Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response | NCT06592924 | Trialant

Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response | NCT06592924 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Histologically/cytologically confirmed adenocarcinoma of the prostate or participants with a PSA >100 ng/ml (100 ug/L) and radiographic evidence of metastatic disease at diagnosis.

Metastatic disease by conventional imaging (bone scan or CT and/or MRI or PSMA-PET scan at the time of ADT initiation.

PSA of ≥ 2.0 ng/ml (2.0 ug/L) prior to commencement of ADT (this refers to patients who have histologically/cytologically confirmed adenocarcinoma of the prostate)

Patients will have recovered from any treatment-related toxicities prior to enrollment (unless ≤ grade 1, irreversible, or considered by investigator as not clinically significant).

Patients may enroll with persistent toxicities attributable to ADT, including hot flushes and fatigue, of any grade, provided these toxicities are clinically stable, not rapidly worsening, and not considered by the Investigator to pose a safety risk or impair the patient's ability to comply with study procedures. Such toxicities do not need to resolve to Grade ≤1 prior to study entry.

Receipt of ADT for mCSPC for at least 6 months and no greater than 12 months (+/- 3 weeks) at time of enrollment.

Receipt of ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months (+/- 2 weeks) at time of enrollment

Patients may have had radiotherapy to prostatic bed and/or metastatic sites prior to enrollment. Potential trial participants should have recovered from radiotherapy-related toxicities prior to enrollment.

Serum testosterone <1.7 nmol/L or 50 ng/dL.

PSA ≥ 0.2 ng/ml (0.2 ug/L) within 28 days of enrollment.

Candidate for docetaxel chemotherapy

ECOG Performance Status (PS) 0 to 2.

Adequate organ and marrow function measured within 28 days prior to enrollment.

Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.

Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.

In accordance with CCTG policy, protocol treatment is to begin within 10 working days of participant enrollment.

If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception

HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

Participant access to all protocol therapies must be confirmed prior to enrollment

Exclusion Criteria:

Confirmed PSA progression, defined by an increase in PSA of 25% above the nadir since achieving castration on ADT, an absolute increase in PSA value of 2.0 ng/ml (ug/L) above nadir, and a subsequent increase in PSA of 25% further separated by 3 or more weeks.

Evidence of confirmed radiographic progression or clinical progression since start of ADT. Participants may be enrolled on the study if, in the opinion of the investigator, any new bone lesions on bone scan and CT represent flare or treatment effect.

Docetaxel criteria:

Prior treatment with taxane chemotherapy

Grade 2 or worse peripheral neuropathy

Severe hypersensitivity to drugs formulated with polysorbate 80

Clinically significant cardiac disease including:

History of unstable angina pectoris, symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry.

History of documented congestive heart failure (New York Heart Association functions classification III-IV).

Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous.

Patients with a prior or concurrent malignancy whose natural history of treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Concurrent treatment with other anti-cancer systemic therapy other than ADT and ARPI.

Live attenuated vaccination administered within 30 days prior to enrollment/randomization.

For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

Participants 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, they are eligible if they have an undetectable HCV viral load.

High-grade neuroendocrine prostate cancer or small cell features (except if a participant has no histological diagnosis but a PSA >100 ng/ml (>100 ug/L) at diagnosis and radiographic evidence of metastatic disease)

Anchorage Associates in Radiation MedicineRecruiting

Anchorage, Alaska 98508, United States

Site Public ContactContact

AKPAMC.OncologyResearchSupport@providence.org907-212-6871

Charles W. DrescherPrincipal Investigator

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Nampa, Idaho 83687, United States

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Chicago, Illinois 60612, United States

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Elmhurst, Illinois 60126, United States

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Carroll, Iowa 51401, United States

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Clive, Iowa 50325, United States

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Des Moines, Iowa 50314, United States

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Des Moines, Iowa 50314, United States

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Bardstown, Kentucky 40004, United States

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Corbin, Kentucky 40701, United States

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Lexington, Kentucky 40504, United States

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Lexington, Kentucky 40504, United States

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Lexington, Kentucky 40509, United States

