NCT06198387Not yet recruiting
Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer
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
Source: ClinicalTrials.gov · Last updated 10 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 26 Dec 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Changhai Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06198387
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Jan 2024 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.