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Could a chemo drug shrink prostate tumors in men with BRCA mutations?

NCT ID NCT05806515

Disease control Sponsor: SWOG Cancer Research Network Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for men with high-risk prostate cancer who have inherited BRCA1 or BRCA2 gene mutations. It tests whether giving the chemotherapy drug carboplatin before surgery can shrink tumors more effectively. About 44 participants will receive carboplatin, and researchers will check if the cancer disappears completely after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * cT3a - cT4x * Grade group 4 or 5 (Gleason sum 8-10) * PSA \> 20 ng/mL prior to registration * 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 * NOTE: Local lab report is sufficient for eligibility * 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 * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations * As part of the 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 * NOTE: cN1 detected only by PSMA-PET is permitted if urologist deems sites of disease to be potentially completely resectable * 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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Get notified about this study

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate adenocarcinoma Stage IIIB prostate cancer ajcc V8 Stage IIIC prostate cancer ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    133 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alaska Breast Care and Surgery LLC

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Alaska Oncology and Hematology LLC

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Alaska Women's Cancer Care

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Alegent Health Bergan Mercy Medical Center

    RECRUITING

    Omaha, Nebraska, 68124, United States

    Contact Email: •••••@•••••

  • Alegent Health Immanuel Medical Center

    RECRUITING

    Omaha, Nebraska, 68122, United States

    Contact Email: •••••@•••••

  • Alegent Health Lakeside Hospital

    RECRUITING

    Omaha, Nebraska, 68130, United States

    Contact Email: •••••@•••••

  • Alegent Health Mercy Hospital

    RECRUITING

    Council Bluffs, Iowa, 51503, United States

    Contact Email: •••••@•••••

  • Anchorage Associates in Radiation Medicine

    RECRUITING

    Anchorage, Alaska, 98508, United States

  • Anchorage Oncology Centre

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Anchorage Radiation Therapy Center

    RECRUITING

    Anchorage, Alaska, 99504, United States

  • Bay Area Hospital

    RECRUITING

    Coos Bay, Oregon, 97420, United States

  • Benefis Healthcare- Sletten Cancer Institute

    RECRUITING

    Great Falls, Montana, 59405, United States

    Contact Email: •••••@•••••

  • Bethesda North Hospital

    RECRUITING

    Cincinnati, Ohio, 45242, United States

    Contact Email: •••••@•••••

  • Billings Clinic Cancer Center

    RECRUITING

    Billings, Montana, 59101, United States

    Contact Email: •••••@•••••

  • Billings Clinic-Cody

    RECRUITING

    Cody, Wyoming, 82414, United States

    Contact Email: •••••@•••••

  • Bozeman Deaconess Hospital

    RECRUITING

    Bozeman, Montana, 59715, United States

    Contact Email: •••••@•••••

  • CHI Health Good Samaritan

    RECRUITING

    Kearney, Nebraska, 68847, United States

    Contact Email: •••••@•••••

  • Cancer Center at Saint Joseph's

    RECRUITING

    Phoenix, Arizona, 85004, United States

    Contact Email: •••••@•••••

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • City of Hope at Irvine Lennar

    RECRUITING

    Irvine, California, 92618, United States

  • Clackamas Radiation Oncology Center

    RECRUITING

    Clackamas, Oregon, 97015, United States

    Contact Email: •••••@•••••

  • Commonwealth Cancer Center-Corbin

    RECRUITING

    Corbin, Kentucky, 40701, United States

    Contact Email: •••••@•••••

  • Community Hospital of Anaconda

    RECRUITING

    Anaconda, Montana, 59711, United States

    Contact Email: •••••@•••••

  • Community Medical Hospital

    SUSPENDED

    Missoula, Montana, 59804, United States

  • Creighton University Medical Center

    RECRUITING

    Omaha, Nebraska, 68131, United States

    Contact Email: •••••@•••••

  • FHCC South Lake Union

    RECRUITING

    Seattle, Washington, 98109, United States

  • Flaget Memorial Hospital

    RECRUITING

    Bardstown, Kentucky, 40004, United States

    Contact Email: •••••@•••••

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Garnet Health Medical Center

