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

NCT06350825 | Recruiting Phase 3

• 1 other identifier: 2023-SR-543
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Metastatic Prostate Cancer; Therapy, Directly Observed

Keywords

prostate cancer; cytoreductive prostatectomy

Outcome Measures

Primary Outcomes (1)

• rPFS

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

  3 year

Secondary Outcomes (1)

• Safety of CRP in mHSPC patients

  until one year after the local therapy

Study Arms (2)

Local treatment group

EXPERIMENTAL

Triplet or doublet therapy followed by cytoreductive prostatectomy or brachytherapy

Procedure: Cytoreductive prostatectomy or brachytherapy

SOC group

ACTIVE COMPARATOR

Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide)

Drug: ADT+second-generation antiandrogens ± chemotherapy

Interventions

Cytoreductive prostatectomy or brachytherapy PROCEDURE

local treatment+SOC for metastatic prostate cancer

Also known as: surgery or radiation therapy+SOC

Local treatment group

ADT+second-generation antiandrogens ± chemotherapy DRUG

SOC(Triplet or doublet therapy) for mHSPC

Also known as: hormonal therapy or chemotherapy

SOC group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Directly Observed Therapy

Interventions

Brachytherapy; Surgical Procedures, Operative; Drug Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Lixin Hua, M.D.

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lixin Hua, M.D.

CONTACT

13072564303; hlx5858@163.com

Shangqian Wang, M.D.,PhD

CONTACT

13770561625; wsq5501@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: randomized control

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 5, 2024
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)