Prostate Cancer Clinical Trial
Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)
Summary
This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen receptor-pathway inhibitor therapy. The usual treatment for patients with metastatic prostate cancer is to receive hormonal medications including a medication to decrease testosterone levels in the body and a potent oral hormonal medication to block growth signals from male hormones (like testosterone) in the cancer cells. Patients whose cancer is responding exceptionally well to this therapy may take a break from these medications according to their doctor's guidance. This trial may help doctors determine if stopping treatment can allow for testosterone recovery.
Full Description
PRIMARY OBJECTIVE:
I. To determine the proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to >= 150 ng/ml) after treatment interruption.
SECONDARY OBJECTIVES:
I. To determine time to eugonadal testosterone (> 150 ng/dl). II. To determine duration off-treatment.
III. To assess changes in quality of life as follows:
To assess changes in patient-reported quality of life as assessed by the Functional Assessment of Cancer Therapy- Prostate (FACT-P) total score from baseline to 24 months after treatment interruption.
To assess changes in the FACT-P subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to 24 months after treatment interruption.
To assess changes in the FACT-P total score and subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to the remaining post-baseline time points (i.e., 6, 12, and 18 months) after treatment interruption.
OUTLINE:
Patients stop both hormonal medications (medication to decrease testosterone levels in the body and potent oral hormonal medication to block growth signals from male hormones in the cancer cells). Patients are then followed every 12 months for symptoms. Patients with an increase in prostate specific antigen (PSA) level to greater than or equal to 5 ng/ml, changes on imaging studies suggesting that their cancer is growing back, or symptoms that the doctor thinks is related to their cancer growing back, resume both hormonal treatments.
After completion of study treatment, patients are followed up every 6 months for 10 years from registration or withdrawal from the study or death.
Eligibility Criteria
Inclusion Criteria:
Histologic or clinical diagnosis of metastatic prostate cancer
Must have had evidence of metastatic disease by bone scan, or nodal or visceral lesions on computed tomography (CT) or magnetic resonance imaging (MRI) prior to starting on intense antiandrogen therapy (ADT)
Radiographic evidence of disease is not required at the time of enrollment
No metastases to liver or to brain, as these represent aggressive variant disease biology for which intermittent treatment may not be favored
Must currently be receiving intense ADT for metastatic hormone sensitive prostate cancer (mHSPC)
Testosterone suppression (TS) with luteinizing hormone releasing hormone (LHRH)-agonist or LHRH-antagonist AND
An approved secondary androgen receptor pathway inhibitor (ARPI) abiraterone, enzalutamide, or apalutamide (or darolutamide if approved for this indication)
Must have remained on testosterone suppression for metastatic disease continuously (without treatment breaks) for 540-750 days (approximately 18 to 24 months) from time of first dose of LHRH agonist or antagonist by time of registration. A period of anti-androgen treatment prior to LHRH agonist or antagonist initiation is not included in the 540 - 750 days (approximately 18 to 24 months)
Must have received treatment with ARPI for at least 360 days in total by time of A032101 registration. Treatment breaks from ARPI of up to 28 days are permitted (for example peri-procedural or for management of a temporary adverse event) as long as PSA did not rise while holding therapy
Prior TS in the context of neoadjuvant/concurrent/adjuvant treatment with local therapy is permitted. Prior course(s) of intermittent TS for biochemical-only recurrence is permitted. However, if the patient previously received TS, metastatic progression for which intense ADT was initiated must have occurred during an off-treatment interval and with testosterone >= 150 ng/dL
Prior local therapy for prostate cancer (either before or after diagnosis of metastatic disease) is permitted. Prior treatment with docetaxel chemotherapy for up to 6 cycles is permitted. Prior radiation therapy to metastatic sites (either for symptom palliation or for ablation of oligometastatic disease) is permitted
Exclusion Criteria:
No history of surgical castration
No history of ARPI use prior to diagnosis of mHSPC for which the patient is currently receiving intense ADT (such as in the neoadjuvant setting with prior local therapy)
No current or prior treatment with experimental agents for metastatic hormone-sensitive prostate cancer
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Prior to initiating intense ADT
Prostate specific antigen (PSA) >= 5 ng/ml
Testosterone >= 150 ng/dl. Patients are permitted to enroll if testosterone was not measured prior to initiating intense ADT for mHSPC if they did not previously receive TS and were not known or suspected to be hypogonadal at the time
At time of enrollment to A032101
PSA < 0.2 ng/ml
** PSA values (measured in the same laboratory) must be stable or falling for 3 consecutive measurements - i.e. any PSA rise must be followed by a decrease in PSA that is further decreased or stable on a 3rd measurement. Any patient with 2 consecutive rises in PSA values since achieving castrate level of testosterone is not eligible
Testosterone < 50 ng/dl
No current participation in a clinical study that does not allow for TS or ARPI interruption
No patients with a "currently active" second malignancy * Patients with non-melanomatous skin cancer, superficial bladder cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject
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There are 232 Locations for this study
Phoenix Arizona, 85004, United States More Info
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Fort Smith Arkansas, 72903, United States More Info
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Arroyo Grande California, 93420, United States More Info
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Carmichael California, 95608, United States More Info
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Carmichael California, 95608, United States More Info
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Dublin California, 94568, United States More Info
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Elk Grove California, 95758, United States More Info
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Emeryville California, 94608, United States More Info
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Emeryville California, 94608, United States More Info
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Martinez California, 94553, United States More Info
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Oakland California, 94609, United States More Info
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Rocklin California, 95765, United States More Info
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Sacramento California, 95816, United States More Info
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San Luis Obispo California, 93401, United States More Info
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Santa Maria California, 93444, United States More Info
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Walnut Creek California, 94597, United States
Woodland California, 95695, United States More Info
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Aurora Colorado, 80045, United States More Info
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Colorado Springs Colorado, 80907, United States More Info
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Colorado Springs Colorado, 80907, United States More Info
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Colorado Springs Colorado, 80923, United States More Info
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Denver Colorado, 80210, United States More Info
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Durango Colorado, 81301, United States More Info
