Radical hypofractionated radiotherapy for localized prostate cancer
Official title: Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial
Run by Changhai Hospital · NCT06325774 · Data updated 2026-11-12
This study is testing a new way of giving radiation therapy to see if it can safely treat localized prostate cancer while causing fewer side effects.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 20 (estimated) |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2031 |
| Registry record updated | August 26, 2024 |
| Trial ID | NCT06325774 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult males aged 18 and older with pathologically diagnosed localized prostate cancer and an expected survival time of more than five years.
✕Probably not a fit
Patients who have previously undergone treatments for prostate cancer or have other malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the safety outcomes of hypofractionated radiotherapy in patients with localized prostate cancer. The approach involves delivering higher doses of radiation over a shorter time frame, which may enhance tumor cell destruction while minimizing side effects. Patients will receive a total of 54 Gy in 15 daily fractions of 3.6 Gy, followed by a structured follow-up for five years to monitor various health outcomes. The study aims to assess both the primary toxicities related to gastrointestinal and genitourinary symptoms, as well as secondary endpoints like progression-free survival and overall quality of life.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and less burdensome option for patients with localized prostate cancer.
How similar studies have gone: Accumulating evidence suggests that hypofractionated radiotherapy has been safe and feasible for localized prostate cancer, indicating potential success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Changhai hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Huojun Zhang
- Email: huojunzh@163.com
- Phone: 021-31162222
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Intraoperative Hyperspectral Imaging to guide prostate cancer removal
This study tests a hyperspectral imaging device during prostate surgery to see if it can help identify cancer at the edges of the removed tissue in men with localized prostate cancer.
-
Focal Micro-boost Radiotherapy for Localized Prostate Cancer
This study tests whether adding a small, targeted boost to MRI-visible prostate lesions during moderately hypofractionated radiotherapy can improve cancer control in men with localized intermediate- to high-risk prostate cancer.
-
Sonablate HIFU Registry for Prostate Cancer and BPH
This registry collects real-world data from men treated with Sonablate HIFU to see how well it works and how it affects urinary and sexual function over the long term.
-
Water IV: See if Aquablation helps localized prostate cancer patients choose active surveillance
This trial tests whether Aquablation therapy can be as safe and effective as choosing active surveillance for men with localized prostate cancer who are considering surveillance instead of immediate treatment.
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Whole-gland prostate dose boost versus SBRT alone for PSMA-staged localized and locally advanced prostate cancer
We will test whether adding a whole-gland radiation boost (with brachytherapy or a stereotactic boost) improves cancer control compared with SBRT alone in men whose prostate cancer is confined to the prostate on PSMA PET.
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Oxybutynin ER to help early urinary continence after robotic prostatectomy
This trial will test whether taking a daily extended-release oxybutynin pill helps men regain urinary control sooner after robot-assisted prostate removal.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.