    RECRUITING

    Middletown, New York, 10940, United States

  • Good Samaritan Hospital - Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45220, United States

    Contact Email: •••••@•••••

  • Great Falls Clinic

    RECRUITING

    Great Falls, Montana, 59405, United States

    Contact Email: •••••@•••••

  • Harrison Medical Center

    RECRUITING

    Bremerton, Washington, 98310, United States

    Contact Email: •••••@•••••

  • Idaho Urologic Institute-Meridian

    RECRUITING

    Meridian, Idaho, 83642, United States

  • Kadlec Clinic Hematology and Oncology

    RECRUITING

    Kennewick, Washington, 99336, United States

    Contact Email: •••••@•••••

  • Kalispell Regional Medical Center

    RECRUITING

    Kalispell, Montana, 59901, United States

    Contact Email: •••••@•••••

  • Katmai Oncology Group

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Kootenai Cancer Clinic

    RECRUITING

    Sandpoint, Idaho, 83864, United States

    Contact Email: •••••@•••••

  • Kootenai Clinic Cancer Services - Post Falls

    RECRUITING

    Post Falls, Idaho, 83854, United States

    Contact Email: •••••@•••••

  • Kootenai Health - Coeur d'Alene

    RECRUITING

    Coeur d'Alene, Idaho, 83814, United States

    Contact Email: •••••@•••••

  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Littleton Adventist Hospital

    RECRUITING

    Littleton, Colorado, 80122, United States

    Contact Email: •••••@•••••

  • Longmont United Hospital

    RECRUITING

    Longmont, Colorado, 80501, United States

    Contact Email: •••••@•••••

  • Louisiana State University Health Science Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Mercy Cancer Center - Elk Grove

    RECRUITING

    Elk Grove, California, 95758, United States

    Contact Email: •••••@•••••

  • Mercy Cancer Center - Rocklin

    RECRUITING

    Rocklin, California, 95765, United States

    Contact Email: •••••@•••••

  • Mercy Cancer Center - Sacramento

    RECRUITING

    Sacramento, California, 95816, United States

    Contact Email: •••••@•••••

  • Mercy Cancer Center �� Carmichael

    RECRUITING

    Carmichael, California, 95608, United States

  • Mercy Medical Center

    RECRUITING

    Durango, Colorado, 81301, United States

    Contact Email: •••••@•••••

  • Mercy San Juan Medical Center

    RECRUITING

    Carmichael, California, 95608, United States

    Contact Email: •••••@•••••

  • Midlands Community Hospital

    RECRUITING

    Papillion, Nebraska, 68046, United States

    Contact Email: •••••@•••••

  • Mission Hope Medical Oncology - Arroyo Grande

    RECRUITING

    Arroyo Grande, California, 93420, United States

    Contact Email: •••••@•••••

  • Mission Hope Medical Oncology - Santa Maria

    RECRUITING

    Santa Maria, California, 93444, United States

    Contact Email: •••••@•••••

  • North Shore Medical Center

    RECRUITING

    Skokie, Illinois, 60076, United States

  • NorthShore University HealthSystem-Evanston Hospital

    RECRUITING

    Evanston, Illinois, 60201, United States

  • NorthShore University HealthSystem-Glenbrook Hospital

    RECRUITING

    Glenview, Illinois, 60026, United States

  • NorthShore University HealthSystem-Highland Park Hospital

    RECRUITING

    Highland Park, Illinois, 60035, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Pacific Central Coast Health Center-San Luis Obispo

    RECRUITING

    San Luis Obispo, California, 93401, United States

    Contact Email: •••••@•••••

  • Parker Adventist Hospital

    RECRUITING

    Parker, Colorado, 80138, United States

    Contact Email: •••••@•••••

  • PeaceHealth Saint John Medical Center

    RECRUITING

    Longview, Washington, 98632, United States

  • PeaceHealth Saint Joseph Medical Center

    RECRUITING

    Bellingham, Washington, 98225, United States

  • PeaceHealth Southwest Medical Center

    RECRUITING

    Vancouver, Washington, 98664, United States

  • PeaceHealth United General Medical Center

    RECRUITING

    Sedro-Woolley, Washington, 98284, United States

  • Penrose-Saint Francis Healthcare

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

    Contact Email: •••••@•••••

  • Porter Adventist Hospital

    RECRUITING

    Denver, Colorado, 80210, United States

    Contact Email: •••••@•••••

  • Providence Alaska Medical Center

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Providence Cancer Institute Clackamas Clinic

