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A clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of prostate cancer
EU CTIS ID: 2024-515194-10-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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);
You likely can't join if
- 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.
- Presence of tumor lesion in central nervous system through radiologically confirmed diagnosis.
- Plan to receive any other antitumor therapies during this trial.
The study team makes the final eligibility decision.
Where it's taking place
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.