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Lexington, Kentucky 40536, United States

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London, Kentucky 40741, United States

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Louisville, Kentucky 40202, United States

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Louisville, Kentucky 40207, United States

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Louisville, Kentucky 40245, United States

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Mount Sterling, Kentucky 40353, United States

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Baton Rouge, Louisiana 70809, United States

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Covington, Louisiana 70433, United States

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Metairie, Louisiana 70002, United States

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New Orleans, Louisiana 70112, United States

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New Orleans, Louisiana 70121, United States

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Baltimore, Maryland 21287, United States

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Elkton, Maryland 21921, United States

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Ann Arbor, Michigan 48105, United States

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Ann Arbor, Michigan 48109, United States

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Bay City, Michigan 48706, United States

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Brighton, Michigan 48116, United States

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Brownstown, Michigan 48183, United States

Site Public ContactContact

CTOResearch@hfhs.org313-916-3721

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Clinton Township, Michigan 48038, United States

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Dearborn, Michigan 48126, United States

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Detroit, Michigan 48201, United States

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Detroit, Michigan 48202, United States

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Farmington Hills, Michigan 48334, United States

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Lansing, Michigan 48910, United States

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Aitkin, Minnesota 56431, United States

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Brainerd, Minnesota 56401, United States

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Detroit Lakes, Minnesota 56501, United States

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Duluth, Minnesota 55805, United States

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Duluth, Minnesota 55805, United States

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Hibbing, Minnesota 55746, United States

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International Falls, Minnesota 56649, United States

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Moose Lake, Minnesota 55767, United States

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Park Rapids, Minnesota 56470, United States

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Pequot Lakes, Minnesota 56472, United States

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Pine River, Minnesota 56474, United States

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Saint Cloud, Minnesota 56303, United States

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Sandstone, Minnesota 55072, United States

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Staples, Minnesota 56479, United States

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Virginia, Minnesota 55792, United States

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Jackson, Mississippi 39216, United States

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City of Saint Peters, Missouri 63376, United States

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Creve Coeur, Missouri 63141, United States

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St Louis, Missouri 63110, United States

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St Louis, Missouri 63129, United States

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St Louis, Missouri 63136, United States

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Anaconda, Montana 59711, United States

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Billings, Montana 59101, United States

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Bozeman, Montana 59715, United States

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Great Falls, Montana 59405, United States

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Great Falls, Montana 59405, United States

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Havre, Montana 59501, United States

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Helena, Montana 59601, United States

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Kalispell, Montana 59901, United States

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Missoula, Montana 59802, United States

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Missoula, Montana 59804, United States

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Grand Island, Nebraska 68803, United States

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Kearney, Nebraska 68847, United States

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Omaha, Nebraska 68122, United States

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Omaha, Nebraska 68124, United States

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Omaha, Nebraska 68130, United States

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Lebanon, New Hampshire 03756, United States

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The Bronx, New York 10461, United States

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Charlotte, North Carolina 28203, United States

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Charlotte, North Carolina 28262, United States

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Charlotte, North Carolina 28277, United States

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Clemmons, North Carolina 27012, United States

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Concord, North Carolina 28025, United States

Levine Cancer Institute - RutherfordRecruiting

Forest City, North Carolina 28043, United States

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Gastonia, North Carolina 28054, United States

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Lincolnton, North Carolina 28092, United States

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Matthews, North Carolina 28104, United States

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Monroe, North Carolina 28112, United States

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Pinehurst, North Carolina 28374, United States

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Winston-Salem, North Carolina 27157, United States

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Fargo, North Dakota 58103, United States

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Jamestown, North Dakota 58401, United States

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Akron, Ohio 44307, United States

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Avon, Ohio 44011, United States

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Beachwood, Ohio 44122, United States

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Cincinnati, Ohio 45220, United States

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Cincinnati, Ohio 45242, United States

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Cincinnati, Ohio 45247, United States

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Cincinnati, Ohio 45255, United States

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Cleveland, Ohio 44106, United States

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Cleveland, Ohio 44109, United States

