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

• Status: Not yet recruiting
• Trial end date: 2028-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changhai Hospital
• Treatments: Hormones

Criteria

Inclusion Criteria:

• 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;

• Expected survival duration >2 years.

• The willingness of patients to voluntarily accept the experimental research protocol after being informed of existing treatment options.

Exclusion Criteria:

• 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)

• Severe or active systemic comorbidities that, in the investigator's judgment, might interfere with the treatment, evaluation, and compliance of this trial, including severe conditions affecting respiratory, circulatory, nervous, mental, digestive, endocrine, immune, urological, and other systems;

• Individuals with contraindications related to radiation therapy may present heightened risks of treatment-related complications.

• Patients participating in other clinical trials;

• Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.