Clinical trial NCT06325774: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Localized Prostate Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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

Primary outcomes:
measure: Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events
timeFrame: 5 years
Secondary outcomes:
measure: biochemical progression-free survival (bPFS)
timeFrame: 5 years
measure: local progression-free-survival(LPFS)
timeFrame: 5 years
measure: distant metastasis free survival(DMFS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
measure: Quality of life (QoL)
timeFrame: 5 years
measure: Physical Activity Rank Scale-3 (ARS-3)
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
state: Shanghai
Study officials:
References: