CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer
Systemic Therapy Combined With Cytoreductive Prostatectomy for the Treatment of de Novo Poly-metastatic Hormone Sensitive Prostate Cancer: A Prospective, Open-label Randomized Controlled Trial
About This Trial
The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC). The main questions it aims to answer are: 1. To explore the clinical benefit and safety of systemic therapy combined with cytoreductive prostatectomy for patients with de novo pmHSPC. 2. To explore the characteristics of the subgroup of patients who could benefit more from the above treatment. 3. To explore the relationship between stage efficacy and clinical prognosis. 4. To explore the correlation between molecular imaging such as PSMA-PET/CT and its changes with treatment efficacy. Participants will undergo systemic therapy combined with cytoreductive prostatectomy. Researchers will compare systemic therapy combined with cytoreductive prostatectomy with SOC to see the pros and cons of the two strategies.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Systemic Chemohormonal Therapy
Under continuous ADT, docetaxel 75mg/m\^2 body surface area every 21 days, oral dexamethasone 7.5mg pretreatment 12h, 3h, 1h before each infusion of docetaxel, and a total of 10mg of prednisolone per day when needed according to the decision of the researcher (in the case of grade 3 and above neutropenia or peripheral edema); oral darolutamide 600mg twice per day, 21 days for one cycle, six cycles in total.
Systemic Hormonal Therapy
Under continuous ADT, oral darolutamide 600mg twice per day
Cytoreductive Prostatectomy
Cytoreductive prostatectomy was performed after six cycles of neoadjuvant systemic chemohormonal therapy.
Postoperative Adjuvant Radiotherapy
Postoperative adjuvant radiotherapy of prostate bed is performed, if margin positive, with conventional segmentation and the dose of 64-72Gy.