Radical Hypofractionated Radiotherapy for Localized Prostate Cancer

Localized Prostate Cancer Clinical Trial

Official title:

Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325774
• Other study ID #: Changhai HHospital
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2031

Study information

• Verified date: March 2024
• Source: Changhai Hospital
• Contact: Huojun Zhang
• Phone: 021-31162222
• Email: huojunzh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 1, 2031
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Localized Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events	RTOG / EORTC scale, Common Terminology Criteria for Adverse Events (CTCAE) 5.0, erectile dysfunction.	5 years
Secondary	biochemical progression-free survival (bPFS)	The definition of biochemical failure is a PSA measurement = PSA nadir + 2 ng/mL where nadir is the lowest post-RT PSA value.Time to biochemical failure is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk).	5 years
Secondary	local progression-free-survival(LPFS)	Response evaluation criteria in solid tumor(RECIST)1.1:To determine the outcome of treatment for solid tumors,The efficacy according the diameter of the lesion could be divided into complete response(CR),partial response(PR),stable disease(SD)and progressive disease(PD).	5 years
Secondary	distant metastasis free survival(DMFS)	Distant metastasis (failure) is defined as radiographic evidence of hematogenous spread evaluated by bone scan, CT, or MRI. Time to distant metastasis is defined as time from randomization to the date of first distant metastasis, last known follow-up (censored), or death without local recurrence (competing risk).	5 years
Secondary	Overall survival (OS)	Overall survival time is defined as time from registration/randomization to the date of death (failure) from any cause or last known follow-up (censored).	5 years
Secondary	Quality of life (QoL)	Expanded Prostate Cancer Index (EPIC-26):The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL.	5 years