Tests SHR3680 with hormone therapy in men with advanced prostate cancer
Compares SHR3680 plus hormone therapy with bicalutamide in advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: A clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of prostate cancer
Key facts
- Where
- Brno-Stred, Olomouc, and Prague 5, CzechiaSee the 3 sites
- Phase
- Phase 3
Where in Czechia
- Fakultni Nemocnice U Sv Anny V BrneBrno-Stred, CzechiaTaking people
- University Hospital OlomoucOlomouc, CzechiaTaking people
- Nemocnice Na HomolcePrague 5, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Hengrui Pharmaceuticals Co. Ltd.
- Trial code
- NCT03520478EU 2024-515194-10-00
- Record updated
- 17 August 2026
- Original description
To determine whether SHR3680 combined with ADT is superior to Bicalutamide combined with ADT in terms of improving the radiological progression-free survival (rPFS) and overall survival (OS) in mHSPC subjects with high tumor load.Read full original descriptionShow less
One multicenter, randomized, open, phase III clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of metastatic hormone-sensitive prostate cancer with high tumor load.
To determine whether SHR3680 combined with ADT is superior to Bicalutamide combined with ADT in terms of improving the radiological progression-free survival (rPFS) and overall survival (OS) in mHSPC subjects with high tumor load.
Inclusion: 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 characteristics indicated; 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); 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: Previous ADT, chemotherapy, surgery, external irradiation, brachytherapy, radiopharmaceuticals or experimental local treatment (including radiofrequency ablation, cryotherapy, high intensity focused ultrasound, etc.), with some exceptions; 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; 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; Plan to receive any other antitumor therapies during this trial; Presence of tumor lesion in central nervous system through radiologically confirmed diagnosis.