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NCT06832774PHASE2RECRUITING

Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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Key Facts

Study type
INTERVENTIONAL
Conditions
Prostate Cancer Metastatic Disease
Interventions
Local treatment, Gonadotropin releasing hormone analog (GnRHa) + Novel hormone therapy (abiraterone, apalutamide or rezvilutamide).
Enrollment
192 participants
Primary completion
Dec 2027
Study completion
Dec 2028
First posted
Feb 2025
Last updated
Mar 2026

Primary Endpoints (CT.gov)

Progression free survival, PFS

Time frame: From enrollment to the end of treatment at 12 weeks

Eligibility Criteria

Inclusion Criteria: 1. Male patients over the age of 18; 2. The physical condition (PS) score of the Eastern Cooperative Oncology Group (ECOG) is 0, 1, or 2 points; 3. Expected lifespan \>2 years; 4. All newly diagnosed patients with metastatic prostate cancer (mHSPC, metastatic hormone sensitive prostate cancer) diagnosed by PSMA PET/CT, and still present active lesions on PSMA PET/CT after receiving new endocrine therapy; 5. Has not received any other treatment for prostate cancer before; 6. No significant organ dysfunction upon evaluation; 7. Agreed to sign the written consent form for this study, indicating a comprehensive understanding of the purpose and process of this study, and willingness to participate in this study. Exclusion Criteria: 1. A medical history of any other active malignant tumor within 2 years (excluding fully treated basal cell or squamous cell skin cancer, superficial bladder cancer or any other cancer in situ that is currently in complete remission); 2. Pr

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov