Actively Recruiting
Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-03-25
192
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatment options for metastatic hormone sensitive prostate cancer (mHSPC), focusing on combining novel hormone therapy (NHT) with local treatment. The study aims to clarify how to create more personalized treatment plans, especially using prostate-specific membrane antigen (PSMA) PET/CT scans to identify active cancer lesions after initial therapy. This study is a Phase 2 trial evaluating the effects of adding local treatment to NHT in patients with remaining active lesions seen on PSMA PET/CT after 8 months of hormone therapy. Participants will receive gonadotropin releasing hormone analog (GnRHa) plus NHT, which may include drugs like abiraterone, apalutamide, or rezvilutamide, chosen based on clinical guidelines. After 8 months of this therapy, PSMA PET/CT scans will reassess active lesions. Patients with persistent active lesions will be randomized to continue NHT alone or to receive NHT combined with local treatments such as radiotherapy, orthopedic surgery for bone lesions, or high-energy focused ultrasound for lymph node lesions. Treatment plans are tailored by researchers according to patient conditions. During the study, participants will be monitored to measure progression-free survival from enrollment until 12 weeks after treatment. Assessments include clinical evaluations and imaging with PSMA PET/CT to track disease status. The study will provide insights into whether adding local treatment delays disease progression and improves survival for mHSPC patients. The trial is sponsored by Shanghai General Hospital and will run until December 2028.
CONDITIONS
Brief Title
Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients over the age of 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Expected lifespan greater than 2 years
- Newly diagnosed metastatic hormone sensitive prostate cancer confirmed by PSMA PET/CT with active lesions after new endocrine therapy
- No prior treatment for prostate cancer
- No significant organ dysfunction
- Signed informed consent indicating understanding and willingness to participate
You will not qualify if you...
- History of any other active malignant tumor within 2 years except certain fully treated skin or bladder cancers in remission
- Prostate biopsy showing sarcomatoid cells, ductal carcinoma, or neuroendocrine components
- Severe complications, immune suppression, mental illness, or activity restrictions preventing study compliance
- Current participation in other prostate cancer clinical trials
- Any condition judged by the researcher to be unsuitable or interfering with the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive gonadotropin releasing hormone analog combined with novel hormone therapy, with or without local treatment such as radiotherapy or surgery, based on their clinical condition.
Regular visits as scheduled by the study team during treatment
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
B
Bangmin Han, Doctor
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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