Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

Running, not enrolling · Phase 3

Conditions studied: Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8

In brief

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.

Key facts

Study ID: NCT03987386
Run by: M.D. Anderson Cancer Center
People needed: 186
Starts: 2019-05-30
Expected to finish: 2027-11-01
Last updated by the study team: 2026-05-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

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

Full record on ClinicalTrials.gov

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