Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer

Not Applicable

Recruiting

• Conditions: Localized Prostate Cancer

• Registration Number: NCT06325995
• Lead Sponsor: Changhai Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 428

Inclusion Criteria

Inclusion Criteria:<br><br> - European Cooperative Oncology Group score(ECOG):= 2;<br><br> - Patients with pathologically confirmed prostate cancer and completed radical<br> resection of prostate cancer;<br><br> - Postoperative pathological staging of AJCC version 8 pT 3a, pT 3b, pT 4, margin (+),<br> or N1; or serum PSA=0.1 ng/ml 6 weeks after surgery; or serum PSA <0.1 ng/ml 6 weeks<br> after surgery, subsequent follow-up process revealed two consecutive sustained PSA<br> increases (=0.1 ng / ml) and no clinical imaging (Whole Body Scan (ECT), magnetic<br> resonance imaging (MRI),68Ga PSMA PET / CT, etc.) signs of metastasis;<br><br> - Expected survival time >5 years;<br><br> - Patients who voluntarily accept the experimental study protocol after informing the<br> existing treatment options;<br><br>Exclusion Criteria:<br><br> - poor recovery of postoperative urinary control;<br><br> - a previous history of pelvic and abdominal 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 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> - Written informed consent could not be provided, and treatment compliance was<br> poor.Patients unsuitable for participation in this clinical trial as per the<br> judgement of the investigator.

Exclusion Criteria

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
5-year progression-free survival (PFS);quality of life (QoL);medical expenses;Overall survival (OS);Prostate cancer-specific survival;Physical Activity Rank Scale-3 (ARS-3)