    RECRUITING

    Clackamas, Oregon, 97015, United States

    Contact Email: •••••@•••••

  • Providence Medical Foundation - Santa Rosa

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Providence Newberg Medical Center

    RECRUITING

    Newberg, Oregon, 97132, United States

    Contact Email: •••••@•••••

  • Providence Portland Medical Center

    RECRUITING

    Portland, Oregon, 97213, United States

    Contact Email: •••••@•••••

  • Providence Queen of The Valley

    RECRUITING

    Napa, California, 94558, United States

  • Providence Regional Cancer Partnership

    RECRUITING

    Everett, Washington, 98201, United States

  • Providence Regional Cancer System-Aberdeen

    RECRUITING

    Aberdeen, Washington, 98520, United States

  • Providence Regional Cancer System-Centralia

    RECRUITING

    Centralia, Washington, 98531, United States

  • Providence Regional Cancer System-Lacey

    RECRUITING

    Lacey, Washington, 98503, United States

  • Providence Regional Cancer System-Shelton

    RECRUITING

    Shelton, Washington, 98584, United States

  • Providence Regional Cancer System-Yelm

    RECRUITING

    Yelm, Washington, 98597, United States

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    RECRUITING

    Burbank, California, 91505, United States

  • Providence Saint Mary Regional Cancer Center

    RECRUITING

    Walla Walla, Washington, 99362, United States

  • Providence Saint Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

    Contact Email: •••••@•••••

  • Providence Santa Rosa Memorial Hospital

    RECRUITING

    Santa Rosa, California, 95405, United States

  • Providence Willamette Falls Medical Center

    RECRUITING

    Oregon City, Oregon, 97045, United States

    Contact Email: •••••@•••••

  • Rocky Mountain Cancer Centers-Penrose

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

    Contact Email: •••••@•••••

  • Saint Alphonsus Cancer Care Center-Boise

    RECRUITING

    Boise, Idaho, 83706, United States

  • Saint Alphonsus Cancer Care Center-Caldwell

    RECRUITING

    Caldwell, Idaho, 83605, United States

  • Saint Alphonsus Cancer Care Center-Nampa

    RECRUITING

    Nampa, Idaho, 83687, United States

    Contact Email: •••••@•••••

  • Saint Alphonsus Medical Center-Baker City

    RECRUITING

    Baker City, Oregon, 97814, United States

    Contact Email: •••••@•••••

  • Saint Alphonsus Medical Center-Ontario

    RECRUITING

    Ontario, Oregon, 97914, United States

    Contact Email: •••••@•••••

  • Saint Anthony Hospital

    RECRUITING

    Lakewood, Colorado, 80228, United States

    Contact Email: •••••@•••••

  • Saint Charles Health System

    RECRUITING

    Bend, Oregon, 97701, United States

  • Saint Charles Health System-Redmond

    RECRUITING

    Redmond, Oregon, 97756, United States

  • Saint Elizabeth Regional Medical Center

    RECRUITING

    Lincoln, Nebraska, 68510, United States

    Contact Email: •••••@•••••

  • Saint Francis Cancer Center

    RECRUITING

    Colorado Springs, Colorado, 80923, United States

    Contact Email: •••••@•••••

  • Saint Joseph Hospital

    RECRUITING

    Lexington, Kentucky, 40504, United States

  • Saint Joseph Hospital East

    RECRUITING

    Lexington, Kentucky, 40509, United States

    Contact Email: •••••@•••••

  • Saint Joseph London

    RECRUITING

    London, Kentucky, 40741, United States

    Contact Email: •••••@•••••

  • Saint Joseph Mount Sterling

    RECRUITING

    Mount Sterling, Kentucky, 40353, United States

  • Saint Joseph Radiation Oncology Resource Center

    RECRUITING

    Lexington, Kentucky, 40504, United States

    Contact Email: •••••@•••••

  • Saint Luke's Cancer Institute - Boise

    RECRUITING

    Boise, Idaho, 83712, United States

  • Saint Luke's Cancer Institute - Fruitland

    RECRUITING

    Fruitland, Idaho, 83619, United States

  • Saint Luke's Cancer Institute - Meridian

    RECRUITING

    Meridian, Idaho, 83642, United States

  • Saint Luke's Cancer Institute - Nampa

    RECRUITING

    Nampa, Idaho, 83686, United States

  • Saint Luke's Cancer Institute - Twin Falls

    RECRUITING

    Twin Falls, Idaho, 83301, United States

  • Saint Mary Corwin Medical Center

    RECRUITING

    Pueblo, Colorado, 81004, United States

    Contact Email: •••••@•••••

  • Saint Patrick Hospital - Community Hospital

    RECRUITING

    Missoula, Montana, 59802, United States

  • Smilow Cancer Center/Yale-New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06510, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center - Guilford

    RECRUITING

    Guilford, Connecticut, 06437, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center - Waterford

    RECRUITING

    Waterford, Connecticut, 06385, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center - Westerly

    RECRUITING

    Westerly, Rhode Island, 02891, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center at Glastonbury

    RECRUITING

    Glastonbury, Connecticut, 06033, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center at Greenwich

    RECRUITING

    Greenwich, Connecticut, 06830, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center at Long Ridge

    RECRUITING

    Stamford, Connecticut, 06902, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center at Saint Francis

    RECRUITING

    Hartford, Connecticut, 06105, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center-Fairfield

    RECRUITING

    Fairfield, Connecticut, 06824, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital Care Center-Trumbull

    RECRUITING

    Trumbull, Connecticut, 06611, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital-Derby Care Center

    RECRUITING

    Derby, Connecticut, 06418, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital-Torrington Care Center

    RECRUITING

    Torrington, Connecticut, 06790, United States

    Contact Email: •••••@•••••

  • Smilow Cancer Hospital-Waterbury Care Center

    RECRUITING

    Waterbury, Connecticut, 06708, United States

    Contact Email: •••••@•••••

  • Southwest Oncology PC

    RECRUITING

    Durango, Colorado, 81301, United States

    Contact Email: •••••@•••••

  • Swedish Cancer Institute-Edmonds

    RECRUITING

    Edmonds, Washington, 98026, United States

  • Swedish Cancer Institute-Issaquah

    RECRUITING

    Issaquah, Washington, 98029, United States

  • Swedish Medical Center-Ballard Campus

    RECRUITING

    Seattle, Washington, 98107, United States

  • Swedish Medical Center-Cherry Hill

    RECRUITING

    Seattle, Washington, 98122-5711, United States

  • Swedish Medical Center-First Hill

    RECRUITING

    Seattle, Washington, 98122, United States

  • TriHealth Cancer Institute-Anderson

    RECRUITING

    Cincinnati, Ohio, 45255, United States

    Contact Email: •••••@•••••

  • TriHealth Cancer Institute-Westside

    RECRUITING

    Cincinnati, Ohio, 45247, United States

    Contact Email: •••••@•••••

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Washington Medical Center - Montlake

    RECRUITING

    Seattle, Washington, 98195, United States

  • Walter Knox Memorial Hospital

    RECRUITING

    Emmett, Idaho, 83617, United States

  • Welch Cancer Center

    RECRUITING

    Sheridan, Wyoming, 82801, United States

    Contact Email: •••••@•••••

  • Woodland Memorial Hospital

    RECRUITING

    Woodland, California, 95695, United States

    Contact Email: •••••@•••••

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

    Contact Email: •••••@•••••

  • Yale-New Haven Hospital North Haven Medical Center

    RECRUITING

    North Haven, Connecticut, 06473, United States

    Contact Email: •••••@•••••

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