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Cleveland, Ohio 44111, United States

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Cleveland, Ohio 44195, United States

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Columbus, Ohio 43210, United States

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Mayfield Heights, Ohio 44124, United States

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Mentor, Ohio 44060, United States

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Sylvania, Ohio 43560, United States

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Toledo, Ohio 43606, United States

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Warrensville Heights, Ohio 44122, United States

Cleveland Clinic Wooster Family Health and Surgery CenterRecruiting

Wooster, Ohio 44691, United States

Cancer Centers of Southwest Oklahoma ResearchRecruiting

Lawton, Oklahoma 73505, United States

University of Oklahoma Health Sciences CenterRecruiting

Oklahoma City, Oklahoma 73104, United States

Saint Alphonsus Cancer Care Center-Baker CitySuspended

Baker City, Oregon 97814, United States

Saint Charles Health SystemRecruiting

Bend, Oregon 97701, United States

Clackamas Radiation Oncology CenterRecruiting

Clackamas, Oregon 97015, United States

Bay Area HospitalRecruiting

Coos Bay, Oregon 97420, United States

Providence Hood River Memorial HospitalRecruiting

Hood River, Oregon 97031, United States

Asante Rogue Regional Medical CenterRecruiting

Medford, Oregon 97504, United States

Providence Newberg Medical CenterRecruiting

Newberg, Oregon 97132, United States

Saint Alphonsus Cancer Care Center-OntarioSuspended

Ontario, Oregon 97914, United States

Providence Willamette Falls Medical CenterRecruiting

Oregon City, Oregon 97045, United States

Providence Portland Medical CenterRecruiting

Portland, Oregon 97213, United States

Providence Saint Vincent Medical CenterRecruiting

Portland, Oregon 97225, United States

Oregon Health and Science UniversityRecruiting

Portland, Oregon 97239, United States

Saint Charles Health System-RedmondRecruiting

Redmond, Oregon 97756, United States

Christiana Care Health System-Concord Health CenterRecruiting

Chadds Ford, Pennsylvania 19317, United States

Geisinger Medical CenterRecruiting

Danville, Pennsylvania 17822, United States

Geisinger Cancer Center Dickson CityRecruiting

Dickson City, Pennsylvania 18519, United States

Geisinger Medical Center-Cancer Center HazletonRecruiting

Hazleton, Pennsylvania 18201, United States

Geisinger Medical Oncology-LewisburgRecruiting

Lewisburg, Pennsylvania 17837, United States

Philadelphia Veterans Administration Medical CenterRecruiting

Philadelphia, Pennsylvania 19104, United States

Geisinger Cancer Services-PottsvilleRecruiting

Pottsville, Pennsylvania 17901, United States

Community Medical CenterRecruiting

Scranton, Pennsylvania 18510, United States

Geisinger Wyoming Valley/Henry Cancer CenterRecruiting

Wilkes-Barre, Pennsylvania 18711, United States

Rhode Island HospitalRecruiting

Providence, Rhode Island 02903, United States

Miriam HospitalSuspended

Providence, Rhode Island 02906, United States

Medical University of South CarolinaRecruiting

Charleston, South Carolina 29425, United States

Levine Cancer Institute-Rock HillRecruiting

Rock Hill, South Carolina 29732, United States

Vanderbilt University/Ingram Cancer CenterRecruiting

Nashville, Tennessee 37232, United States

Houston Methodist San Jacinto HospitalRecruiting

Baytown, Texas 77521, United States

Houston Methodist Cypress HospitalRecruiting

Cypress, Texas 77429, United States

Dallas VA Medical CenterRecruiting

Dallas, Texas 75216, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting

Houston, Texas 77030, United States

Ben Taub General HospitalRecruiting

Houston, Texas 77030, United States

Houston Methodist HospitalRecruiting

Houston, Texas 77030, United States

Michael E DeBakey VA Medical CenterRecruiting

Houston, Texas 77030, United States

