PSMA PET-Positive Castration-Resistant Prostate Cancer
Conditions
Keywords
PSMA, mCRPC, prostate cancer
Brief summary
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.
Interventions
DRUG177Lu-LNC1011
75 mCi (2.78 GBq) of 177Lu-LNC1011 Injection intravenously each time, injections every 6 weeks, not to exceed a total of 6 injections.
Sponsors
Affiliated Hospital of Jiangnan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old, male. 2. histologically or cytologically defined prostate cancer, the patients have not been treated or have exhausted all treatment. 3. 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). 4. a physical status score of ≤2 according to Eastern Cooperative Oncology Group (ECOG) criteria. 5. PSMA positivity confirmed by 68Ga -PSMA PET/CT.
Exclusion criteria
Patients who did not meet the requirements as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the difference in PSA changes before and after receiving 177Lu-LNC1011 treatment | 2-12 weeks |
| Objective remission rates in mCRPC patients as assess by RECIST V1.1 treated with 177Lu-LNC1011 | 2-12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The radiation dose of 177Lu-LNC1011 in normal organs and tumors as assess by OLINDA/EXM | 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 | 1 day |
Countries
China
Outcome results
None listed