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

Metastatic Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350825
• Other study ID #: 2023-SR-543
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2016
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Lixin Hua, M.D.
• Phone: 13072564303
• Email: hlx5858[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

To investigate the multimodality approaches for mHSPC

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

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.

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rPFS	Assess how long a cancer patient lives without any signs of progression of their disease, as determined by radiographic evidence	3 year
Secondary	Safety of CRP in mHSPC patients	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	until one year after the local therapy