UT MD Anderson Cancer CenterRecruiting

Houston, Texas 77030, United States

Methodist Willowbrook HospitalRecruiting

Houston, Texas 77070, United States

Houston Methodist West HospitalRecruiting

Houston, Texas 77094, United States

Houston Methodist Saint John HospitalRecruiting

Nassau Bay, Texas 77058, United States

Houston Methodist Sugar Land HospitalRecruiting

Sugar Land, Texas 77479, United States

Houston Methodist The Woodlands HospitalRecruiting

The Woodlands, Texas 77385, United States

Huntsman Cancer Institute/University of UtahRecruiting

Salt Lake City, Utah 84112, United States

Dartmouth Cancer Center - NorthRecruiting

Saint Johnsbury, Vermont 05819, United States

University of Virginia Cancer CenterRecruiting

Charlottesville, Virginia 22908, United States

Bon Secours Memorial Regional Medical CenterRecruiting

Mechanicsville, Virginia 23116, United States

Bon Secours Saint Francis Medical CenterRecruiting

Midlothian, Virginia 23114, United States

Bon Secours Richmond Community HospitalRecruiting

Richmond, Virginia 23223, United States

Bon Secours Saint Mary's HospitalRecruiting

Richmond, Virginia 23226, United States

Bon Secours Cancer Institute at Reynolds CrossingRecruiting

Richmond, Virginia 23230, United States

Providence Regional Cancer System-AberdeenRecruiting

Aberdeen, Washington 98520, United States

FHCC OverlakeRecruiting

Bellevue, Washington 98004, United States

PeaceHealth Saint Joseph Medical CenterRecruiting

Bellingham, Washington 98225, United States

Providence Regional Cancer System-CentraliaRecruiting

Centralia, Washington 98531, United States

Swedish Cancer Institute-EdmondsRecruiting

Edmonds, Washington 98026, United States

Providence Regional Cancer PartnershipRecruiting

Everett, Washington 98201, United States

Swedish Cancer Institute-IssaquahRecruiting

Issaquah, Washington 98029, United States

Kadlec Clinic Hematology and OncologyRecruiting

Kennewick, Washington 99336, United States

FHCC at EvergreenHealthRecruiting

Kirkland, Washington 98034, United States

Providence Regional Cancer System-LaceyRecruiting

Lacey, Washington 98503, United States

PeaceHealth Saint John Medical CenterRecruiting

Longview, Washington 98632, United States

Skagit Regional Health Cancer Care CenterRecruiting

Mount Vernon, Washington 98274, United States

Swedish Medical Center-Ballard CampusRecruiting

Seattle, Washington 98107, United States

Fred Hutchinson Cancer CenterRecruiting

Seattle, Washington 98109, United States

Swedish Medical Center-Cherry HillRecruiting

Seattle, Washington 98122-5711, United States

Swedish Medical Center-First HillRecruiting

Seattle, Washington 98122, United States

FHCC at Northwest HospitalRecruiting

Seattle, Washington 98133, United States

University of Washington Medical Center - MontlakeRecruiting

Seattle, Washington 98195, United States

PeaceHealth United General Medical CenterRecruiting

Sedro-Woolley, Washington 98284, United States

Saint Joseph Medical Center Hematology and Oncology - SilverdaleRecruiting

Silverdale, Washington 98383, United States

Cancer Care Northwest - Spokane SouthRecruiting

Spokane, Washington 99202, United States

Cancer Care Northwest-ValleyRecruiting

Spokane, Washington 99216, United States

Cancer Care Northwest-North SpokaneRecruiting

Spokane, Washington 99218, United States

PeaceHealth Southwest Medical CenterRecruiting

Vancouver, Washington 98664, United States

Providence Saint Mary Regional Cancer CenterRecruiting

Walla Walla, Washington 99362, United States

Duluth Clinic AshlandRecruiting

Ashland, Wisconsin 54806, United States

Northwest Wisconsin Cancer CenterRecruiting

Ashland, Wisconsin 54806, United States

Marshfield Medical Center-EC Cancer CenterRecruiting

Eau Claire, Wisconsin 54701, United States

Essentia Health-Hayward ClinicRecruiting

Hayward, Wisconsin 54843, United States

Tamarack Health Hayward Medical CenterRecruiting

Hayward, Wisconsin 54843, United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterRecruiting

