NCT03987386Active, not recruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 186 (actual)
- First submitted
- 25 Jan 2019
- Start date
- 30 May 2019
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT03987386
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 186
- From 30 May 2019 to the primary completion date, 1 Nov 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiation therapy to prostate/seminal vesicle fossa or postoperative region
- Neoadjuvant chemotherapy before or after prostatectomy
Other illness
- History of lupus, scleroderma, or calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome
- History of severe active co-morbidity or uncontrolled diabetes
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
- End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
Who the study is looking for
- Men age 18 or older
- Patient has diagnosis of pathologically confirmed prostate cancer, treated with radical prostatectomy. Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted
- Patient has pathologic T2-T3M0 stage. Patients can have 5 or less metastatic pelvic lymph nodes confirmed by pathology
- For patients radiated in the post-operative salvage setting: pathology can demonstrate any of the following features but not required, positive margin, extracapsular extension, or seminal vesicle involvement with detectable prostate-specific antigen (PSA) of \>= 0.1. PSA \>= 0.1 after radical prostatectomy: most recent PSA value within 12 months of registration and prior to initiating any androgen deprivation therapy (ADT)
- Patient diagnosed with Gleason score of 6-10
- Eastern Cooperative Oncology Group (ECOG) performance 0-2
- Patients may receive 6 months and up to 24 months of androgen deprivation therapy. Patients may have received androgen deprivation therapy up to 12 months prior to postoperative radiotherapy
- If the patient has a prior history of any cancer other than prostate cancer, he must have completed treatment within 1 year of study registration and the patient must have no evidence of disease of this prior non-prostate cancer
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MD Anderson League City Coordinator of this site? Confirm its status | League City | United States | Unknown status |
| MD Anderson in Sugar Land Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.