan.
  5. Patients with a history of Central Nervous System (CNS) metastases.
  6. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    225Ac-PSMA-XT treatment

    Drug: 225Ac-PSMA-XT

Interventions

  • Drug225Ac-PSMA-XT

    Patients will receive 225Ac-PSMA-XT administration at an interval of 6 weeks between each dose.

06

What researchers measure

Primary outcomes

  1. Treatment emergent adverse events

    To evaluate the safety and tolerability of \[177Lu\]Lu-PSMA-XT Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc.

    Time frame: Through study completion, assessed up to 2 years

  2. Dose-limiting toxicity（DLT）

    Incidence and severity of dose-limiting toxicities.

    Time frame: Through study completion, assessed up to 2 years

Secondary outcomes

  1. Prostate-specific Antigen 50 (PSA50) Response

    PSA50 response was defined as the proportion of participants who had a \>= 50% decrease in PSA from baseline confirmed by a PSA measurement \>= 4 weeks later.

    Time frame: Through study completion, assessed up to 2 years.

  2. Radiographic Progression-free Survival (rPFS)

    Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of enrollment to the date of radiographic disease progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause.

    Time frame: Through study completion, assessed up to 2 years.

  3. Overall Response Rate (ORR)

    Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline.

    Time frame: Through study completion, assessed up to 2 years.

  4. Duration of Response (DOR)

    Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause .

    Time frame: Through study completion, assessed up to 2 years.

  5. Disease Control Rate (DCR)

    Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1.

    Time frame: Through study completion, assessed up to 2 years.

07

Study locations

1 of 1 sites recruiting
  • Cancer Hospital of Shandong First Medical University
    Jinan, Shandong 100023, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07135102
Lead sponsor
Xiaorong Sun
Responsible party
Xiaorong Sun (Director of Nuclear Medicine Department, Shandong Cancer Hospital and Institute) — Sponsor-investigator
First posted
Aug 21, 2025
Start date
Oct 14, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Aug 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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