Actively Recruiting
CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer
Led by RenJi Hospital · Updated on 2025-03-05
192
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC). The main questions it aims to answer are: 1. To explore the clinical benefit and safety of systemic therapy combined with cytoreductive prostatectomy for patients with de novo pmHSPC. 2. To explore the characteristics of the subgroup of patients who could benefit more from the above treatment. 3. To explore the relationship between stage efficacy and clinical prognosis. 4. To explore the correlation between molecular imaging such as PSMA-PET/CT and its changes with treatment efficacy. Participants will undergo systemic therapy combined with cytoreductive prostatectomy. Researchers will compare systemic therapy combined with cytoreductive prostatectomy with SOC to see the pros and cons of the two strategies.
CONDITIONS
Official Title
CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 to 85 years
- Able to understand the study purpose and willing to sign informed consent
- Diagnosed with prostate adenocarcinoma confirmed by tissue or cell analysis
- Have five or more metastatic lesions above the aortic bifurcation as defined by RECIST v1.1
- Meet doctor’s recommendation for androgen deprivation therapy and docetaxel treatment
- Have not received any prior local or systemic treatment for prostate cancer
- Have an ECOG performance status of 0 or 1
- Blood counts at screening: hemoglobin ≥ 9.0 g/dL, neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L
- Liver and kidney function within specified normal limits
You will not qualify if you...
- Prior treatments for prostate cancer including hormone therapy, second-generation androgen receptor inhibitors, chemotherapy, immunotherapy, or radiotherapy
- Known allergy to any study drugs or their ingredients
- Unable to undergo CT or MRI scans
- Recent history (within 6 months) of serious heart or stroke events
- Uncontrolled high blood pressure despite treatment
- History of other cancers except certain skin cancers in complete remission
- Gastrointestinal issues or surgeries that may affect drug absorption
- Active hepatitis or HIV infection
- Participation in another drug study within 28 days or 5 half-lives before this study
- Serious or unstable medical conditions that may affect study participation or safety
- Inability to swallow oral medications
- Close relationship with the research center personnel
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
L
Liang Dong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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