Radical Hypofractionated Radiotherapy for Localized Prostate Cancer

NCT06325774 | Recruiting

• 1 other identifier: Changhai HHospital
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• biochemical progression-free survival (bPFS)

  5 years

• local progression-free-survival(LPFS)

  5 years

• distant metastasis free survival(DMFS)

  5 years

• Overall survival (OS)

  5 years

• Quality of life (QoL)

  5 years

Study Arms (1)

Hypofractionated Radiotherapy

EXPERIMENTAL

Hypofractionated Radiotherapy over 3 weeks.

Radiation: Hypofractionated radiation therapy

Interventions

Hypofractionated radiation therapy RADIATION

54 Gy in 15 daily fractions of 3.6 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.

Hypofractionated Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (1)

• Liang Y, Zhang W, Zhao X, Zhang H. Hypofractionated radiotherapy for localized prostate cancer: the protocol for a prospective clinical trial. Future Oncol. 2025 May;21(12):1483-1488. doi: 10.1080/14796694.2025.2489340. Epub 2025 Apr 21.

  PMID: 40257456 DERIVED

Central Study Contacts

Huojun Zhang

CONTACT

021-31162222; huojunzh@163.com

Xianzhi Zhao

CONTACT

021-31162222; zhxzh0007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 22, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2031
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 5 years after the publication of the study.
• Access Criteria: Data may be shared with radiation oncologists and specialists in surgerywho are interested in examining the efficacy and toxicity of localized prostate cancer treated with radical hypofractionated radiotherapy. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.

Locations

CN (1)