Prostate Cancer Clinical Trial
Hypofractionated Radiation Therapy or Conventional Radiation Therapy After Surgery in Treating Patients With Prostate Cancer
Summary
This randomized phase III trial studies how well hypofractionated radiation therapy works compared to conventional radiation therapy after surgery in treating patients with prostate cancer. 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. Conventional radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. It is not yet known whether giving hypofractionated radiation therapy or conventional radiation therapy after surgery may work better in treating patients with prostate cancer.
Full Description
PRIMARY OBJECTIVES:
I. To demonstrate that hypofractionated post-prostatectomy radiotherapy (HYPORT) does not increase patient-reported gastrointestinal (GI) or genitourinary (GU) symptoms over conventionally fractionated post-prostatectomy (COPORT) at the 2-year time point.
SECONDARY OBJECTIVES:
I. To compare patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)-26 at end of radiation therapy (RT) and 6, 12, 24, and 60 months from end of treatment.
II. To compare patient-reported GU symptoms using the EPIC-26 at end of RT and 6, 12, 24, and 60 months from end of treatment.
III. To compare the cost effectiveness based on the cost of radiotherapy and measured utilities for health outcomes using the EuroQol five dimensions questionnaire (EQ-5D).
IV. To compare time to progression (TTP) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (prostate cancer specific mortality [PCSM]).
V. To compare freedom from biochemical failure (FFBF) and TTP rates with an alternate prostate specific antigen (PSA) >= PSA nadir + 2 ng/mL definition of BF.
VI. To compare local failure, regional failure, salvage therapy (i.e. institution of new unplanned anticancer treatment), DM, PCSM, and overall survival (OS) rates.
VII. Assessment of adverse events. VIII. Paraffin-embedded tissue block, serum, plasma, whole blood, and urine for future translational research analyses for predictors of toxicity following hypofractionated or conventionally fractionated post-prostatectomy radiotherapy.
After completion of study treatment, patients are followed up every 6 months for 2 years and every year for 3 years and thereafter.
Eligibility Criteria
Inclusion Criteria:
PRIOR TO STEP 1 REGISTRATION
Adenocarcinoma of the prostate treated primarily with radical prostatectomy
Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted; there is no time limit for the date of radical prostatectomy
One of the following pathologic T-classifications: pT2 or pT3
Patients with positive surgical margins are eligible
One of the following pathologic N-classifications: pN0, pNX
If a lymph node dissection is performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator versus (vs.) extended lymph node dissection) should be noted whenever possible
No clinical evidence of regional lymph node metastasis
Computed tomography (CT) (with contrast if renal function is acceptable; a noncontrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection of the pelvis within 120 days prior to step 1 registration
Patients with pelvic lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1 cm in the short axis
A post-radical prostatectomy study entry PSA >= 45 days after prostatectomy and within 30 days prior to step 1, < 2.0 ng/mL
No evidence of a local recurrence in the prostate fossa based on a digital rectal examination (DRE) within 60 days prior to step 1 registration
Patients with equivocal or questionable DRE findings should have an MRI of the pelvis to exclude the presence of a prostate fossa mass
Patients with equivocal or questionable exam findings by DRE or MRI are eligible if a biopsy of the lesion is negative for tumor
No evidence of bone metastases (M0) on bone scan (Na F positron emission tomography (PET)/CT is an acceptable substitute) within 120 days prior to step 1 registration
Equivocal bone scan findings are allowed if plain films and/or MRI are negative for metastasis
Zubrod performance status 0-1 within 60 days prior to step 1 registration
The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration
Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire
Only English and French-speaking patients are eligible to participate
PRIOR TO STEP 2 REGISTRATION
The EPIC-26 must be completed in full and entered within 10 business days after step 1 registration; NRG Oncology Statistical and Data Management Center has 3 business days to score the results and send a notification to the site to proceed to step 2 randomization
Exclusion Criteria:
A post-prostatectomy PSA nadir >= 0.2 ng/mL AND Gleason >= 7
pT2 with a negative surgical margin and PSA < 0.1 ng/mL
Androgen deprivation therapy started prior to prostatectomy for > 6 months (180 days) duration;
Note: The use of finasteride or dutasteride (? tamsulosin) for longer periods prior to prostatectomy is acceptable
Androgen deprivation therapy started after prostatectomy and prior to step 1 registration for > 6 weeks (42 days)
