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mCRPCPhase 1NCT07096128

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

A Phase 1 study testing [177Lu]Lu-PSMA-XT in people with mCRPC, run by Jinming Zhang at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 . Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
mCRPC
What is being tested?
[177Lu]Lu-PSMA-XT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
3 sitesChina
Study dates
20 Aug 2024to 30 Apr 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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。
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jinming Zhang contact

(+86)010-66936108

Zhangjm301@163.com

Jinming Zhang contact

+861066936108

Zhangjm301@163.com

China3 sites, 3 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100000

    Zhi Yang, 010-88196196, pekyz@163.com

    Zhi Yang

    Recruiting

  • Mianyang Central Hospital

    Beijing, Beijing Municipality, 100000

    Zhengguo Chen, 081-66390761, maiwang342@163.com

    Zhengguo Chen

    Recruiting

  • The First Medical Center, Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100000

    Jinming Zhang, (+86)010-66936108, Zhangjm301@163.com

    Jinming Zhang

    Recruiting

Other trials in China

About this study

Official 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

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 .

Conditions
mCRPC
Being tested
[177Lu]Lu-PSMA-XT
Keywords
mCRPC, 177Lu, PSMA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [177Lu]Lu-PSMA-XTDrug

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

Study groups in NCT07096128
Study groupRoleWhat they receive
[177Lu]Lu-PSMA-XTExperimental[177Lu]Lu-PSMA-XT is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells
Receives: Drug: [177Lu]Lu-PSMA-XT

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Through study completion, assessed up to 2 years

  2. Dose-limiting toxicity（DLT）

    Incidence and severity of dose-limiting toxicities.

    Measured: Through study completion, assessed up to 2 years

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

    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.

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

Secondary outcomes (8)

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

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

    Measured: Through study completion, assessed up to 2 years.

  2. 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.

    Measured: Through study completion, assessed up to 2 years.

  3. Time to PSA progression

    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.

    Measured: Through study completion, assessed up to 2 years.

  4. 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.

    Measured: Through study completion, assessed up to 2 years.

  5. 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.

    Measured: Through study completion, assessed up to 2 years.

  6. 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 .

    Measured: Through study completion, assessed up to 2 years.

  7. 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.

    Measured: Through study completion, assessed up to 2 years.

  8. Time to First Symptomatic Skeletal Event (SSE)

    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.

    Measured: Through study completion, assessed up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start20 Aug 2024
  3. Primary completion31 May 2026 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07096128
Sponsor's protocol ID
IIT-XTR021-1-03
Status last verified
Jul 2025
First submitted
21 Jul 2025
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [177Lu]Lu-PSMA-XT in people with mCRPC, run by Jinming Zhang at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jinming Zhang ((+86)010-66936108, Zhangjm301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1.Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Through study completion, assessed up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07096128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

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