Metastatic hormone-sensitive prostate cancer with high tumor load MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10071119 Term: Hormone-dependent prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: SHR3680
Product Code: SHR3680
Pharmaceutical Form: Tablet
INN or Proposed INN: n/a
CAS Number: 1572045-62-5
Current Sponsor code: SHR3680
Other descriptive name: SHR3680
Concentration un
Sponsors
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Age ?18 years, male; - Performance status ECOG scores 0-1; - Histologically or cytologically confirmed adenocarcinoma of the prostate, and no neuroendocrine differentiation or small cell features; - High tumor load, i.e., the radiological examination meets at least one of the following conditions: 1) ?4 bone metastatic foci are found in Tc-99m bone scan (at least one focus not in pelvis or spine); 2) visceral metastasis is shown in CT/MRI (not including lymph node); - Plan to receive or maintain ADT in study period, i.e., continuous use of luteinizing hormone releasing hormone analogue (LHRHA) (drug castration) or previous bilateral orchidectomy (surgical castration); - Being unable to tolerate or not willing to receive chemotherapy; - The organ function level must meet the following requirements: ANC?1.5×109/L; PLT?100×109/L; Hb?90 g/L; TBIL?1.5×ULN; ALT and AST ?2.5 × ULN; BUN(or UREC) and Cr?1.5×ULN; LVEF?50%. - Ability to comply with the study protocol as judged by the investigator; - Being voluntary to participate in this clinical trial, understanding the study procedure and being able to sign the written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 342 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 230
Exclusion criteria
Exclusion criteria: - Previous ADT, chemotherapy, surgery, external irradiation, brachytherapy, radiopharmaceutical or investigational local therapy (e.g., radiofrequency ablation, cryotherapy, high intensity focused ultrasound, etc.) for prostate cancer - Previous use or plan to use the second generation androgen receptor antagonist (e.g., enzalutamide, ARN-509, ODM-201), ketoconazole, Abiraterone Acetate or other drugs medicines uder development inhibiting synethsis of androgen (e.g., TAK-700) for treatment of prostate cancer during study treatment; - Having received the following therapies within 4 weeks prior to C1D1: ? 5a-reductase inhibitor (e.g., Finasteride, dutasteride); ? Estrogen, Progesterones, androgen, systemic steroids (except temporary use for anti-allergic purpuse); ? Plant medicine with known anti-prostate cancer or PSA-lowering effect (e.g., Saw Palmetto); ? Other study treatment in clinical trials. - Presence of radiologically confirmed central nervous system lesions; - Plan to receive any other antitumor therapies during this trial; - History of known allergy to the components of SHR3680 tablet or Bicalutamide tablet; - Inability to swallow, chronic diarrhea and intestinal obstruction, presence of multiple factors affecting drug intake and absorption; - History of epilepsy, or diseases that can induce epileptic seizure within 12 months prior to C1D1 (including history of transient ischemic attack, cerebral stroke, brain trauma with disturbance of consciousness requiring hospitalization); - Presence of active heart diseases within 6 months prior to C1D1, including severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure and ventricular arrhythmia requiring drug therapy; - Any other malignant tumor within 5 years prior to C1D1 (except carcinoma in situ that has been completely relieved and the malignant tumor that is judged by investigators as slowly progressive); - Active HBV, HCV infection (HBV virus?104copies/mL, HCVviru ?103copies/mL); - History of immunodeficiency (including positive HIV test, or having other acquired or congenital immunodeficiency disease) or history of organ transplantation; - Unwillingness to take effective contraceptive measures throughout the study treatment period and within 30 days after the last dose; - Presence of concomitant diseases (e.g., poorly controlled hypertension, serious diabetes, neurological or psychological disorders, etc.) or any other conditions that seriously endanger patient’s safety, may confuse the study results or affect completion of the study, according to investigator’s judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether SHR3680 combined with ADT is superior to Bicalutamide combined with ADT in improvement of rPFS and OS in subjects with high tumor load mHSPC.;Secondary Objective: - To evaluate and compare the time to PSA progression, time to the next bone related event, time to the start of the next anti-prostate cancer therapy and objective response rate in the subjects with high tumor load mHSPC who were treated with SHR3680 combined with ADT versus Bicalutamide combined with ADT - To evaluate and compare the safety of SHR3680 combined with ADT versus Bicalutamide combined with ADT in treatment of subjects with high tumor-load mHSPC.;Primary end point(s): rPFS, OS;Timepoint(s) of evaluation of this end point: When 282 events of radiological progression of disease occur, the primary endpoint rPFS will be analyzed. When 195 events of death occur, the interim analysis of the primary endpoint OS will be performed. When 325 events of death occur, the final analysis of the primary endpoint OS will be performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to PSA progression - Time to the next bone related event (including fracture, spinal compression, radiotherapy or surgery for bone) - Time to the start of the next anti-prostate cancer therapy - Objective response rate - Safety endpoint;Timepoint(s) of evaluation of this end point: - PSA evaluation: it will be performed within 7 days prior to the first dose, on Day 1 of each cycle from Cycle 2-12, once every two cycles from Cycle 13-36, once every 4 cycles afterwards; the first progression of PSA needs to be confirmed ?3 weeks later - Objective response rate: CT/MRI at baseline. If the evaluation first reaches the criteria of CR or PR, subjects must receive repeated test for confirmation 4 weeks after the first evaluation. - Bone related event, next anti-prostate cancer therapy, safety: throughout the study | — |
Countries
Bulgaria, China, Czechia, Czech Republic, Poland
Contacts
Public ContactFrank Becker
Jiangsu Hengrui Pharmaceuticals., Ltd.
Outcome results
None listed