Radical Hypofractionated Radiotherapy for Localized Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypofractionated radiation therapy.
- Who it may be relevant to
- Registry conditions: Localized Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial
Overview
The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer. Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects. Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.
Detailed description
The present study will be conducted as a prospective, open-label, single-arm clinical trial.
The patients will receive hypofractionated radiation(54 Gy in 15 daily fractions of 3.6 Gy ). After completion of study treatment, patients were followed up once a month for the first 3 months and once every 3 months after 3 months for a total of 5 years.
The primary endpoints of the study are the toxicities about gastrointestinal (GI),genitourinary (GU) symptoms and erectile dysfunction.The secondary endpoints include progression-free survival (bPFS), local progression-free-survival(LPFS) ,distant metastasis free survival(DMFS) ,overall survival (OS)and quality of life (QoL).
Interventions
- Radiation Hypofractionated radiation therapy
54 Gy in 15 daily fractions of 3.6 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.
Primary outcome measures
- Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events [Time frame: 5 years]
Secondary outcome measures (6)
- biochemical progression-free survival (bPFS) [Time frame: 5 years]
- local progression-free-survival(LPFS) [Time frame: 5 years]
- distant metastasis free survival(DMFS) [Time frame: 5 years]
- Overall survival (OS) [Time frame: 5 years]
- Quality of life (QoL) [Time frame: 5 years]
- Physical Activity Rank Scale-3 (ARS-3) [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Age: ≥18 years old;
- European Cooperative Oncology Group score(ECOG):≤ 2;
- Patients with pathologically diagnosed prostate cancer;
- Clinical stage was cTanyN0M0 any Gleason / ISUP group;
- Expected survival time >5 years;
- The patient has no contraindications to radiotherapy and is suitable and willing to undergo radiotherapy;
- Patients who voluntarily accept the experimental study protocol after being informed about the existing treatment options;
Exclusion criteria
- Patients who have received any other early treatment for prostate cancer, including radiotherapy, chemotherapy, focal therapy, etc;
- a previous history of pelvic and abdominal radiotherapy;
- Prior hormonal therapy (castration or antiandrogen);
- 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;
- Patients with contraindications related to 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 unable to provide written informed consent or demonstrate poor treatment compliance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Changhai hospital — Shanghai
Publications
- Liang Y, Zhang W, Zhao X, Zhang H. Hypofractionated radiotherapy for localized prostate cancer: the protocol for a prospective clinical trial. Future Oncol. 2025 May;21(12):1483-1488. doi: 10.1080/14796694.2025.2489340. Epub 2025 Apr 21. PMID 40257456
Identifiers
NCT: NCT06325774 · Changhai HHospital