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Durango Colorado, 81301, United States More Info
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Lakewood Colorado, 80228, United States More Info
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Littleton Colorado, 80122, United States More Info
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Longmont Colorado, 80501, United States More Info
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Parker Colorado, 80138, United States More Info
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Pueblo Colorado, 81004, United States More Info
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Aventura Florida, 33180, United States More Info
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Coral Gables Florida, 33146, United States More Info
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Deerfield Beach Florida, 33442, United States More Info
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Miami Florida, 33136, United States More Info
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Miami Florida, 33176, United States More Info
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Plantation Florida, 33324, United States More Info
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Alton Illinois, 62002, United States More Info
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Bloomington Illinois, 61704, United States More Info
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Canton Illinois, 61520, United States More Info
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Carbondale Illinois, 62902, United States More Info
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Carterville Illinois, 62918, United States More Info
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Carthage Illinois, 62321, United States More Info
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Centralia Illinois, 62801, United States More Info
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Centralia Illinois, 62801, United States More Info
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Chicago Illinois, 60611, United States More Info
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Chicago Illinois, 60637, United States More Info
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Decatur Illinois, 62526, United States More Info
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Decatur Illinois, 62526, United States More Info
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DeKalb Illinois, 60115, United States More Info
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Dixon Illinois, 61021, United States More Info
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Effingham Illinois, 62401, United States More Info
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Eureka Illinois, 61530, United States More Info
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Galesburg Illinois, 61401, United States More Info
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Galesburg Illinois, 61401, United States More Info
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Geneva Illinois, 60134, United States More Info
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Kewanee Illinois, 61443, United States More Info
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Lake Forest Illinois, 60045, United States More Info
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Macomb Illinois, 61455, United States More Info
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Mount Vernon Illinois, 62864, United States More Info
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New Lenox Illinois, 60451, United States More Info
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O'Fallon Illinois, 62269, United States More Info
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Orland Park Illinois, 60462, United States More Info
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Ottawa Illinois, 61350, United States More Info
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Pekin Illinois, 61554, United States More Info
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Pekin Illinois, 61554, United States More Info
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Peoria Illinois, 61615, United States More Info
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Peoria Illinois, 61615, United States More Info
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Peoria Illinois, 61636, United States More Info
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Peoria Illinois, 61637, United States More Info
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Peru Illinois, 61354, United States More Info
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Peru Illinois, 61354, United States More Info
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Princeton Illinois, 61356, United States More Info
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Springfield Illinois, 62702, United States More Info
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Springfield Illinois, 62702, United States More Info
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Springfield Illinois, 62781, United States More Info
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Warrenville Illinois, 60555, United States More Info
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Washington Illinois, 61571, United States More Info
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Ames Iowa, 50010, United States More Info
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Ames Iowa, 50010, United States More Info
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Boone Iowa, 50036, United States More Info
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Clive Iowa, 50325, United States
Clive Iowa, 50325, United States
Council Bluffs Iowa, 51503, United States More Info
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Creston Iowa, 50801, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Fort Dodge Iowa, 50501, United States More Info
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Jefferson Iowa, 50129, United States More Info
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Marshalltown Iowa, 50158, United States More Info
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West Des Moines Iowa, 50266, United States
Garden City Kansas, 67846, United States More Info
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Great Bend Kansas, 67530, United States More Info
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Bardstown Kentucky, 40004, United States More Info
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Corbin Kentucky, 40701, United States More Info
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Lexington Kentucky, 40504, United States More Info
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Lexington Kentucky, 40504, United States More Info
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Lexington Kentucky, 40509, United States More Info
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London Kentucky, 40741, United States More Info
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Mount Sterling Kentucky, 40353, United States More Info
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Boston Massachusetts, 02215, United States More Info
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Worcester Massachusetts, 01655, United States More Info
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Adrian Michigan, 49221, United States More Info
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Ann Arbor Michigan, 48106, United States More Info
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Brighton Michigan, 48114, United States More Info
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Brighton Michigan, 48114, United States More Info
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Canton Michigan, 48188, United States More Info
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Canton Michigan, 48188, United States More Info
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Caro Michigan, 48723, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Clarkston Michigan, 48346, United States More Info
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Clarkston Michigan, 48346, United States More Info
