Shorter-course radiotherapy after prostate removal for localized prostate cancer
Compares shorter and standard radiotherapy courses in men with localized prostate cancer after surgery.
Plain-language title generated from the registry record
Registry title: Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- Changhai HospitalShanghai, ChinaTaking people
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
- NCT06325995
- Record updated
- 26 August 2024
- Original description
The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.Read full original descriptionShow less
Safety and Efficacy Study of Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer: a Randomized Controlled Clinical Trial
The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.
Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way.
It is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer.
Inclusion: European Cooperative Oncology Group score(ECOG):≤ 2; Patients with pathologically confirmed prostate cancer and completed radical resection of prostate cancer; Postoperative pathological staging of AJCC version 8 pT 3a, pT 3b, pT 4, margin (+), or N1; or serum PSA≥0.1 ng/ml 6 weeks after surgery; or serum PSA <0.1 ng/ml 6 weeks after surgery, subsequent follow-up process revealed two consecutive sustained PSA increases (≥0.1 ng / ml) and no clinical imaging (Whole Body Scan (ECT), magnetic resonance imaging (MRI),68Ga PSMA PET / CT, etc.) signs of metastasis; Expected survival time >5 years; Patients who voluntarily accept the experimental study protocol after informing the existing treatment options.
Exclusion: a previous history of pelvic and abdominal radiotherapy; Participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study; Patients with contraindications related to radiotherapy; Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis; Patients that the investigator considers unsuitable to participate in the clinical trial; patients with other serious systemic diseases, evaluation and compliance of the trial, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary, and other systemic diseases; poor recovery of postoperative urinary control; Written informed consent could not be provided, and treatment compliance was poor.Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.