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Post Operative External Beam Radiotherapy for Prostate Cancer: Randomized Trial Comparing Standard vs. Hypofractionated Radiation Therapy (PORT-HYFX)
This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
PRIMARY OBJECTIVE: I. To assess the gastrointestinal (GI) and genitourinary (GU) toxicities in patients treated with hypo-fractionated postoperative radiotherapy relative to the conventional postoperative radiotherapy. SECONDARY OBJECTIVES: I. To report patient outcome to include local control, loco-regional control, distant metastases, biochemical progression-free survival, prostate-cancer specific survival (PCSS), time to salvage therapy. Ia. To compare freedom from biochemical failure (FFBF) and time to progression (TTP) with definition of post prostatectomy nadir + 2 ng/mL in both treatment arms. II. To evaluate patient reported quality of life outcomes with hypo-fractionated compared to standard fractionated postoperative radiotherapy using validated surveys (Expanded Prostate Cancer Index Composite \[EPIC\]-26, Short Form \[SF\]-12, EuroQol 5 dimensional \[EQ-5D\]) and use of erectile dysfunction medications/devices. III. To compare patient reported GU symptoms using the Common Terminology Criteria for Adverse Events (CTCAE) version 5 (specifically GU symptoms) and quality of life reports with EPIC-26, SF-12, EQ-5D survey at end of radiation therapy (RT), 6, 12, 24 and up to 60 months from the end of radiation therapy. IV. To compare patient reported GI symptoms using CTCAE version 5 (specifically GI symptoms) and quality of life reports with the EPIC-26 SF-12, EQ-5D survey at end of RT, 6, 12, 24, and up to 60 months from the end of radiation therapy. V. To report health economics with cost and time based driven activity (TDABC) in delivering shorter hypofractionated courses of radiotherapy compared to standard course (indirect and direct cost). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery. ARM II: Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery. After completion of study treatment, patients are followed up at 3-6 months, and then every 6-12 months for up to 5 years.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
M D Anderson Cancer Center
Houston, Texas, United States
MD Anderson League City
League City, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
Start Date
May 30, 2019
Primary Completion Date
November 1, 2027
Completion Date
November 1, 2027
Last Updated
November 12, 2025
186
ACTUAL participants
Hypofractionated Radiation Therapy
RADIATION
Quality-of-Life Assessment
OTHER
Questionnaire Administration
OTHER
Radiation Therapy
RADIATION
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT04550494
NCT07073794
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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