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Detroit Michigan, 48236, United States More Info
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East China Township Michigan, 48054, United States More Info
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Flint Michigan, 48503, United States More Info
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Flint Michigan, 48503, United States More Info
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Flint Michigan, 48503, United States More Info
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Flint Michigan, 48503, United States More Info
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Grosse Pointe Woods Michigan, 48236, United States More Info
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Grosse Pointe Woods Michigan, 48236, United States More Info
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Grosse Pointe Woods Michigan, 48236, United States More Info
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Lansing Michigan, 48912, United States More Info
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Livonia Michigan, 48154, United States More Info
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Macomb Michigan, 48044, United States More Info
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Macomb Michigan, 48044, United States More Info
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Marlette Michigan, 48453, United States More Info
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Monroe Michigan, 48162, United States More Info
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Pontiac Michigan, 48341, United States More Info
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Pontiac Michigan, 48341, United States More Info
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Pontiac Michigan, 48341, United States More Info
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Pontiac Michigan, 48341, United States More Info
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Saginaw Michigan, 48601, United States More Info
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Saginaw Michigan, 48604, United States More Info
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Sterling Heights Michigan, 48312, United States More Info
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Tawas City Michigan, 48764, United States More Info
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Warren Michigan, 48088, United States More Info
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Warren Michigan, 48093, United States More Info
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Warren Michigan, 48093, United States More Info
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Warren Michigan, 48093, United States More Info
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Warren Michigan, 48093, United States More Info
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West Branch Michigan, 48661, United States More Info
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Ypsilanti Michigan, 48106, United States More Info
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Ypsilanti Michigan, 48197, United States More Info
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Bemidji Minnesota, 56601, United States More Info
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Burnsville Minnesota, 55337, United States More Info
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Burnsville Minnesota, 55337, United States More Info
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Cambridge Minnesota, 55008, United States More Info
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Coon Rapids Minnesota, 55433, United States More Info
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Edina Minnesota, 55435, United States More Info
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Fridley Minnesota, 55432, United States More Info
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Maple Grove Minnesota, 55369, United States More Info
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Maplewood Minnesota, 55109, United States More Info
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Maplewood Minnesota, 55109, United States More Info
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Minneapolis Minnesota, 55407, United States More Info
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Minneapolis Minnesota, 55415, United States More Info
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Minneapolis Minnesota, 55454, United States More Info
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Monticello Minnesota, 55362, United States More Info
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New Ulm Minnesota, 56073, United States More Info
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Princeton Minnesota, 55371, United States More Info
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Robbinsdale Minnesota, 55422, United States More Info
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Saint Louis Park Minnesota, 55416, United States More Info
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Saint Paul Minnesota, 55101, United States More Info
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Saint Paul Minnesota, 55102, United States More Info
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Shakopee Minnesota, 55379, United States More Info
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Stillwater Minnesota, 55082, United States More Info
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Thief River Falls Minnesota, 56701, United States More Info
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Waconia Minnesota, 55387, United States More Info
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Willmar Minnesota, 56201, United States More Info
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Woodbury Minnesota, 55125, United States More Info
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Worthington Minnesota, 56187, United States More Info
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Wyoming Minnesota, 55092, United States More Info
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Ballwin Missouri, 63011, United States More Info
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Bolivar Missouri, 65613, United States More Info
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Branson Missouri, 65616, United States More Info
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Cape Girardeau Missouri, 63703, United States More Info
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Cape Girardeau Missouri, 63703, United States More Info
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Creve Coeur Missouri, 63141, United States More Info
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Farmington Missouri, 63640, United States More Info
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Jefferson City Missouri, 65109, United States More Info
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Joplin Missouri, 64804, United States More Info
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Joplin Missouri, 64804, United States More Info
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Rolla Missouri, 65401, United States More Info
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Rolla Missouri, 65401, United States More Info
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Saint Joseph Missouri, 64506, United States More Info
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Saint Louis Missouri, 63109, United States More Info
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Saint Louis Missouri, 63110, United States More Info
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Saint Louis Missouri, 63128, United States More Info
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Saint Louis Missouri, 63129, United States More Info
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Saint Louis Missouri, 63131, United States More Info
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Saint Louis Missouri, 63136, United States More Info
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Saint Louis Missouri, 63141, United States More Info
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Saint Peters Missouri, 63376, United States More Info
