Houston, Texas 77030


Purpose:

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 beam 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.


Study summary:

PRIMARY OBJECTIVES: I. To assess the gastrointestinal (GI) and genitourinary (GU) toxicities in patients treated with hypo-fractionated postoperative radiotherapy relative to the conventional postoperative radiotherapy. SECONDARY OBJECTIVES: I. To report patient outcome to include local control, loco-regional control, distant metastases, biochemical progression-free survival, prostate-cancer specific survival (PCSS), time to salvage therapy. II. To compare freedom from biochemical failure (FFBF) and time to progression (TTP) with definition of post prostatectomy nadir + 2 ng/mL in both treatment arms. III. To evaluate patient reported quality of life outcomes with hypo-fractionated compared to standard fractionated postoperative radiotherapy using validated surveys (Expanded Prostate Cancer Index Composite [EPIC]-26, SF-12) and use of erectile dysfunction medications/devices. IV. To compare patient reported GU symptoms using the EPIC-26 survey at end of radiation therapy (RT), 6, 12, 24 and up to 60 months from the end of radiation therapy. V. To compare patient reported GI symptoms using the EPIC-26 survey at end of RT, 6, 12, 24, and up to 60 months from the end of radiation therapy. VI. To report health economics in delivering shorter hypofractionated courses of radiotherapy compared to standard course (indirect and direct cost). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo conventional radiation therapy daily over 6.5 weeks after standard of care surgery. ARM II: Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery. After completion of study treatment, patients are followed up at 3-6 months, and then every 6-12 months for up to 5 years.


Criteria:

Inclusion Criteria: - 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 T2N0M0 or T3N0M0 stage - Patient diagnosed with Gleason score of 6-10 - For patients radiated in the adjuvant setting: pathology demonstrates positive margin, extracapsular extension, or seminal vesicle involvement without detectable prostate specific antigen (PSA) (PSA of 0.0) - For patients radiated in the salvage setting: pathology demonstrates positive margin, extracapsular extension, seminal vesicle involvement with detectable PSA of > 0.1 - 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 6 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: - Any evidence of nodal positivity beyond pathologic stage pN0 - 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 - 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)


NCT ID:

NCT03987386


Primary Contact:

Principal Investigator
Quynh-Nhu Nguyen
M.D. Anderson Cancer Center

Quynh-Nhu Nguyen
Phone: 713-563-2300
Email: qnnguyen@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Quynh-Nhu Nguyen, MD
Phone: 713-563-2300

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.