PSMA PET-Positive Castration-Resistant Prostate CancerNCT06809426
Evaluating the Safety and Efficacy of 177Lu-LNC1011 Injection in a Single-Center, Single-Arm, Open Study in Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Desmoplasia-Resistant Prostate Cancer
A study testing 177Lu-LNC1011 in people with PSMA PET-Positive Castration-Resistant Prostate Cancer, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
Evaluating the safety and antitumor efficacy of 177Lu-LNC1011 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- PSMA PET-Positive Castration-Resistant Prostate Cancer
- What is being tested?
- 177Lu-LNC1011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2023to 24 Oct 2024
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old, male.
- histologically or cytologically defined prostate cancer, the patients have not been treated or have exhausted all treatment.
- meet the Prostate Cancer Working Group 3 (PCWG3) diagnosis of metastatic desmoplasia-resistant prostate cancer (mCRPC), including: a) the presence of a desmoplasia level of serum testosterone (serum testosterone <50 ng/dL or 1.7 nmol/L); b) and the presence of one of the following: - serum PSA progression: PSA >1 ng/mL and 2 consecutive rises in PSA 1 week apart, 2 greater than 50% of the nadir; or a bone scan suggestive of ≥2 new bone lesions; or CT or MRI suggestive of progression of soft tissue lesions (RECIST 1.1).
- a physical status score of ≤2 according to Eastern Cooperative Oncology Group (ECOG) criteria.
- PSMA positivity confirmed by 68Ga -PSMA PET/CT.
Who cannot join
- Patients who did not meet the requirements as assessed by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluating the safety and antitumor efficacy of 177Lu-LNC1011
Read the detailed description
This is a prospective, single-center, single-arm, open IIT clinical study evaluating the safety and anti-tumor efficacy of 177Lu-LNC1011 Injection in patients with PSMA-positive metastatic desmoplasia-resistant prostate cancer (mCRPC). Thirteen patients are expected to be enrolled. Subjects will be required to sign an informed consent form prior to screening, and successful screened subjects will be treated with 177Lu-LNC1011 Injection as 75 mCi (2.78 GBq) intravenously every 6 weeks for a total of no more than 6 doses during the treatment period. Subjects will be monitored for safety and anti-tumor efficacy after dosing during the treatment period.
- Being tested
- 177Lu-LNC1011
- Keywords
- PSMA, mCRPC, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-LNC1011Drug
75 mCi (2.78 GBq) of 177Lu-LNC1011 Injection intravenously each time, injections every 6 weeks, not to exceed a total of 6 injections.
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-LNC1011 | Experimental | Successfully screened subjects will be treated with 177Lu-LNC1011 Injection during the treatment period with 75 mCi (2.78 GBq) intravenously every 6 weeks for a total of no more than 6 doses. Subjects will be monitored for safety and anti-tumor efficacy after dosing during the treatment period. Receives: Drug: 177Lu-LNC1011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the difference in PSA changes before and after receiving 177Lu-LNC1011 treatment
Measured: 2-12 weeks
Objective remission rates in mCRPC patients as assess by RECIST V1.1 treated with 177Lu-LNC1011
Measured: 2-12 weeks
Secondary outcomes (2)
The radiation dose of 177Lu-LNC1011 in normal organs and tumors as assess by OLINDA/EXM
Measured: 1 day
The change of SUV (SUVmax, SUVmean) in 68Ga-PSMA PET/CT imaging before and after receiving 177Lu-LNC1011 treatment as assess by PMOD version 4.3
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start21 Aug 2023
- Primary completion14 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PSMA PET-Positive Castration-Resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjing Yu, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809426
- Sponsor's protocol ID
- LS2023057
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hou L, Wang Y, Fu H, Chen L, Yu C, Chen X, Zhang J. PSMA-targeted radioligand therapy with [177Lu]Lu-LNC1011 for metastatic castration-resistant prostate cancer: a pilot study. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4033-4043. doi: 10.1007/s00259-025-07245-8. Epub 2025 Apr 10.
