Radical Hypofractionated Radiotherapy for Localized Prostate Cancer
- Conditions
- Localized Prostate Cancer
- Registration Number
- NCT06325774
- Lead Sponsor
- Changhai Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Age: =18 years old;<br><br> - European Cooperative Oncology Group score(ECOG):= 2;<br><br> - Patients with pathologically diagnosed prostate cancer;<br><br> - Clinical stage was cTanyN0M0 any Gleason / ISUP group;<br><br> - Expected survival time >5 years;<br><br> - The patient has no contraindications to radiotherapy and is suitable and willing to<br> undergo radiotherapy;<br><br> - Patients who voluntarily accept the experimental study protocol after being informed<br> about the existing treatment options;<br><br>Exclusion Criteria:<br><br> - Patients who have received any other early treatment for prostate cancer, including<br> radiotherapy, chemotherapy, focal therapy, etc;<br><br> - a previous history of pelvic and abdominal radiotherapy;<br><br> - Prior hormonal therapy (castration or antiandrogen);<br><br> - Patients with other malignancies and acute or chronic infections such as human<br> immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive<br> syphilis;<br><br> - Patients that the investigator considers unsuitable to participate in the clinical<br> trial; patients with other serious systemic diseases, evaluation and compliance of<br> the trial, including severe respiratory, circulatory, neurological, mental,<br> digestive, endocrine, immune, urinary, and other systemic diseases;<br><br> - Patients with contraindications related to radiotherapy;<br><br> - Participate in other clinical trials that are mutually exclusive with the study<br> intervention within 4 weeks prior to the start of the study;<br><br> - Patients unable to provide written informed consent or demonstrate poor treatment<br> compliance
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events
- Secondary Outcome Measures
Name Time Method biochemical progression-free survival (bPFS);local progression-free-survival(LPFS);distant metastasis free survival(DMFS);Overall survival (OS);Quality of life (QoL);Physical Activity Rank Scale-3 (ARS-3)