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

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

Recruiting
18-75 years
Male
Phase 3

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Overview

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)

Description

To investigate the multimodality approaches for mHSPC

Eligibility

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.

Study details
    Metastatic Prostate Cancer
    Therapy
    Directly Observed

NCT06350825

The First Affiliated Hospital with Nanjing Medical University

14 April 2024

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