Radical Hypofractionated Radiotherapy for Localized Prostate Cancer

March 16, 2024 updated by: Zhang Huo Jun, Changhai Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:
        • Principal Investigator:
          • Huojun Zhang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated Radiotherapy
Hypofractionated Radiotherapy over 3 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events
Time Frame: 5 years
RTOG / EORTC scale, Common Terminology Criteria for Adverse Events (CTCAE) 5.0, erectile dysfunction.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biochemical progression-free survival (bPFS)
Time Frame: 5 years
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
local progression-free-survival(LPFS)
Time Frame: 5 years
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
distant metastasis free survival(DMFS)
Time Frame: 5 years
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
Overall survival (OS)
Time Frame: 5 years
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
Quality of life (QoL)
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

March 16, 2024

First Submitted That Met QC Criteria

March 16, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Changhai HHospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.

IPD Sharing Time Frame

Within 5 years after the publication of the study.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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