CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer

NARecruitingINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

March 21, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Prostate Cancer
Interventions
DRUG

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.

DRUG

Systemic Hormonal Therapy

Under continuous ADT, oral darolutamide 600mg twice per day

PROCEDURE

Cytoreductive Prostatectomy

Cytoreductive prostatectomy was performed after six cycles of neoadjuvant systemic chemohormonal therapy.

PROCEDURE

Postoperative Adjuvant Radiotherapy

Postoperative adjuvant radiotherapy of prostate bed is performed, if margin positive, with conventional segmentation and the dose of 64-72Gy.

Trial Locations (1)

200127

RECRUITING

Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
lead

RenJi Hospital

OTHER