Study of 177Lu-PSMA-0057 in Metastatic Prostate Cancer

NCT06050239 | Unknown Early Phase 1

• 1 other identifier: KY20221124-06
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of 177Lu-PSMA-0057 in metastatic prostate cancer.

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PSA dynamic

  PSA50 response rate, PSA90 response rate: PSA response determined by measuring a decrease of ≥ 50% or ≥ 90% in PSA levels from baseline to baseline, and reassessed at least 3 weeks later. The proportion of patients with a decrease of ≥ 50% or 90% in PSA response rate at a certain time point is usually used as an evaluation indicator. PSA undetectable rate: refers to the percentage of patients with PSA detectable at baseline (≥ 0.2ng/mL) but undetectable during the study period (\<0.2 ng/mL).

  2 weeks

Secondary Outcomes (1)

• Radiographic Progression Free Survival，rPFS

  12 weeks

Study Arms (1)

Radioligand Therapy

EXPERIMENTAL

The enrolled subjects will be administrated with 177Lu-PSMA-0057, and then enter the post administration observation phase while completing safety checks.

Drug: 177Lu-PSMA-0057

Interventions

177Lu-PSMA-0057 DRUG

The enrolled subjects will be administrated with 177Lu-PSMA-0057, and then enter the post administration observation phase while completing safety checks.

Radioligand Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, age\>18 years old;
• The expected life must be\>9 months (determined by the researcher);
• Eastern Cooperative Oncology Group(ECOG) score 0-2 points;
• Suffering from prostate adenocarcinoma confirmed by histological or cytological examination (current or previous prostate and/or metastatic site biopsy);
• Patients with high PSMA uptake (standardized uptake value (SUV) max ≥ salivary gland or proximal small intestine, or SUVmax ≥ 12) at the lesion site displayed on 68Ga-PSMA-0057 positron emission tomography / computer tomography(PET/CT) scan, and without FDG positive but PSMA negative lesions;
• There are diagnostic documents confirming metastatic prostate cancer;
• The patient must have ≥ 1 detectable metastatic lesion in the bone and/or soft tissue/visceral area, which is present on baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to the start of study treatment;
• Lymphatic and skeletal metastases or visceral metastases that cannot be removed through surgery;
• After ADT treatment, the disease continues to progress;
• The patient must have recovered to ≤ 2 levels from all clinically significant toxicity associated with previous treatments (i.e. chemotherapy, radiotherapy, immunotherapy, etc.);
• The functions of important organs meet the following requirements:
• Bone marrow reserve: White blood cell (WBC) count ≥ 2.5 × 10 \^ 9/L or absolute neutrophil count (ANC) ≥ 1.5 x 10 \^ 9/L; Platelet count ≥ 100 x 10 \^ 9/L; Hemoglobin ≥ 90g/L.
• Liver: Total bilirubin ≤ 2 times the upper limit of normal value (ULN) (excluding subjects confirmed to have Gilbert's disease, no more than 10 times the ULN is sufficient); AST and ALT: ≤ 2 times ULN for those without liver metastasis or ≤ 3 times ULN for those with liver metastasis.
• Kidney: Serum/plasma creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 50 mL/min.
• Albumin\>25 g/L;

You may not qualify if:

• Received radioisotope diagnosis or treatment (such as 89Sr, 153Sm, 186Re, 188Re, 223Ra) before enrollment, or received PSMA targeted radioligand therapy;
• Received systemic anti prostate cancer treatment such as chemotherapy, PARP inhibitors, immunotherapy or biotherapy (including monoclonal antibodies) within 28 days prior to enrollment;
• Received any other study drug diagnosis/treatment within 28 days prior to enrollment, unless it is an observational (non intervention) clinical study or an intervention clinical study follow-up;
• Other accompanying cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy;
• Known to be allergic to any research treatment or its excipients, or to drugs of similar chemical categories;
• Unable to lie flat, remain stationary, or tolerate PET/CT imaging;
• Severe urinary incontinence, hydronephrosis, severe urinary dysfunction, or the need for indwelling a catheter for any reason;
• There are contraindications to furosemide, including known allergies or intolerance to furosemide or sulfonamide drugs;
• Patients with central nervous system (CNS) metastasis accompanied by neurological instability or symptoms or receiving corticosteroids to maintain neurological integrity. If epidural diseases, spinal canal diseases, and previously affected areas of the spinal cord have been treated, stabilized, and have no neurological damage, they are eligible to participate in the study. For patients with a history of CNS metastasis to the brain parenchyma (or CNS metastasis), baseline and subsequent radiological imaging must include brain evaluation (preferably magnetic resonance imaging (MRI) or enhanced CT); Note: Patients with a history of CNS metastasis who have previously received treatment, have stable neurological function, are asymptomatic, and have not received corticosteroid treatment are allowed to be included in the group.
• Diagnosed as other malignant tumors that are expected to change life expectancy or may interfere with disease assessment. However, patients with a past history of malignant tumors, who have been fully treated and have no disease for more than 3 years are eligible to participate in the study, and patients with fully treated non melanoma skin cancer and superficial bladder cancer are also eligible to participate in the study;
• The presence of clinically significant active heart disease is defined as any of the following:
• Within 6 months before signing the ICF, New York Heart Association(NYHA) grade 3/4 congestive heart failure, unless improved after treatment, and if the echocardiogram shows ejection fraction(EF) \>45%, the symptoms improve to\<grade 3; Previous or current diagnosis of ECG abnormalities indicates significant safety risks for study participants, such as accompanying clinically significant arrhythmias such as persistent ventricular tachycardia, complete left bundle branch block, and high degree atrioventricular (AV) block (such as double bundle branch block, Mobitz II type, and third degree atrioventricular block); A family history of familial long QT syndrome or known family history of torsade de pointe ventricular tachycardia; Cardiac abnormalities or cardiac repolarization abnormalities, including any of the following: a history of myocardial infarction (MI), angina pectoris, or coronary artery bypass grafting (CABG) within 6 months prior to signing the ICF.
• Complicated with any serious and/or uncontrollable diseases or other diseases that may affect the subject's participation in this study as determined by the investigator, as follows: Uncontrolled diseases (such as hypertension patients' blood pressure ≥ 150/100 mmHg or diabetes patients' fasting blood glucose ≥ 8mmol/L or 2h after meal blood glucose ≥ 11mmol/L); Life threatening autoimmune and ischemic diseases; Suffering from any other disease that may increase the risk of toxic reactions (such as nephrotic syndrome, uremia, acute or severe cholinergic syndrome, etc.); Clinically severe gastrointestinal dysfunction, including active ulcerative colitis, intestinal obstruction, intestinal bleeding, diarrhea, Crohn's disease, or the need for intravenous nutrition treatment;
• The disease progresses rapidly and the expected survival period is less than or equal to 3 months;
• Known to have bilateral hip joint prostheses;

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Feng Wang

  Nanjing First Hospital, Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Feng Wang

CONTACT

02552271491; fengwangcn@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: September 22, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

CN (1)