NCT06377683CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 17 Apr 2024
- Start date
- Apr 2024
- Primary completion date
- Mar 2025
- Lead sponsor
- The First Affiliated Hospital of Xiamen University
- Diseases
- Prostate cancer
- NCT number
- NCT06377683
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 8
- From Apr 2024 to the primary completion date, Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Participants with Class 3 or 4 NYHA Congestive Heart Failure
- Has an additional active malignancy requiring therapy within the past 2 years
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Psychiatric illness/social situations that would interfere with compliance with study requirements
Lab values
- INR\>1.2; PTT\>5 seconds above UNL
Other
- Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)
- Cannot undergo PET/CT scanning because of weight limits (350 lbs)
Who the study is looking for
- 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
- 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
Age in the registry: 21 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.