Neoadjuvant chemotherapy before or after prostatectomy
Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years and not in the pelvis; (for example, carcinoma in situ of the oral cavity is permissible if disease free for a minimum of 3 years; however, patients with prior history of bladder cancer are not allowed no matter the disease free duration); prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy is not allowed
Previous chemotherapy for any other disease site if given within 3 years prior to step 1
Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy treatment volumes
Severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 1 registration
Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
End-stage renal disease (ie, on dialysis or dialysis has been recommended)
Prior allergic reaction to the study drugs involved in this protocol
History of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any reason, or prior partial/radical cystectomy for any reason
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There are 231 Locations for this study
Birmingham Alabama, 35233, United States
Mobile Alabama, 36688, United States
Little Rock Arkansas, 72205, United States
Greenbrae California, 94904, United States
Greenbrae California, 94904, United States
Los Angeles California, 90027, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90048, United States
Marysville California, 95901, United States
Oakland California, 94611, United States
Palo Alto California, 94304, United States
Pomona California, 91767, United States
Rancho Cordova California, 95670, United States
Rohnert Park California, 94928, United States
Roseville California, 95678, United States
Sacramento California, 95817, United States
Sacramento California, 95823, United States
Santa Clara California, 95051, United States
South San Francisco California, 94080, United States
Truckee California, 96161, United States
Aurora Colorado, 80045, United States
Colorado Springs Colorado, 80907, United States
Colorado Springs Colorado, 80909, United States
New Haven Connecticut, 06520, United States
Newark Delaware, 19713, United States
Newark Delaware, 19718, United States
Rehoboth Beach Delaware, 19971, United States
Seaford Delaware, 19973, United States
Coral Gables Florida, 33146, United States
Deerfield Beach Florida, 33442, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33136, United States
Weston Florida, 33331, United States
Atlanta Georgia, 30303, United States
Atlanta Georgia, 30308, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Savannah Georgia, 31405, United States
'Aiea Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Carterville Illinois, 62918, United States
Chicago Illinois, 60637, United States
Decatur Illinois, 62526, United States
Effingham Illinois, 62401, United States
Maywood Illinois, 60153, United States
New Lenox Illinois, 60451, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61637, United States
Rockford Illinois, 61114, United States
Urbana Illinois, 61801, United States
Goshen Indiana, 46526, United States
Ames Iowa, 50010, United States
Des Moines Iowa, 50309, United States
Kansas City Kansas, 66160, United States
Olathe Kansas, 66061, United States
Overland Park Kansas, 66210, United States
Topeka Kansas, 66606, United States
Wichita Kansas, 67214, United States
Owensboro Kentucky, 42303, United States
Metairie Louisiana, 70006, United States
New Orleans Louisiana, 70121, United States
Portland Maine, 04102, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21201, United States
Columbia Maryland, 21044, United States
Elkton Maryland, 21921, United States
Glen Burnie Maryland, 21061, United States
Boston Massachusetts, 02118, United States
Lowell Massachusetts, 01854, United States
Plymouth Massachusetts, 02360, United States
Ann Arbor Michigan, 48106, United States
Brownstown Michigan, 48183, United States
Clarkston Michigan, 48346, United States
Clarkston Michigan, 48346, United States
Clinton Township Michigan, 48038, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Farmington Hills Michigan, 48334, United States
Farmington Hills Michigan, 48334, United States
Flint Michigan, 48503, United States
Flint Michigan, 48532, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Kalamazoo Michigan, 49007, United States
Lansing Michigan, 48910, United States
Lansing Michigan, 48912, United States
Lapeer Michigan, 48446, United States
Livonia Michigan, 48154, United States
Mount Clemens Michigan, 48043, United States
Mount Pleasant Michigan, 48858, United States
Owosso Michigan, 48867, United States
Petoskey Michigan, 49770, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Troy Michigan, 48098, United States
West Bloomfield Michigan, 48322, United States
Wyoming Michigan, 49519, United States
Duluth Minnesota, 55805, United States
Mankato Minnesota, 56001, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Cape Girardeau Missouri, 63703, United States
Creve Coeur Missouri, 63141, United States
