Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-75
SponsorChanghai Hospital

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

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators