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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-02356 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| S2210 | Other Identifier | SWOG | |
| S2210 | Other Identifier | CTEP | |
| U10CA180888 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping, or slowing the growth of tumor cells. Giving carboplatin before surgery may shrink tumors in patients with high-risk prostate cancer with BRCA1 and BRCA2 gene mutations.
PRIMARY OBJECTIVE:
I. To evaluate the pathologic complete response rate at prostatectomy in patients with localized high-risk prostate cancer with germline BRCA2 or BRCA1 mutations who are treated with neoadjuvant carboplatin by central review of source documents.
SECONDARY OBJECTIVES:
I. To evaluate prostate specific antigen (PSA) progression-free survival post-prostatectomy over the duration of follow-up and specifically, at the 3-year landmark.
II. To evaluate metastases free survival and overall survival. III. To evaluate the frequency and severity of toxicities of neoadjuvant carboplatin followed by radical prostatectomy.
BANKING OBJECTIVE:
I. To bank specimens for future correlative studies.
OUTLINE:
Patients receive carboplatin intravenously (IV) on study. Patients then undergo surgery on study. Patients who experience PSA progression after surgery undergo computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis, CT of the chest or chest X-ray, or prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) throughout the trial. Patients also undergo collection of blood samples throughout the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (carboplatin) | Experimental | Patients receive carboplatin IV on study. Patients then undergo surgery on study. Patients who experience PSA progression after surgery undergo CT or MRI of the abdomen and pelvis, CT of the chest or chest X-ray, or PSMA-PET throughout the trial. Patients also undergo collection of blood samples throughout the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response after neoadjuvant carboplatin | A two-stage design will be used. | Up to 5 years |
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Inclusion Criteria:
Participant must have histologic diagnosis of prostate adenocarcinoma
Participant must have high or very high-risk disease defined by at least one of the following:
Participant must have documented evidence of germline mutation (pathogenic/likely pathogenic variant) in BRCA2 or BRCA1 through testing in a Clinical Laboratory Improvement Act (CLIA)-certified lab
Participant may have initiated gonadotrophin releasing hormone (gnRH) agonist, gnRH antagonist, oral anti-androgen (e.g. bicalutamide, nilutamide, flutamide), or other agent intended to treat prostate cancer prior to registration. The effectiveness of the current depot of such treatment must not extend beyond 1 month after study registration. Agents listed above cannot be started after participant registration
Participant must be >= 18 years old
Participant must have Zubrod performance status of 0-2
Participant must have a complete medical history and physical exam within 28 days prior to registration
Absolute neutrophil count >= 1.5 x 10^3/uL (within 28 days prior to registration)
Platelets >= 100 x 10^3/uL (within 28 days prior to registration)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN) (within 28 days prior to registration)
Participant must have a serum creatinine =< the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
Participant must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification within 28 days prior to registration. To be eligible for this trial, participants must be class 2B or better
Participant with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test within 6 months prior to registration
Participant with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within in 28 days prior to registration
Participant with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 28 days prior to registration
Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including vasectomy with testing showing no sperm in the semen
Prior to registration, participant must have had a urologic consult and be deemed a surgical candidate with known sites of disease deemed by the urologist to be potentially resectable
Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Exclusion Criteria:
Participant must not have evidence of distant metastatic disease by conventional imaging within 90 days prior to registration
Participant must not have received prior radiation therapy (RT) to the pelvic region
Participant must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of protocol treatment
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| Name | Affiliation | Role |
|---|---|---|
| Heather H Cheng | SWOG Cancer Research Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchorage Associates in Radiation Medicine | Recruiting | Anchorage | Alaska | 98508 | United States |
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| Carboplatin | Drug | Given IV |
|
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| Chest Radiography | Procedure | Undergo chest X-ray |
|
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| Computed Tomography | Procedure | Undergo CT |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
|
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| PSMA PET Scan | Procedure | Undergo PSMA PET |
|
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| Surgical Procedure | Procedure | Undergo surgery |
|
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| Anchorage Radiation Therapy Center | Recruiting | Anchorage | Alaska | 99504 | United States |
|
| Alaska Breast Care and Surgery LLC | Recruiting | Anchorage | Alaska | 99508 | United States |
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| Alaska Oncology and Hematology LLC | Recruiting | Anchorage | Alaska | 99508 | United States |
|
| Alaska Women's Cancer Care | Recruiting | Anchorage | Alaska | 99508 | United States |
|
| Anchorage Oncology Centre | Recruiting | Anchorage | Alaska | 99508 | United States |
|
| Katmai Oncology Group | Recruiting | Anchorage | Alaska | 99508 | United States |
