CompletedNot Applicable

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

China13 participantsStarted 2023-08-21

Plain-language summary

Evaluating the safety and antitumor efficacy of 177Lu-LNC1011

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ≥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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the difference in PSA changes before and after receiving 177Lu-LNC1011 treatment

Timeframe: 2-12 weeks

Objective remission rates in mCRPC patients as assess by RECIST V1.1 treated with 177Lu-LNC1011

Timeframe: 2-12 weeks

Trial details

NCT IDNCT06809426

SponsorAffiliated Hospital of Jiangnan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-14

View on ClinicalTrials.gov More PSMA PET-Positive Castration-Resistant Prostate Cancer trials