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

March 29, 2024 updated by: Hua Lixin, The First Affiliated Hospital with Nanjing Medical University

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To investigate the multimodality approaches for mHSPC

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Shangqian Wang, M.D.,PhD
  • Phone Number: 13770561625
  • Email: wsq5501@126.com

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Lixin Hua, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Local treatment group
Triplet or doublet therapy followed by cytoreductive prostatectomy or brachytherapy
Procedure: Cytoreductive prostatectomy or brachytherapy
local treatment+SOC for metastatic prostate cancer
Other Names:
  • surgery or radiation therapy+SOC
Active Comparator: SOC group
Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide)
Drug: ADT+second-generation antiandrogens ± chemotherapy
SOC(Triplet or doublet therapy) for mHSPC
Other Names:
  • hormonal therapy or chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
until one year after the local therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Lixin Hua, M.D., The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-SR-543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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