|
| Providence Alaska Medical Center | Recruiting | Anchorage | Alaska | 99508 | United States |
|
| Cancer Center at Saint Joseph's | Recruiting | Phoenix | Arizona | 85004 | United States |
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| Mission Hope Medical Oncology - Arroyo Grande | Recruiting | Arroyo Grande | California | 93420 | United States |
|
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Recruiting | Burbank | California | 91505 | United States |
|
| Mercy Cancer Center �� Carmichael | Recruiting | Carmichael | California | 95608 | United States |
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| Mercy San Juan Medical Center | Recruiting | Carmichael | California | 95608 | United States |
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| City of Hope Comprehensive Cancer Center | Recruiting | Duarte | California | 91010 | United States |
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| Mercy Cancer Center - Elk Grove | Recruiting | Elk Grove | California | 95758 | United States |
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| City of Hope at Irvine Lennar | Recruiting | Irvine | California | 92618 | United States |
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| Providence Queen of The Valley | Recruiting | Napa | California | 94558 | United States |
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| Mercy Cancer Center - Rocklin | Recruiting | Rocklin | California | 95765 | United States |
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| Mercy Cancer Center - Sacramento | Recruiting | Sacramento | California | 95816 | United States |
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| Pacific Central Coast Health Center-San Luis Obispo | Recruiting | San Luis Obispo | California | 93401 | United States |
|
| Mission Hope Medical Oncology - Santa Maria | Recruiting | Santa Maria | California | 93444 | United States |
|
| Providence Medical Foundation - Santa Rosa | Recruiting | Santa Rosa | California | 95403 | United States |
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| Providence Santa Rosa Memorial Hospital | Recruiting | Santa Rosa | California | 95405 | United States |
|
| Woodland Memorial Hospital | Recruiting | Woodland | California | 95695 | United States |
|
| Penrose-Saint Francis Healthcare | Recruiting | Colorado Springs | Colorado | 80907 | United States |
|
| Rocky Mountain Cancer Centers-Penrose | Recruiting | Colorado Springs | Colorado | 80907 | United States |
|
| Saint Francis Cancer Center | Recruiting | Colorado Springs | Colorado | 80923 | United States |
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| Porter Adventist Hospital | Recruiting | Denver | Colorado | 80210 | United States |
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| Mercy Medical Center | Recruiting | Durango | Colorado | 81301 | United States |
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| Southwest Oncology PC | Recruiting | Durango | Colorado | 81301 | United States |
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| Saint Anthony Hospital | Recruiting | Lakewood | Colorado | 80228 | United States |
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| Littleton Adventist Hospital | Recruiting | Littleton | Colorado | 80122 | United States |
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| Longmont United Hospital | Recruiting | Longmont | Colorado | 80501 | United States |
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| Parker Adventist Hospital | Recruiting | Parker | Colorado | 80138 | United States |
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| Saint Mary Corwin Medical Center | Recruiting | Pueblo | Colorado | 81004 | United States |
|
| Smilow Cancer Hospital-Derby Care Center | Recruiting | Derby | Connecticut | 06418 | United States |
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| Smilow Cancer Hospital Care Center-Fairfield | Recruiting | Fairfield | Connecticut | 06824 | United States |
|
| Smilow Cancer Hospital Care Center at Glastonbury | Recruiting | Glastonbury | Connecticut | 06033 | United States |
|
| Smilow Cancer Hospital Care Center at Greenwich | Recruiting | Greenwich | Connecticut | 06830 | United States |
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| Smilow Cancer Hospital Care Center - Guilford | Recruiting | Guilford | Connecticut | 06437 | United States |
|
| Smilow Cancer Hospital Care Center at Saint Francis | Recruiting | Hartford | Connecticut | 06105 | United States |
|
| Smilow Cancer Center/Yale-New Haven Hospital | Recruiting | New Haven | Connecticut | 06510 | United States |
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| Yale University | Recruiting | New Haven | Connecticut | 06520 | United States |
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| Yale-New Haven Hospital North Haven Medical Center | Recruiting | North Haven | Connecticut | 06473 | United States |
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| Smilow Cancer Hospital Care Center at Long Ridge | Recruiting | Stamford | Connecticut | 06902 | United States |
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| Smilow Cancer Hospital-Torrington Care Center | Recruiting | Torrington | Connecticut | 06790 | United States |
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| Smilow Cancer Hospital Care Center-Trumbull | Recruiting | Trumbull | Connecticut | 06611 | United States |
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| Smilow Cancer Hospital-Waterbury Care Center | Recruiting | Waterbury | Connecticut | 06708 | United States |
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| Smilow Cancer Hospital Care Center - Waterford | Recruiting | Waterford | Connecticut | 06385 | United States |
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| Saint Alphonsus Cancer Care Center-Boise | Recruiting | Boise | Idaho | 83706 | United States |
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| Saint Luke's Cancer Institute - Boise | Recruiting | Boise | Idaho | 83712 | United States |
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| Saint Alphonsus Cancer Care Center-Caldwell | Recruiting | Caldwell | Idaho | 83605 | United States |
