Combining radiotherapy or surgery with intense hormone therapy for advanced 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 multi-center randomized controlled phase II trial evaluates the effectiveness and safety of combining radiotherapy or radical prostatectomy with intense androgen deprivation therapy in patients newly diagnosed with metastatic prostate cancer. The study focuses on patients with a limited number of metastatic sites that can be treated locally. Participants will undergo either radiotherapy or surgery alongside hormone therapy to assess outcomes. The trial is conducted across several hospitals in China, aiming to provide insights into optimal treatment strategies for this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically or cytologically confirmed prostate adenocarcinoma, with distant metastasis diagnosed by novel imaging modalities (PSMA PET/CT or PSMA PET/MR), involving ≤10 metastatic sites (amenable to local therapy) and without visceral metastasis.
2. The primary lesion is deemed resectable, or can achieve a resectable state following IADT.
3. Non-castration range (≥50 ng/dl), or the duration of testosterone levels in the castration range is no more than 3 months.
4. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
5. Patients must have adequate hematologic function, hepatic function and renal function.
6. Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
7. Fertile patients must be willing to use highly effective contraception during the study period.

Exclusion Criteria:

1. Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features.
2. The researchers assessed the primary lesion as unresectable.
3. Patients who had previously received androgen deprivation therapy (including medical or surgical castration) for more than 3 months, or had undergone focal therapy for prostate cancer, or had received radiotherapy or chemotherapy for prostate cancer.
4. Patients with severe or uncontrolled underlying diseases who could not tolerate surgery or radiotherapy.
5. Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina, or a history of myocardial infarction within the past 6 months.
6. Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent pulmonary disease, chronic liver disease, or HIV infection.
7. Within the past 5 years, having had other malignant tumors except for prostate cancer, with the exception of cured basal or squamous cell skin cancer.
8. Suffering from mental illness, mental disability, or being incapable of providing informed consent.

Where it's running

• Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Hongqian Guo, PhD — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Study coordinator: Junlong Zhuang, PhD
• Email: zhuangjl-2008@163.com
• Phone: +86 15950451917

Similar studies

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

• PSMA-targeted fluorescent dye OTL78 to guide prostate cancer surgery

  This study tests whether the PSMA-targeted fluorescent dye OTL78, used with near-infrared imaging, can help doctors better find and remove prostate cancer tissue during surgery in men with confirmed prostate cancer.

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• Using PSMA PET with MRI to watch for prostate cancer returning after focal therapy

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• Mini-tumors to guide treatment for aggressive prostate cancer

  We will grow tiny, patient-derived mini-tumors in the lab to test which treatments work best for men with aggressive or metastatic prostate cancer.

  Recruiting Maastricht Radiation Oncology · Heerlen, Limburg and 2 other locations · NCT07004582

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

  This trial tests whether treating multiple metastatic lesions with stereotactic radiotherapy can prolong pain control and prevent complications in men with advanced, treatment‑refractory prostate cancer.

  Recruiting Institut Cancerologie de l'Ouest · Saint-Herblain · NCT06978296

• 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

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

  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.

  Recruiting Phase 2 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT06832774

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.