About this trial
The existing large prospective study demonstrates the benefits of primary radiotherapy in patients with low-volume oligo-metastatic prostate cancer (OMPC), and there is also more evidence of the benefits of local metastasis-directed therapy (MDT) for metastatic lesions. But there is no results from prospective study to demonstrate the efficacy of radiotherapy for prostate and oligo-metastases. Therefore, the aim of the protocol is to illustrate the efficacy of radiotherapy for prostate and oligo-metastatic lesions in patients with de novo OMPC.
Eligibility criteria
Qualifiers
Aged 18 years or over at the time of registration
Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
Histologically confirmed prostate adenocarcinoma via prostate biopsy;
Assessment conducted via single-photon emission computed tomography (SPECT), magnetic resonance imaging (MRI), and Ga-68 prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography(PET/CT), revealing oligo-metastasis (involving < 4 metastatic lesions in non-pelvic lymph nodes and bones) with or without pelvic lymph node involvement;
Disqualifiers
Any previous or ongoing treatment for prostate cancer, including radiotherapy, chemotherapy, focal treatment, etc.
Pathology indicating small-cell or neuroendocrine tumor components;
Patients with visceral metastases, or ≥4 metastases;
Patients with concurrent malignancies or those in an acute infection period or severe infection state; patients positive for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), and/or syphilis (Treponema pallidum)
Trial design
Treatments tested in this trial
- hormone and RT
- ADT combined with abiraterone