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| Kootenai Health - Coeur d'Alene | Recruiting | Coeur d'Alene | Idaho | 83814 | United States |
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| Walter Knox Memorial Hospital | Recruiting | Emmett | Idaho | 83617 | United States |
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| Saint Luke's Cancer Institute - Fruitland | Recruiting | Fruitland | Idaho | 83619 | United States |
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| Idaho Urologic Institute-Meridian | Recruiting | Meridian | Idaho | 83642 | United States |
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| Saint Luke's Cancer Institute - Meridian | Recruiting | Meridian | Idaho | 83642 | United States |
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| Saint Luke's Cancer Institute - Nampa | Recruiting | Nampa | Idaho | 83686 | United States |
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| Saint Alphonsus Cancer Care Center-Nampa | Recruiting | Nampa | Idaho | 83687 | United States |
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| Kootenai Clinic Cancer Services - Post Falls | Recruiting | Post Falls | Idaho | 83854 | United States |
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| Kootenai Cancer Clinic | Recruiting | Sandpoint | Idaho | 83864 | United States |
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| Saint Luke's Cancer Institute - Twin Falls | Recruiting | Twin Falls | Idaho | 83301 | United States |
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| NorthShore University HealthSystem-Evanston Hospital | Recruiting | Evanston | Illinois | 60201 | United States |
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| NorthShore University HealthSystem-Glenbrook Hospital | Recruiting | Glenview | Illinois | 60026 | United States |
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| NorthShore University HealthSystem-Highland Park Hospital | Recruiting | Highland Park | Illinois | 60035 | United States |
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| North Shore Medical Center | Recruiting | Skokie | Illinois | 60076 | United States |
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| Alegent Health Mercy Hospital | Recruiting | Council Bluffs | Iowa | 51503 | United States |
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| Flaget Memorial Hospital | Recruiting | Bardstown | Kentucky | 40004 | United States |
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| Commonwealth Cancer Center-Corbin | Recruiting | Corbin | Kentucky | 40701 | United States |
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| Saint Joseph Hospital | Recruiting | Lexington | Kentucky | 40504 | United States |
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| Saint Joseph Radiation Oncology Resource Center | Recruiting | Lexington | Kentucky | 40504 | United States |
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| Saint Joseph Hospital East | Recruiting | Lexington | Kentucky | 40509 | United States |
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| Saint Joseph London | Recruiting | London | Kentucky | 40741 | United States |
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| Saint Joseph Mount Sterling | Recruiting | Mount Sterling | Kentucky | 40353 | United States |
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| LSU Healthcare Network / Metairie Multi-Specialty Clinic | Recruiting | Metairie | Louisiana | 70006 | United States |
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| Louisiana State University Health Science Center | Recruiting | New Orleans | Louisiana | 70112 | United States |
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| Community Hospital of Anaconda | Recruiting | Anaconda | Montana | 59711 | United States |
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| Billings Clinic Cancer Center | Recruiting | Billings | Montana | 59101 | United States |
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| Bozeman Deaconess Hospital | Recruiting | Bozeman | Montana | 59715 | United States |
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| Benefis Healthcare- Sletten Cancer Institute | Recruiting | Great Falls | Montana | 59405 | United States |
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| Great Falls Clinic | Recruiting | Great Falls | Montana | 59405 | United States |
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| Kalispell Regional Medical Center | Recruiting | Kalispell | Montana | 59901 | United States |
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| Saint Patrick Hospital - Community Hospital | Recruiting | Missoula | Montana | 59802 | United States |
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| Community Medical Hospital | Suspended | Missoula | Montana | 59804 | United States |
| CHI Health Good Samaritan | Recruiting | Kearney | Nebraska | 68847 | United States |
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| Saint Elizabeth Regional Medical Center | Recruiting | Lincoln | Nebraska | 68510 | United States |
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| Alegent Health Immanuel Medical Center | Recruiting | Omaha | Nebraska | 68122 | United States |
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| Alegent Health Bergan Mercy Medical Center | Recruiting | Omaha | Nebraska | 68124 | United States |
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| Alegent Health Lakeside Hospital | Recruiting | Omaha | Nebraska | 68130 | United States |
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| Creighton University Medical Center | Recruiting | Omaha | Nebraska | 68131 | United States |
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| Midlands Community Hospital | Recruiting | Papillion | Nebraska | 68046 | United States |
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| Garnet Health Medical Center | Recruiting | Middletown | New York | 10940 | United States |
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| Good Samaritan Hospital - Cincinnati | Recruiting | Cincinnati | Ohio | 45220 | United States |
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| Bethesda North Hospital | Recruiting | Cincinnati | Ohio | 45242 | United States |
