NCT03987386

Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

Post Operative External Beam Radiotherapy for Prostate Cancer: Randomized Trial Comparing Standard vs. Hypofractionated Radiation Therapy (PORT-HYFX)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiation Therapy	Undergo hypofractionated radiation therapy
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Radiation Therapy	Undergo conventional radiation therapy

Timeline

• Start date: 2019-05-30
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2019-06-17
• Last updated: 2025-11-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study