Radiotherapy for the Prostate and Few Spread Sites in Prostate Cancer
Tests radiotherapy to prostate and spread sites in oligo-metastatic prostate cancer.
Plain-language title generated from the registry record
Registry title: Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06198387, who can take part
Where in China
- Shanghai Changhai HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Changhai Hospital
- Trial code
- NCT06198387
- Record updated
- 10 January 2024
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer: An Open, Exploratory Pilot Clinical 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.
Inclusion: 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: Any previous or ongoing treatment for prostate cancer, including radiotherapy, chemotherapy, focal treatment, etc; 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); Individuals with contraindications related to radiation therapy may present heightened risks of treatment-related complications; 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; Pathology indicating small-cell or neuroendocrine tumor components; Patients with visceral metastases, or ≥4 metastases; Patients participating in other clinical trials; Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.