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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06350825
Other study ID # 2023-SR-543
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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