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Trial Title:
Radical Hypofractionated Radiotherapy for Localized Prostate Cancer
NCT ID:
NCT06325774
Condition:
Localized Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Hypofractionated radiation therapy
Description:
54 Gy in 15 daily fractions of 3.6 Gy to the prostate bed in the absence of disease
progression or unacceptable toxicity.
Arm group label:
Hypofractionated Radiotherapy
Summary:
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).
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Changhai hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Huojun Zhang, M.D.
Phone:
+8613311732399
Email:
chyyzhj@163.com
Investigator:
Last name:
Huojun Zhang, M.D.
Email:
Principal Investigator
Start date:
September 1, 2024
Completion date:
September 1, 2031
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06325774