New hormone therapy plus PSMA PET/CT–guided local treatment for metastatic hormone‑sensitive prostate cancer

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

This trial will test whether adding local treatments guided by PSMA PET/CT to standard hormone therapy helps men with newly diagnosed metastatic hormone‑sensitive prostate cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06832774 on ClinicalTrials.gov

What this trial studies

This single-center Phase 2 trial enrolls men with newly diagnosed metastatic hormone‑sensitive prostate cancer confirmed by PSMA PET/CT who have not received prior prostate cancer therapy. All participants start androgen‑deprivation therapy plus a novel hormone therapy (abiraterone, apalutamide, or rezvilutamide) and undergo repeat PSMA PET/CT after about eight months. Patients with persistent PSMA‑avid lesions may receive metastasis‑directed local treatments in addition to continued systemic therapy. The study aims to see if PSMA imaging can guide individualized addition of local therapy to improve disease control and treatment personalization.

Who should consider this trial

Good fit: Men aged 18 or older with newly diagnosed mHSPC confirmed by PSMA PET/CT, ECOG 0–2, life expectancy over 2 years, and no prior prostate cancer treatment.

Not a fit: Patients who are castration‑resistant, have non‑PSMA‑avid disease, significant organ dysfunction, recent other active cancers, or prior prostate cancer therapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve disease control and personalize treatment by targeting remaining metastases while maintaining effective systemic therapy.

How similar studies have performed: Prior trials combining intensified systemic therapy with metastasis‑directed therapy have shown promise, but using PSMA PET/CT to guide these decisions is relatively new and still has limited clinical evidence.

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. Prostate biopsy shows sarcomatoid cells, ductal carcinoma, or neuroendocrine cell components;
3. Severe complications, immune suppression, severe mental illness, severe activity restriction, or inability to comply with this study;
4. Currently participating in other clinical trials for prostate cancer;
5. According to the researcher's judgment, there are conditions that are not in line with the best interests of the subjects participating in the study, or may hinder, limit, or interfere with the study protocol.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Bangmin Han, Doctor

Conditions: Prostate Cancer Metastatic Disease