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Trial Title:
Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients
NCT ID:
NCT06350825
Condition:
Metastatic Prostate Cancer
Therapy, Directly Observed
Conditions: Official terms:
Prostatic Neoplasms
Androgen Antagonists
Conditions: Keywords:
prostate cancer
cytoreductive prostatectomy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
randomized control
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Cytoreductive prostatectomy or brachytherapy
Description:
local treatment+SOC for metastatic prostate cancer
Arm group label:
Local treatment group
Other name:
surgery or radiation therapy+SOC
Intervention type:
Drug
Intervention name:
ADT+second-generation antiandrogens ± chemotherapy
Description:
SOC(Triplet or doublet therapy) for mHSPC
Arm group label:
SOC group
Other name:
hormonal therapy or chemotherapy
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)
Detailed description:
To investigate the multimodality approaches for mHSPC
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Shangqian Wang, M.D.
Phone:
13770561625
Email:
wsq5501@126.com
Investigator:
Last name:
Lixin Hua, M.D.
Email:
Principal Investigator
Start date:
January 1, 2016
Completion date:
December 31, 2028
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06350825
