Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

Launched by M.D. ANDERSON CANCER CENTER · Jun 11, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to give radiation therapy to men with prostate cancer. One method is called conventional radiation therapy, which is the standard approach, while the other method is called hypofractionated radiation therapy. This newer method delivers higher doses of radiation over a shorter time, and researchers want to see if it can kill more cancer cells and cause fewer side effects. The trial is currently recruiting men aged 18 and older who have been diagnosed with prostate cancer and have undergone surgery to remove the prostate.

To be eligible for the trial, participants should have specific stages of prostate cancer and certain characteristics in their medical history, such as having a Gleason score between 6 and 10, which helps determine the aggressiveness of the cancer. Participants can expect to receive either type of radiation therapy and will be closely monitored throughout the study. It's important to note that men with a history of other serious health issues or prior radiation therapy to the prostate may not qualify for this trial. This study aims to find out if the new method is better, helping improve treatment options for future patients.

Gender

MALE

Eligibility 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)