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Sainte Genevieve Missouri, 63670, United States More Info
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Springfield Missouri, 65804, United States More Info
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Springfield Missouri, 65807, United States More Info
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Sullivan Missouri, 63080, United States More Info
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Sunset Hills Missouri, 63127, United States More Info
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Washington Missouri, 63090, United States More Info
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Grand Island Nebraska, 68803, United States
Kearney Nebraska, 68847, United States More Info
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Lincoln Nebraska, 68510, United States More Info
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Omaha Nebraska, 68122, United States More Info
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Omaha Nebraska, 68124, United States More Info
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Omaha Nebraska, 68130, United States More Info
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Omaha Nebraska, 68131, United States More Info
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Papillion Nebraska, 68046, United States More Info
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Basking Ridge New Jersey, 07920, United States More Info
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Lakewood New Jersey, 08701, United States More Info
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Livingston New Jersey, 07039, United States More Info
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Long Branch New Jersey, 07740, United States More Info
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Middletown New Jersey, 07748, United States More Info
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Montvale New Jersey, 07645, United States More Info
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New Brunswick New Jersey, 08903, United States More Info
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Toms River New Jersey, 08755, United States More Info
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Commack New York, 11725, United States More Info
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Harrison New York, 10604, United States More Info
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Middletown New York, 10940, United States More Info
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New York New York, 10065, United States More Info
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Uniondale New York, 11553, United States More Info
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Hendersonville North Carolina, 28791, United States More Info
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Bismarck North Dakota, 58501, United States More Info
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Fargo North Dakota, 58103, United States More Info
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Fargo North Dakota, 58103, United States More Info
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Fargo North Dakota, 58104, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Beavercreek Ohio, 45431, United States More Info
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Boardman Ohio, 44512, United States More Info
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Centerville Ohio, 45459, United States More Info
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Centerville Ohio, 45459, United States More Info
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Cincinnati Ohio, 45220, United States More Info
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Cincinnati Ohio, 45236, United States More Info
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Cincinnati Ohio, 45242, United States More Info
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Cincinnati Ohio, 45247, United States More Info
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Cincinnati Ohio, 45255, United States More Info
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Dayton Ohio, 45409, United States More Info
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Dayton Ohio, 45409, United States More Info
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Dayton Ohio, 45415, United States More Info
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Dayton Ohio, 45415, United States More Info
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Findlay Ohio, 45840, United States More Info
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Findlay Ohio, 45840, United States More Info
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Findlay Ohio, 45840, United States More Info
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Franklin Ohio, 45005, United States More Info
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Franklin Ohio, 45005, United States More Info
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Greenville Ohio, 45331, United States More Info
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Greenville Ohio, 45331, United States More Info
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Kettering Ohio, 45409, United States More Info
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Kettering Ohio, 45429, United States More Info
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Maumee Ohio, 43537, United States More Info
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Toledo Ohio, 43623, United States More Info
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Troy Ohio, 45373, United States More Info
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Troy Ohio, 45373, United States More Info
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Warren Ohio, 44484, United States More Info
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Youngstown Ohio, 44501, United States More Info
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Lawton Oklahoma, 73505, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Oklahoma City Oklahoma, 73120, United States More Info
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Allentown Pennsylvania, 18103, United States More Info
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Bethlehem Pennsylvania, 18017, United States More Info
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East Stroudsburg Pennsylvania, 18301, United States More Info
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Hazleton Pennsylvania, 18201, United States More Info
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Sioux Falls South Dakota, 57104, United States More Info
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Sioux Falls South Dakota, 57117, United States More Info
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Bryan Texas, 77802, United States
Martinsville Virginia, 24115, United States
Bremerton Washington, 98310, United States
Burien Washington, 98166, United States
Enumclaw Washington, 98022, United States
Federal Way Washington, 98003, United States
Lakewood Washington, 98499, United States
Tacoma Washington, 98405, United States
Eau Claire Wisconsin, 54701, United States More Info
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Marshfield Wisconsin, 54449, United States More Info
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Menomonee Falls Wisconsin, 53051, United States More Info
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Milwaukee Wisconsin, 53226, United States More Info
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Minocqua Wisconsin, 54548, United States More Info
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New Richmond Wisconsin, 54017, United States More Info
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Oak Creek Wisconsin, 53154, United States More Info
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Rice Lake Wisconsin, 54868, United States More Info
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Stevens Point Wisconsin, 54482, United States More Info
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West Bend Wisconsin, 53095, United States More Info
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Weston Wisconsin, 54476, United States More Info
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