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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai General Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Bangmin Han, Doctor
• Email: hanbm@163.com
• Phone: 86-021-63240090

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining radiotherapy or surgery with intense hormone therapy for advanced prostate cancer

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  Recruiting Phase 2 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT06992232

• SRT for bone and lymph node metastases in advanced prostate cancer

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• Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy

  This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.

  Recruiting Phase 2 Brigham and Women's Hospital · Boston, Massachusetts · NCT06957691

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.