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.
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;
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)
Single group
hormone and RT
RadiationThe patients will receive a two-year course of androgen deprivation therapy (ADT) in combination with abiraterone, along with synchronous metastasis-directed radiation and prostate radiotherapy(RT).
ADT combined with abiraterone
DrugThe patients will receive a two-year course of ADT combined with abiraterone.
progression-free survival 2 (PFS2)
To assess the duration from the reinitiation of endocrine therapy until the identification of disease progression again.
ADT free survival
To assess the timeframe between the completion of the initial ADT treatment and the onset of the subsequent ADT treatment.
self-assessment of quality of life (QoL) and patient satisfaction
To evaluate utilizing QoL questionnaires.In the EQ-5D descriptive system five dimensions are assessed: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patients are asked to rate each dimension on a scale ranging from 'no problems'(1) to 'unable to/ extreme problems'(5).The VAS is a vertical scale ranging from 0 to 100 where 0 indicates worst imaginable health and 100 indicates best imaginable health.
5-year overall survival (OS)
To assess the duration from enrollment until death from any cause or the last follow-up.
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