Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

Description

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.

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

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Study Overview

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Study Details

Study overview

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.

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

Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

Condition
Stage I Prostate Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

League City

MD Anderson League City, League City, Texas, United States, 77573

Sugar Land

MD Anderson in Sugar Land, Sugar Land, Texas, United States, 77478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Quynh-Nhu Nguyen, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2025-11-01