Comparing two types of radiation therapy for prostate cancer treatment
Post Operative External Beam Radiotherapy for Prostate Cancer: Randomized Trial Comparing Standard vs. Hypofractionated Radiation Therapy (PORT-HYFX)
This study is testing if a new type of radiation therapy for prostate cancer can give better results and cause fewer side effects than the standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Houston, Texas and 2 other locations) |
| Trial ID | NCT03987386 on ClinicalTrials.gov |
What this trial studies
This phase III trial evaluates the effectiveness of hypofractionated radiation therapy versus conventional radiation therapy in treating patients with prostate cancer. The study focuses on assessing gastrointestinal and genitourinary toxicities, as well as patient outcomes such as local control and biochemical progression-free survival. Participants will complete quality of life assessments using validated surveys throughout the treatment and follow-up period. The goal is to determine if the hypofractionated approach can provide better results with fewer side effects.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 or older with pathologically confirmed prostate cancer who have undergone radical prostatectomy.
Not a fit: Patients with prostate cancer who have not undergone surgery or have advanced metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for prostate cancer patients with fewer side effects.
How similar studies have performed: Other studies have shown promising results with hypofractionated radiation therapy, suggesting potential benefits over conventional methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Prior radiation therapy to prostate/seminal vesicle fossa or postoperative region * Neoadjuvant chemotherapy before or after prostatectomy * 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)
Where this trial is running
Houston, Texas and 2 other locations
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- MD Anderson League City — League City, Texas, United States (Recruiting)
- MD Anderson in Sugar Land — Sugar Land, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Quynh-Nhu Nguyen — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.