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Clinical Trials in China / NCT06350825
Recruiting Phase 3

Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients

NCT06350825 · tracked via the Priya Life Science China tracker
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Phase
Phase 3
Started
2016-01-01
Last updated
2024-04-05

Condition(s) studied

Metastatic Prostate CancerTherapy, Directly Observed

Investigational drug(s) / intervention(s)

Cytoreductive prostatectomy or brachytherapyADT+second-generation antiandrogens ± chemotherapy

Cytoreductive prostatectomy or brachytherapy: local treatment+SOC for metastatic prostate cancer

ADT+second-generation antiandrogens ± chemotherapy: SOC(Triplet or doublet therapy) for mHSPC

Study summary

To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)

Eligibility

Sex
MALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male aged ≥18 and ≤75; 2. Histologically confirmed prostate adenocarcinoma; 3. Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology; 4. Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis); 5. Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.); 6. The surgeon believes the prostate can be removed; Exclusion Criteria: 1. The surgeon believes the disease is unresectable; 2. Life expectancy less than 2 years; 3. Active spinal cord compression; 4. History of prior local treatment for prostate cancer; 5. Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption; 6. Refusal to sign the informed consent; 7. Investigator believes the individual is not suitable for inclusion.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu Recruiting

More The First Affiliated Hospital with Nanjing Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06350825 on ClinicalTrials.gov ↗ ← All trials in China