Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07096128

A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer

This was a multicenter, open-label, phase I study to evaluate the safety, tolerability, radiation dosimetry and efficacy of [177Lu] Lu-PSMA-XT injection in patients with metastatic prostate cancer .

Recruiting

Interested in participating?

Request Info

Key information

Conditions

MCRPC

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have the ability to understand and sign an approved informed consent form (ICF).
  • Patients must be >= 18 and <＝80 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patients must have a life expectancy >6 months.
  • Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
  • Patients must be PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。
  • Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
  • 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.
  • Patients must have progressive mCRPC.
  • Patients must have adequate organ function。
  • 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

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

Treatment and study plan

[177Lu]Lu-PSMA-XT

Drug

[177Lu]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells.

Primary outcomes

  1. 1.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

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

    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.

  2. Dose-limiting toxicity（DLT）

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

    Incidence and severity of dose-limiting toxicities.

  3. Whole body and organ uptake of [177Lu]Lu-PSMA-XT Injection

    Time frame: From the first subject enrolled to one week after the last subject completed the first dosing,assessed up to approximately 12 months

    Quantitate the absorbed radiation doses (expressed as Gy/MBq) of administered [177Lu]Lu-PSMA-XT to kidneys, liver, lungs, spleen, bone/red marrow and salivary glands.

Secondary outcomes

  1. Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level(PCWG3)

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

    Best percentage change from baseline in PSA level was defined as the maximum percent decrease at any time post-baseline.

  2. Prostate-specific Antigen 50 (PSA50) Response

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

    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.

  3. Time to PSA progression

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

    PSA progression was defined as: 1) Where a decline from baseline was documented, date that a >= 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir was documented and confirmed by a second consecutive value obtained at least 3 weeks later. Rises in PSA within the first 12 weeks of the date of first dose were ignored; 2) Where no decline from baseline was documented, PSA progression was defined as a >= 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 weeks from the date of first dose (without confirmation) as specified in the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines.

  4. Radiographic Progression-free Survival (rPFS)

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

    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.

  5. Overall Response Rate (ORR)

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

    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.

  6. Duration of Response (DOR)

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

    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 .

  7. Disease Control Rate (DCR)

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

    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.

  8. Time to First Symptomatic Skeletal Event (SSE)

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

    Time to first Symptomatic Skeletal Event (SSE) was defined as the time (in months) from the date of enrollment to the date of the SSE or death from any cause. The SSE date was the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinming Zhang

CONTACT

[email protected]

(+86)010-66936108

Jinming Zhang

CONTACT

[email protected]

+861066936108

Sponsors and collaborators

Lead sponsor

Jinming Zhang

Other

Collaborators

  • Sinotau Pharmaceutical Group

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.