PubMed 40208314
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of 177Lu-LNC1011 Injection in a Single-Center, Single-Arm, Open Study in Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Desmoplasia-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06809426
- Acronym / sponsor ID
- LS2023057
- Keywords
- PSMA, mCRPC, prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the safety and antitumor efficacy of 177Lu-LNC1011
Detailed description
This is a prospective, single-center, single-arm, open IIT clinical study evaluating the safety and anti-tumor efficacy of 177Lu-LNC1011 Injection in patients with PSMA-positive metastatic desmoplasia-resistant prostate cancer (mCRPC). Thirteen patients are expected to be enrolled. Subjects will be required to sign an informed consent form prior to screening, and successful screened subjects will be treated with 177Lu-LNC1011 Injection as 75 mCi (2.78 GBq) intravenously every 6 weeks for a total of no more than 6 doses during the treatment period. Subjects will be monitored for safety and anti-tumor efficacy after dosing during the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 177Lu-LNC1011 | Experimental | Drug: 177Lu-LNC1011Successfully screened subjects will be treated with 177Lu-LNC1011 Injection during the treatment period with 75 mCi (2.78 GBq) intravenously every 6 weeks for a total of no more than 6 doses. Subjects will be monitored for safety and anti-tumor efficacy after dosing during the treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old, male.
- histologically or cytologically defined prostate cancer, the patients have not been treated or have exhausted all treatment.
- meet the Prostate Cancer Working Group 3 (PCWG3) diagnosis of metastatic desmoplasia-resistant prostate cancer (mCRPC), including: a) the presence of a desmoplasia level of serum testosterone (serum testosterone <50 ng/dL or 1.7 nmol/L); b) and the presence of one of the following: - serum PSA progression: PSA >1 ng/mL and 2 consecutive rises in PSA 1 week apart, 2 greater than 50% of the nadir; or a bone scan suggestive of ≥2 new bone lesions; or CT or MRI suggestive of progression of soft tissue lesions (RECIST 1.1).
- a physical status score of ≤2 according to Eastern Cooperative Oncology Group (ECOG) criteria.
- PSMA positivity confirmed by 68Ga -PSMA PET/CT.
Key exclusion criteria (1 listed)
- Patients who did not meet the requirements as assessed by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-LNC101175 mCi (2.78 GBq) of 177Lu-LNC1011 Injection intravenously each time, injections every 6 weeks, not to exceed a total of 6 injections. | Drug | 177Lu-LNC1011 |
Primary outcome
To assess the difference in PSA changes before and after receiving 177Lu-LNC1011 treatment
Time frame: 2-12 weeks
Objective remission rates in mCRPC patients as assess by RECIST V1.1 treated with 177Lu-LNC1011
Time frame: 2-12 weeks
2 secondary outcomes
The radiation dose of 177Lu-LNC1011 in normal organs and tumors as assess by OLINDA/EXM
Time frame: 1 day
The change of SUV (SUVmax, SUVmean) in 68Ga-PSMA PET/CT imaging before and after receiving 177Lu-LNC1011 treatment as assess by PMOD version 4.3
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 40208314Hou L, Wang Y, Fu H, Chen L, Yu C, Chen X, Zhang J. PSMA-targeted radioligand therapy with [177Lu]Lu-LNC1011 for metastatic castration-resistant prostate cancer: a pilot study. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4033-4043. doi: 10.1007/s00259-025-07245-8. Epub 2025 Apr 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 177Lu-LNC1011 in people with PSMA PET-Positive Castration-Resistant Prostate Cancer, run by Affiliated Hospital of Jiangnan 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 5 inclusion and 1 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 5 Feb 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.
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?
To assess the difference in PSA changes before and after receiving 177Lu-LNC1011 treatment (time frame: 2-12 weeks). 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 NCT06809426, which also lists 1 linked publication.
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 5 Feb 2025.