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Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

NCT03920033 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2021-01-20

No results posted yet for this study

Summary

Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence.

It is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. In addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.

Conditions

  • Prostate Cancer
  • Biochemical Recurrence
  • Radiation
  • Hypofractionation
  • Dose Escalation
  • Survival
  • Radiation Toxicity
  • Quality of Life

Interventions

RADIATION

Salvage radiation therapy

Salvage radiation therapy for biochemical recurrence

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Young Seok Kim, M.D., Ph.D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2022-01-01
Completion
2027-01-01

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03920033 on ClinicalTrials.gov