mCRPC
Conditions
Keywords
mCRPC
Brief summary
This is an open-label，prospective，single-arm，phase 2 trial aims to evaluate the efficacy and safety of disitamab vedotin combined with abiraterone in patients with metastatic castration-resistant prostate cancer.
Interventions
Disitamab Vedotin 2mg/kg is administered intravenously once every 2 weeks (1 cycle)
Abiraterone 1000mg is administered orally once a day，and prednisone 5mg is administered orally twice a day.
Sponsors
Nanjing University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Experimental regimen: Disitamab vedotin +Abiraterone +Prednisone
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients are able to understand and voluntarily sign the informed consent form (ICF); judged by the investigator to be capable of complying with the protocol. * Male patients of ≥18 years or older at the time of ICF signature. * Patients with ECOG performance status 0-1. * Patients with an expected survival of 3months or more. * Patients who are histologically or cytologically confirmed prostatic adenocarcinoma with HER2 expression (IHC 1+, 2+ or 3+) in archival or fresh tumour tissue. * Patients with documented castration-resistant prostate cancer (CRPC): serum testosterone \<1.73 nmol/L (50 ng/dL) at screening; patients on medical castration must continue LHRH agonist/antagonist therapy throughout the study. * Patients with evidence of metastatic disease by bone scan (bone lesions) and/or CT/MRI (soft-tissue lesions). * Patients with adequate organ function as defined below: * Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L * Platelet count (PLT) ≥100 × 10⁹/L * Hemoglobin (Hb) ≥100 g/L * Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); ≤2 × ULN if liver metastases present * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; ≤2 × ULN if liver metastases present * Serum creatinine (Cr) ≤1.5 × ULN or calculated creatinine clearance (CrCl) ≥60 mL/min (Cockcroft-Gault formula; calculate only if Cr \>1.5 × ULN) * Urinalysis protein \<2+; if ≥2+, 24-h urine protein must be \<1 g or urine protein/creatinine ratio \<0.5 * For patients not on anticoagulation: INR and aPTT ≤1.5 × ULN; patients on stable-dose anticoagulation are eligible * Left ventricular ejection fraction (LVEF) ≥50% or ≥local lower limit of normal (LLN), whichever is lower * QTcF interval \<470 ms * Male patients with partners of child-bearing potential must use a medically acceptable contraceptive method from the first study dose until 3 months after the last dose.
Exclusion criteria
* Patients who are known hypersensitivity to any component of disitamab vedotin or abiraterone. * Patients with other malignancies within 3 years before screening, except early-stage malignancies considered clinically cured (carcinoma in situ or stage I tumors), e.g., basal-cell or squamous-cell skin carcinoma or superficial bladder cancer. * Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with treated brain metastases may enroll if lesions have been stable for ≥1 month, there is no evidence of new or enlarging CNS disease, and systemic corticosteroids have been discontinued ≥3 days before the first study dose. * Patients who are clinically significant pericardial effusion, or pleural/peritoneal/pelvic effusions that are poorly controlled or require drainage within 2 weeks before the first dose. * Patients with major surgical intervention (any grade 3 or 4 procedure per the 2009 Chinese Regulation on Clinical Application of Medical Technologies) within 4 weeks before the first dose, or incomplete post-operative recovery that, in the investigator's judgment, poses a risk to trial participation. * Patients who are prior PSMA-targeted therapy. * Patients within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before the first dose: any antineoplastic chemotherapy (except castration therapy), radiotherapy (\>1 week of local palliative radiotherapy permitted), endocrine therapy (estrogens or anti-androgens; bicalutamide or nilutamide require 6-week washout), targeted therapy, immunotherapy, or participation in another interventional clinical trial (observational studies or post-trial follow-up are allowed). * Patients with stable-dose denosumab or bisphosphonates for bone metastases are permitted. * mCRPC patients must not have used PSA-lowering herbal agents (e.g., saw palmetto) or systemic corticosteroids (except short courses for allergy prophylaxis/treatment) within 4 weeks before the first dose, nor plan to use such agents during the study. * Patients with use of antineoplastic traditional Chinese medicine (TCM) prescriptions or proprietary TCM within 1 week, or receipt of blood transfusion/blood products, hematopoietic growth factors, or other agents to correct blood cell counts within 2 weeks before first study dose. * Patients with toxicities from prior antineoplastic therapy that have not resolved to baseline, CTCAE v5.0 grade 0-1 (except alopecia and pigmentation), or to the levels specified in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSA 50 | baseline up to 24 weeks | Proportion of patients with a ≥50 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA 30 | baseline up to 24 weeks | Proportion of patients with a ≥30 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later. |
| PSA 90 | baseline up to 24 weeks | Proportion of patients with a ≥90 % prostate-specific antigen (PSA) reduction from baseline at Week 12, confirmed by a repeat assessment at least 3 weeks later. |
| Radiographic Progression-Free Survival（rPFS） | From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months | Time from the first day of study drug administration to the earlier of radiographic progression or death from any cause. |
Countries
China
Contacts
Primary ContactHongqian Guo Hong qian Guo
Backup ContactShun Zhang Shun Zhang
Outcome results
None listed