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RECRUITING
NCT06306612
NA

CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2024-03-21

Completion Date

2028-12-31

Last Updated

2025-03-05

Healthy Volunteers

No

Conditions

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.

Locations (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China