Hypofractionated radiotherapy for localized prostate cancer: the protocol for a prospective clinical trial.
Yiyin Liang, Weiwei Zhang, Xianzhi Zhao...
https://pubmed.ncbi.nlm.nih.gov/40257456Actively Recruiting
Phase Not Applicable
Age: 18Years +
MALE
ID06325774
Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial
Led by Changhai Hospital · Updated on 2024-08-26
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety outcomes of hypofractionated radiotherapy in patients with localized prostate cancer. This approach delivers higher doses of radiation in a shorter time, potentially killing more tumor cells while causing fewer side effects. Although evidence supports its safety and feasibility, the optimal dose per treatment for localized prostate cancer is still being determined. Participants will receive hypofractionated radiation therapy with a total dose of 54 Gy delivered in 15 daily treatments of 3.6 Gy each over three weeks. After completing treatment, patients will be followed up monthly for the first three months and then every three months for up to five years to monitor health and treatment effects. During the study, researchers will assess side effects related to the gastrointestinal and urinary systems, as well as erectile function. They will also track progression-free survival, local control, distant metastasis, overall survival, quality of life, and physical activity over five years. Safety and patient well-being will be closely monitored throughout the trial period.
CONDITIONS
Brief Title
Radical Hypofractionated Radiotherapy for Localized Prostate Cancer
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- European Cooperative Oncology Group (ECOG) score of 2 or less
- Pathologically diagnosed with prostate cancer
- Clinical stage cTanyN0M0 with any Gleason or ISUP group
- Expected survival time greater than 5 years
- No contraindications to radiotherapy and suitable for treatment
- Willing and able to follow the study protocol after informed consent
You will not qualify if you...
- Previous early treatment for prostate cancer such as radiotherapy, chemotherapy, or focal therapy
- History of pelvic or abdominal radiotherapy
- Prior hormonal therapy including castration or antiandrogen
- Presence of other cancers or infections like HIV, hepatitis C, or syphilis
- Serious systemic diseases affecting respiratory, circulatory, neurological, mental, digestive, endocrine, immune, or urinary systems
- Contraindications related to radiotherapy
- Participation in other conflicting clinical trials within 4 weeks before study start
- Unable to provide written informed consent or poor treatment compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 weeks
Participants receive hypofractionated radiation therapy consisting of 54 Gy delivered in 15 daily fractions of 3.6 Gy to the prostate bed.
15 daily visits (in-person) for radiation therapy
Follow-up
Duration - 5 years
After treatment, participants are followed up to monitor for toxicities, disease progression, and quality of life.
Monthly visits for the first 3 months, then visits every 3 months up to 5 years
Trial Site Locations
Total: 1 location
1
Changhai hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
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Research Team
H
Huojun Zhang
X
Xianzhi Zhao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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