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

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

NCT06377683•The First Affiliated Hospital of Xiamen University

View on ClinicalTrials.gov

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. 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.

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.

Eligibility

Age

21 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Ability to understand and willingness to sign a written informed consent document.
•2. Age 21 and older
•3. Confirmed unresectable PC that is refractory to or has progressed following prior treatments.
•4. 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)
•5. Patients must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
•6. Eastern Cooperative Oncology Group Performance Status ≤ 3
•7. 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
•8. Patients must be 68Ga-PSMA PET/CT scan positive.
•9. Hematologic parameters defined as:
•Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL
+2 more criteria

Exclusion Criteria

•1. Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)
•2. Participants with Class 3 or 4 NYHA Congestive Heart Failure
•3. Clinically significant bleeding within two weeks before trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
•4. 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
•5. Has an additional active malignancy requiring therapy within the past 2 years
•6. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
•7. Psychiatric illness/social situations that would interfere with compliance with study requirements
•8. Cannot undergo PET/CT scanning because of weight limits (350 lbs)
•9. INR\>1.2; PTT\>5 seconds above UNL

Locations (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Key Dates

Start Date

April 5, 2024

Primary Completion Date

March 27, 2025

Completion Date

March 27, 2025

Last Updated

April 1, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Castration-resistant Prostate Cancer, mCRPC

Interventions

177Lu-Dansyl-PSMA radioligand therapy

DRUG

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

NCT07103018

Metastatic Castration-resistant Prostate CancerMetastatic Castration-Resistant Prostate Cancer Patients+3 more

View study

ACTIVE_NOT_RECRUITINGPHASE2

[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2

NCT05579184

Metastatic Castration-resistant Prostate Cancer, mCRPC

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application_2

Study on the Safety, Tolerability, and Preliminary Efficacy of 161Tb-NYM032 in Patients with Metastatic Castration-Resistant Prostate Cancer