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Metastatic Castration-resistant Prostate Cancer, mCRPCPhase 1NCT06377683

Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 1 study testing 177Lu-Dansyl-PSMA radioligand therapy in people with Metastatic Castration-resistant Prostate Cancer, mCRPC, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Ten to 20% of patients with prostate cancer (PC) experience progression in their disease, even after undergoing pharmaceutical or surgical castration, leading to metastatic CRPC (mCRPC). Prostate-specific membrane antigen (PSMA) is a membrane-bound glycoprotein mostly specific to the prostate. Read more about this study

Who is it for?
Ages 21 years and older, men only
What is being tested?
177Lu-Dansyl-PSMA radioligand therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChina
Study dates
5 Apr 2024to 27 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

Who may be able to join

  • Ability to understand and willingness to sign a written informed consent document.
  • Age 21 and older
  • Confirmed unresectable PC that is refractory to or has progressed following prior treatments.
  • Confirmed unresectable PC with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis)
  • Patients must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
  • Eastern Cooperative Oncology Group Performance Status ≤ 3
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  • Participant must have completed prior therapy at least 2 weeks (washout period) before 68Ga-PSMA PET/CT scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved below Grade 2 or baseline. Completion of entry into 68Ga-PSMA study and completion of the scan
  • Patients must be 68Ga-PSMA PET/CT scan positive.
  • Hematologic parameters defined as:
  • Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL
  • Blood chemistry levels defined as:
  • AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 3 times ULN Creatinine ≤ 3 times ULN Able to remain motionless for up to 30-60 minutes per scan

Who cannot join

  • Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)
  • Participants with Class 3 or 4 NYHA Congestive Heart Failure
  • Clinically significant bleeding within two weeks before trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
  • Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days before study day 1 or anticipated surgery within the subsequent 6 weeks
  • Has an additional active malignancy requiring therapy within the past 2 years
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
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  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • Cannot undergo PET/CT scanning because of weight limits (350 lbs)
  • INR>1.2; PTT>5 seconds above UNL

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

Other trials in China

About this study

Official title: An Open-Label, Non-Randomized, Single-Center, Investigator-Initiated Trial to Determine the Safety, Dosimetry, and Preliminary Effectiveness of 177Lu-Dansyl-PSMA in Patients With Metastatic Castration-Resistant Prostate Cancer

Ten to 20% of patients with prostate cancer (PC) experience progression in their disease, even after undergoing pharmaceutical or surgical castration, leading to metastatic CRPC (mCRPC). Prostate-specific membrane antigen (PSMA) is a membrane-bound glycoprotein mostly specific to the prostate. While PSMA is expressed at low levels in normal prostate, this expression increased by 100-1000-fold in PC, which makes it a favorable target for therapy. This study was designed to evaluate the safety, tolerability, and maximum tolerated dose of a long-lasting radiolabeled ligand 177Lu-Dansyl-PSMA in mCRPC patients.

Read the detailed description

This proposal is a phase I, open-label study of escalating doses of 177Lu-Dansyl-PSMA Injection in patients with PSMA-positive mCRPC. The initial dose of 177Lu-Dansyl-PSMA is 1.85GBq (50 mCi), and subsequent cohorts receive an incremental 50% dose increase until dose-limiting toxicity (DLT) is observed. Treatment is planned for up to 2 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed the safety and maximum tolerated dose of 177Lu-Dansyl-PSMA used for radioligand therapy in patients with PSMA-positive mCRPC. Secondary endpoints included dosimetry and determination of the preliminary treatment efficacy of 177Lu-Dansyl-PSMA.

Being tested
177Lu-Dansyl-PSMA radioligand therapy
Keywords
mCRPC, radioligand therapy, PSMA, 177Lu-DansyI-PSMA

What participants receive

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

  • 177Lu-Dansyl-PSMA radioligand therapyDrug

    Radioligand therapy using 177Lu-Dansyl-PSMA 50mCi (1.85GBq) will performed 6-weekly. A maximum of 2 cycles will be administered, and subsequent cohorts receive an incremental 50% dose increase until dose-limiting toxicity (DLT) was observed.

Study groups in NCT06377683
Study groupRoleWhat they receive
177Lu-Dansyl-PSMAExperimental177Lu-Dansyl-PSMA A maximum of 2 cycles of 50 mCi (1.85 GBq) 177Lu-Dansyl-PSMA, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 2 cycles, every 6 weeks. Subsequent cohorts received an incremental 50% dose increase until dose-limiting toxicity (DLT) was observed.
Receives: Drug: 177Lu-Dansyl-PSMA radioligand therapy

What is being measured

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

  1. Incidence of treatment-related adverse events (safety and tolerability)

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Dose-limiting toxicity was defined as any 177Lu-Dansyl-PSMA-related AE ≥ grade 3 (G3).

    Measured: At the end of Cycle 2 (each cycle is 42 days)

  2. To determine the maximum tolerated dose (MTD)

    The MTD is the dose level below that which 2 out of 6 subjects in a cohort have DLT

    Measured: At the end of Cycle 2 (each cycle is 42 days)

Secondary outcomes (1)

  1. Dosimetry

    Dosimetry, measured as absorbed dose in tumor and normal organs (Gy/GBq), was estimated in the first treatment cycle for each patient.

    Measured: At the end of Cycle 1 (each cycle is 42 days)

Timeline

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

  1. First posted22 Apr 2024
  2. Study start5 Apr 2024
  3. Primary completion27 Mar 2025
  4. Study completion27 Mar 2025

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
Model description
classic 3+3 dose escalation
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06377683
Sponsor's protocol ID
XMYY-2023KY122
Status last verified
Mar 2025
First submitted
17 Apr 2024
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 177Lu-Dansyl-PSMA radioligand therapy in people with Metastatic Castration-resistant Prostate Cancer, mCRPC, run by The First Affiliated Hospital of Xiamen University at 1 site 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 12 inclusion and 9 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: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related adverse events (safety and tolerability) (time frame: At the end of Cycle 2 (each cycle is 42 days)). The study lists 2 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 NCT06377683.

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 1 Apr 2025.

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