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
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
At present, there is still controversy over the treatment of metastatic hormone sensitive prostate cancer (mHSPC). Major guidelines and consensus suggest that novel hormone therapy (NHT) should be used as the basic treatment for mHSPC, and metastasis directed therapy can be combined depending on the clinical situation. However, it is still unclear how to develop more specific and individualized treatment plans for mHSPC patients. On the other hand, prostate-specific membrane antigen (PSMA) which is highly specifically expressed in prostate epithelial cells has been widely used as a PET/CT target for the diagnosis and staging of prostate cancer. However, there is still a lack of clinical evidence on how to use it to guide the treatment of prostate cancer. Therefore, this study intends to include patients diagnosed with mHSPC by PSMA PET/CT. The patients received no prior treatment for prostate cancer or ADT plus NHT therapy only. After 8 months of ADT plus NHT, PSMA PET/CT will be re-evaluated and patients with remaining active lesions on PSMA PET/CT will be included for randomization. The aim of this study is to explore the effect of NHT combined with local treatment on delaying disease progression and prolonging survival in patients with active lesions on PSMA PET/CT after NHT, providing new insights into the treatment of mHSCP patients.
CONDITIONS
Official 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 score of 0, 1, or 2
- Expected lifespan greater than 2 years
- Newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) confirmed by PSMA PET/CT with active lesions after novel hormone therapy
- No prior treatment for prostate cancer
- No significant organ dysfunction upon evaluation
- Signed written 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 fully treated basal cell or squamous cell skin cancer, superficial bladder cancer, or other cancers in complete remission)
- Prostate biopsy showing sarcomatoid cells, ductal carcinoma, or neuroendocrine components
- Severe complications, immune suppression, severe mental illness, or severe activity restrictions preventing study compliance
- Currently participating in other prostate cancer clinical trials
- Any condition judged by the researcher to be unsuitable or interfering with study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
B
Bangmin Han, Doctor
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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