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| TriHealth Cancer Institute-Westside | Recruiting | Cincinnati | Ohio | 45247 | United States |
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| TriHealth Cancer Institute-Anderson | Recruiting | Cincinnati | Ohio | 45255 | United States |
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| University of Oklahoma Health Sciences Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Saint Alphonsus Medical Center-Baker City | Recruiting | Baker City | Oregon | 97814 | United States |
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| Saint Charles Health System | Recruiting | Bend | Oregon | 97701 | United States |
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| Clackamas Radiation Oncology Center | Recruiting | Clackamas | Oregon | 97015 | United States |
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| Providence Cancer Institute Clackamas Clinic | Recruiting | Clackamas | Oregon | 97015 | United States |
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| Bay Area Hospital | Recruiting | Coos Bay | Oregon | 97420 | United States |
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| Providence Newberg Medical Center | Recruiting | Newberg | Oregon | 97132 | United States |
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| Saint Alphonsus Medical Center-Ontario | Recruiting | Ontario | Oregon | 97914 | United States |
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| Providence Willamette Falls Medical Center | Recruiting | Oregon City | Oregon | 97045 | United States |
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| Providence Portland Medical Center | Recruiting | Portland | Oregon | 97213 | United States |
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| Providence Saint Vincent Medical Center | Recruiting | Portland | Oregon | 97225 | United States |
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| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| Saint Charles Health System-Redmond | Recruiting | Redmond | Oregon | 97756 | United States |
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| Smilow Cancer Hospital Care Center - Westerly | Recruiting | Westerly | Rhode Island | 02891 | United States |
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| Providence Regional Cancer System-Aberdeen | Recruiting | Aberdeen | Washington | 98520 | United States |
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| PeaceHealth Saint Joseph Medical Center | Recruiting | Bellingham | Washington | 98225 | United States |
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| Harrison Medical Center | Recruiting | Bremerton | Washington | 98310 | United States |
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| Providence Regional Cancer System-Centralia | Recruiting | Centralia | Washington | 98531 | United States |
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| Swedish Cancer Institute-Edmonds | Recruiting | Edmonds | Washington | 98026 | United States |
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| Providence Regional Cancer Partnership | Recruiting | Everett | Washington | 98201 | United States |
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| Swedish Cancer Institute-Issaquah | Recruiting | Issaquah | Washington | 98029 | United States |
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| Kadlec Clinic Hematology and Oncology | Recruiting | Kennewick | Washington | 99336 | United States |
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| Providence Regional Cancer System-Lacey | Recruiting | Lacey | Washington | 98503 | United States |
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| PeaceHealth Saint John Medical Center | Recruiting | Longview | Washington | 98632 | United States |
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| Swedish Medical Center-Ballard Campus | Recruiting | Seattle | Washington | 98107 | United States |
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| FHCC South Lake Union | Recruiting | Seattle | Washington | 98109 | United States |
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| Fred Hutchinson Cancer Research Center | Recruiting | Seattle | Washington | 98109 | United States |
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| Swedish Medical Center-Cherry Hill | Recruiting | Seattle | Washington | 98122-5711 | United States |
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| Swedish Medical Center-First Hill | Recruiting | Seattle | Washington | 98122 | United States |
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| University of Washington Medical Center - Montlake | Recruiting | Seattle | Washington | 98195 | United States |
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| PeaceHealth United General Medical Center | Recruiting | Sedro-Woolley | Washington | 98284 | United States |
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| Providence Regional Cancer System-Shelton | Recruiting | Shelton | Washington | 98584 | United States |
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| PeaceHealth Southwest Medical Center | Recruiting | Vancouver | Washington | 98664 | United States |
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| Providence Saint Mary Regional Cancer Center | Recruiting | Walla Walla | Washington | 99362 | United States |
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| Providence Regional Cancer System-Yelm | Recruiting | Yelm | Washington | 98597 | United States |
|
| Billings Clinic-Cody | Recruiting | Cody | Wyoming | 82414 | United States |
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| Welch Cancer Center | Recruiting | Sheridan | Wyoming | 82801 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D016190 | Carboplatin |
| D014965 | X-Rays |
| D009682 | Magnetic Resonance Spectroscopy |
| D043425 | Glutamate Carboxypeptidase II |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D002268 | Carboxypeptidases |
| D020689 | Exopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045727 | Metalloexopeptidases |
| D045726 | Metalloproteases |
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