Kansas City Missouri, 64116, United States
Kansas City Missouri, 64128, United States
Kansas City Missouri, 64131, United States
Kansas City Missouri, 64154, United States
Lee's Summit Missouri, 64064, United States
Saint Joseph Missouri, 64506, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63129, United States
Saint Louis Missouri, 63141, United States
Saint Peters Missouri, 63376, United States
Billings Montana, 59101, United States
Bozeman Montana, 59715, United States
Great Falls Montana, 59405, United States
Kalispell Montana, 59901, United States
Dover New Hampshire, 03820, United States
Lebanon New Hampshire, 03756, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87109, United States
Albuquerque New Mexico, 87109, United States
Las Cruces New Mexico, 88011, United States
Bay Shore New York, 11706, United States
Brooklyn New York, 11215, United States
Buffalo New York, 14263, United States
Cooperstown New York, 13326, United States
Elmira New York, 14905, United States
Lake Success New York, 11042, United States
New York New York, 10065, United States
White Plains New York, 10601, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Raleigh North Carolina, 27607, United States
Supply North Carolina, 28462, United States
Wilmington North Carolina, 28401, United States
Winston-Salem North Carolina, 27103, United States
Akron Ohio, 44307, United States
Beachwood Ohio, 44122, United States
Chardon Ohio, 44024, United States
Chillicothe Ohio, 45601, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Elyria Ohio, 44035, United States
Independence Ohio, 44131, United States
Mansfield Ohio, 44906, United States
Mayfield Heights Ohio, 44124, United States
Mentor Ohio, 44060, United States
Middleburg Heights Ohio, 44130, United States
Parma Ohio, 44129, United States
Sandusky Ohio, 44870, United States
Sandusky Ohio, 44870, United States
Strongsville Ohio, 44136, United States
Sylvania Ohio, 43560, United States
Westlake Ohio, 44145, United States
Wooster Ohio, 44691, United States
Oklahoma City Oklahoma, 73104, United States
Abington Pennsylvania, 19001, United States
Broomall Pennsylvania, 19008, United States
Chadds Ford Pennsylvania, 19317, United States
Danville Pennsylvania, 17822, United States
Dunmore Pennsylvania, 18512, United States
Glen Mills Pennsylvania, 19342, United States
Harrisburg Pennsylvania, 17109, United States
Philadelphia Pennsylvania, 19107, United States
Sayre Pennsylvania, 18840, United States
West Reading Pennsylvania, 19611, United States
Wilkes-Barre Pennsylvania, 18711, United States
Boiling Springs South Carolina, 29316, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29607, United States
Greenville South Carolina, 29615, United States
Greenwood South Carolina, 29646, United States
Greer South Carolina, 29651, United States
Hilton Head Island South Carolina, 29926, United States
Myrtle Beach South Carolina, 29577, United States
Seneca South Carolina, 29672, United States
Spartanburg South Carolina, 29303, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Galveston Texas, 77555, United States
League City Texas, 77573, United States
American Fork Utah, 84003, United States
Farmington Utah, 84025, United States
Logan Utah, 84321, United States
Murray Utah, 84107, United States
Ogden Utah, 84403, United States
Ogden Utah, 84405, United States
Provo Utah, 84604, United States
Riverton Utah, 84065, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84143, United States
South Jordan Utah, 84009, United States
Saint Johnsbury Vermont, 05819, United States
Fishersville Virginia, 22939, United States
Portsmouth Virginia, 23708, United States
Bellevue Washington, 98004, United States
Appleton Wisconsin, 54915, United States
Brookfield Wisconsin, 53045, United States
Eau Claire Wisconsin, 54703, United States
Franklin Wisconsin, 53132, United States
Grafton Wisconsin, 53024, United States
Green Bay Wisconsin, 54311, United States
Kenosha Wisconsin, 53142, United States
La Crosse Wisconsin, 54601, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53792, United States
Marinette Wisconsin, 54143, United States
Menomonee Falls Wisconsin, 53051, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53233, United States
Milwaukee Wisconsin, 53295, United States
Oshkosh Wisconsin, 54904, United States
Oshkosh Wisconsin, 54904, United States
Racine Wisconsin, 53405, United States
Sheboygan Wisconsin, 53081, United States
Summit Wisconsin, 53066, United States
Two Rivers Wisconsin, 54241, United States
West Allis Wisconsin, 53227, United States
West Bend Wisconsin, 53095, United States
Wisconsin Rapids Wisconsin, 54494, United States
Calgary Alberta, T2N 4, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 4, Canada
Chicoutimi Quebec, G7H 5, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H2X 3, Canada
Montreal Quebec, H3H 2, Canada
Quebec City Quebec, G1R 2, Canada
Sherbrooke Quebec, J1H 5, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Aarau , 5001, Switzerland
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