REZVILUTAMIDE for Metastatic hormone-sensitive prostate cancer

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years, male\n- Performance status ECOG Scores 0-1;\n- Histologically or cytologically confirmed adenocarcinoma of the prostate, and no neuroendocrine differentiation or small cell characteristics indicated;\n- High tumor load, i.e., the radiological examination meets at least one of the following conditions: 1) ≧4 bone metastatic foci in Tc-99m bone scanning (at least one focus not located in pelvis or spine); 2) visceral metastasis shown on CT/MRI (not including lymph nodes);\n- Plan to receive or maintain ADT during the study, i.e., to receive luteinizing hormone releasing hormone analogue (LHRHA) for continuous treatment (medical castration) or previous bilateral orchidectomy (surgical castration);"}

Exclusion criteria

• {"criterion_text":"- Previous ADT, chemotherapy, surgery, external irradiation, brachytherapy, radiopharmaceuticals or experimental local treatment (including radiofrequency ablation, cryotherapy, high intensity focused ultrasound, etc.), with some exceptions.\n- Previous use or plan to use the 2nd generation androgen receptor antagonist (e.g., enzalutamide, ARN-509, ODM-201), ketoconazole, Abiraterone Acetate or other drugs under development inhibiting androgen synthesis (e.g., TAK-700) during study treatment for treatment of prostate cancer.\n- The subjects have received the following therapies within 4 weeks prior to C1D1:  5α-reductase inhibitor (e.g., Finasteride, dutasteride, etc.);  Estrogen, progesterone, androgen, steroid systemic therapy (except the temporary use for anti-allergic purpose);  Plant medicine with known anti-prostate cancer or PSA-lowering effect (e.g., Saw Palmetto);  Study treatment in other clinical trials.\n- Presence of tumor lesion in central nervous system through radiologically confirmed diagnosis.\n- Plan to receive any other antitumor therapies during this trial."}

Primary endpoints

• {"endpoint_text":"- rPFS,OS","definition_or_measurement_approach":"rPFS = radiological progression-free survival (radiologically confirmed progression); OS = overall survival (overall survival as stated in main objective)."}

Secondary endpoints

• {"endpoint_text":"- Time to PSA progression.\n- Time to the next bone related event (including fracture, spinal compression, radiotherapy or surgery for bones).\n- Time to the start of the next anti-prostate cancer treatment.\n- ORR\n- Safety endpoint.","definition_or_measurement_approach":"Time to PSA progression: time until PSA-defined progression. Time to next bone related event: time until events such as fracture, spinal compression, radiotherapy or surgery for bones. Time to start of next anti-prostate cancer treatment: time until initiation of next systemic anti-prostate cancer therapy. ORR: objective response rate. Safety endpoint: assessment of safety/tolerability as reported."}

Poland

Latest Decision Or Authorization Date

09-12-2024

Number Of Sites

1

Number Of Participants

11

Czechia

Latest Decision Or Authorization Date

26-11-2024

Number Of Sites

3

Number Of Participants

23

Bulgaria

Latest Decision Or Authorization Date

03-12-2024

Number Of Sites

4

Number Of Participants

29

Primary sponsor

Full Name

Jiangsu Hengrui Pharmaceuticals Co. Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

China