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NCT Number: NCT06350825

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

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)

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Key information

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location status: Recruiting

Location contact

Lixin Hua, M.D.

PRINCIPAL_INVESTIGATOR

Shangqian Wang, M.D.

CONTACT

[email protected]

13770561625

About this study

To investigate the multimodality approaches for mHSPC

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male aged ≥18 and ≤75;
  • Histologically confirmed prostate adenocarcinoma;
  • Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology;
  • Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis);
  • Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.);
  • The surgeon believes the prostate can be removed;

Exclusion criteria

  • The surgeon believes the disease is unresectable;
  • Life expectancy less than 2 years;
  • Active spinal cord compression;
  • History of prior local treatment for prostate cancer;
  • Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption;
  • Refusal to sign the informed consent;
  • Investigator believes the individual is not suitable for inclusion.

Treatment and study plan

Cytoreductive prostatectomy or brachytherapy

Procedure

local treatment+SOC for metastatic prostate cancer

Other names: surgery or radiation therapy+SOC

ADT+second-generation antiandrogens ± chemotherapy

Drug

SOC(Triplet or doublet therapy) for mHSPC

Other names: hormonal therapy or chemotherapy

Primary outcomes

  1. rPFS

    Time frame: 3 year

    Assess how long a cancer patient lives without any signs of progression of their disease, as determined by radiographic evidence

Secondary outcomes

  1. Safety of CRP in mHSPC patients

    Time frame: until one year after the local therapy

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Study contacts

Contact information is provided by the study sponsor or research team.

Lixin Hua, M.D.

CONTACT

[email protected]

13072564303

Shangqian Wang, M.D.,PhD

CONTACT

[email protected]

13770561625

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Evaluating the Efficacy and Safety of Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer

Important dates

Study start
2016
Primary completion
2027
Study completion
2028
First posted
Apr 5, 2024
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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