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CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer

NCT06306612 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2025-03-05

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Yinjie Zhu, Dr. · RenJi Hospital

  • Liang Dong, Dr. · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06306612 on ClinicalTrials.gov