Madison, Wisconsin 53718, United States

University of Wisconsin Carbone Cancer Center - University HospitalRecruiting

Madison, Wisconsin 53792, United States

Marshfield Medical Center-MarshfieldRecruiting

Marshfield, Wisconsin 54449, United States

ProHealth D N Greenwald CenterActive, not recruiting

Mukwonago, Wisconsin 53149, United States

ProHealth Oconomowoc Memorial HospitalActive, not recruiting

Oconomowoc, Wisconsin 53066, United States

Marshfield Medical Center-Rice LakeRecruiting

Rice Lake, Wisconsin 54868, United States

Essentia Health-Spooner ClinicRecruiting

Spooner, Wisconsin 54801, United States

Marshfield Medical Center-River Region at Stevens PointRecruiting

Stevens Point, Wisconsin 54482, United States

Essentia Health Saint Mary's Hospital - SuperiorRecruiting

Superior, Wisconsin 54880, United States

ProHealth Waukesha Memorial HospitalActive, not recruiting

Waukesha, Wisconsin 53188, United States

UW Cancer Center at ProHealth CareActive, not recruiting

Waukesha, Wisconsin 53188, United States

Marshfield Medical Center - WestonRecruiting

Weston, Wisconsin 54476, United States

Memorial Hospital of Laramie CountyRecruiting

Cheyenne, Wyoming 82001, United States

Billings Clinic-CodyRecruiting

Cody, Wyoming 82414, United States

Cross Cancer InstituteRecruiting

Edmonton, Alberta T6G 1Z2, Canada

BCCA-Vancouver Cancer CentreRecruiting

Vancouver, British Columbia V5Z 4E6, Canada

CancerCare ManitobaRecruiting

Winnipeg, Manitoba R3E 0V9, Canada

Atlantic Health Sciences Corporation-Saint John Regional HospitalRecruiting

Saint John, New Brunswick E2L 4L2, Canada

Health Sciences NorthRecruiting

Greater Sudbury, Ontario P3E 5J1, Canada

Juravinski Cancer Centre at Hamilton Health SciencesRecruiting

Hamilton, Ontario L8V 5C2, Canada

Kingston Health Sciences CentreRecruiting

Kingston, Ontario K7L 2V7, Canada

Waterloo Regional Health NetworkRecruiting

Kitchener, Ontario N2G 1G3, Canada

London Regional Cancer ProgramRecruiting

London, Ontario N6A 4L6, Canada

Trillium Health Partners - Credit Valley HospitalRecruiting

Mississauga, Ontario L5M 2N1, Canada

Ottawa Hospital and Cancer Center-General CampusRecruiting

Ottawa, Ontario K1H 8L6, Canada

Niagara Health System-Saint Catharines GeneralRecruiting

Saint Catharines, Ontario L2S 0A9, Canada

Site Public ContactContact

905-682-6451

Odette Cancer Centre- Sunnybrook Health Sciences CentreRecruiting

Toronto, Ontario M4N 3M5, Canada

University Health Network-Princess Margaret HospitalRecruiting

Toronto, Ontario M5G 2M9, Canada

CSSS Champlain-Charles Le MoyneRecruiting

Greenfield Park, Quebec J4V 2H1, Canada

CIUSSSEMTL-Hopital Maisonneuve-RosemontRecruiting

Montreal, Quebec H1T 2M4, Canada

Jewish General HospitalRecruiting

Montreal, Quebec H3T 1E2, Canada

CHA Hopital L'Enfant-JesusRecruiting

Québec, Quebec G1J 1Z4, Canada

Saskatoon Cancer CentreRecruiting

Saskatoon, Saskatchewan S7N 4H4, Canada

Instituto Nacional De Cancerologia de MexicoRecruiting

Mexico City, Tlalpan 14080, Mexico

Hospital de Clinicas Dr Manuel QuintelaRecruiting

Montevideo, 11600, Uruguay