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NCT06632977RecruitingPhase 2

Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. 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. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
474 (estimated)
First submitted
1 Oct 2024
Start date
6 Feb 2025
Primary completion date
11 Apr 2030
Lead sponsor
Alliance for Clinical Trials in Oncology
NCT number
NCT06632977

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 474
  • From 6 Feb 2025 to the primary completion date, 11 Apr 2030
  • 108 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1.
  • PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available for submission per Section 6.2. For patients who have progressed on A032102 and are pre-registering again, repeat tissue procurement will not be mandated.
  • PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned based on pre-determined qualifying molecular/DNA alterations as stated in Section 4.8 after receipt of local molecular testing by the A032102 molecular tumor board (MTB). Final determination of arm assignment will be determined by the MTB. For qualifying DNA alteration determined by the MTB, testing may be from tumor tissue collected at any time or circulating tumor DNA (ctDNA) within 12 months of pre-registration. If no qualifying DNA alteration is identified based on the CLIA-certified next generation sequencing assay and MTB review, Caris testing, should be performed for both DNA/RNA profiling. Arm assignment based RNA requires testing of tumor tissue collected within 12 months of pre-registration and MTB review.
  • PRE-REGISTRATION: Age ≥ 18 years.
  • REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND one or more of the following criteria (choose all the apply): * PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng/mL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy. * Radiographic progression per RECIST 1.1 criteria for soft tissue lesions * Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
  • REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For reference, in the VISION trial this was defined as at least 1 PSMA+ metastatic lesion (defined as uptake greater than that of liver parenchyma in lesions of any size in any organ system) and no PSMA- lesions (defined as uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any solid organ lesion with a short axis of at least 1.0 cm, or in any bone lesion with a soft-tissue component of at least 1.0 cm in the short axis).
  • REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy. Prior lutetium LU177 vipivotide tetraxetan treatment is permitted but not mandated. Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.
  • REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of: * Chemotherapy-induced neuropathy * Fatigue * Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)
  • REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitor) within 2 weeks of registration. Treatment with abiraterone acetate, apalutamide, or darolutamide within 2 weeks of registration. Treatment with enzalutamide within 4 weeks of registration. No treatment with radiation therapy within 2 weeks of registration.
  • REGISTRATION: No major surgery within 4 weeks of registration.
  • REGISTRATION: No prior treatment with EZH inhibitors.
  • REGISTRATION: Prior treatment with cabazitaxel + carboplatin.
  • REGISTRATION: None of the following conditions: * Current use of moderate or strong cytochrome P450 (CYP)3A inducers. * Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. \* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Imminent or established spinal cord compression based on clinical and/or imaging findings. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before registration. * Significant cardiovascular defined as: * Myocardial infarction within 6 months prior to enrollment. * Uncontrolled angina pectoris within 6 months prior to enrollment. * New York Heart Association Class 3 or 4 congestive heart failure. * Corrected QT interval calculated by the Fridericia\'s formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. Patients with known history or current symptoms of cardiac disease, history of treatment with cardiotoxic agents, or agents/conditions known to impact QTcF should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and ECG. * Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \> 100 mmHg). * Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy. * Moderate to severe hepatic impairment (Child-Pugh Class C)
  • REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration.
  • REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration.
  • REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration.
  • REGISTRATION: No platelet transfusions within 2 weeks of registration.
  • REGISTRATION: No bleeding diathesis.
  • REGISTRATION: White blood cell count (WBC) ≥ 2,500/mcL.
  • REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500/mcL.
  • REGISTRATION: Hemoglobin ≥ 9 g/dL.
  • REGISTRATION: Platelet count ≥ 100,000/mcL.
  • REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
  • REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal \[ULN\] for subjects with documented Gilbert\'s disease).
  • REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.
  • REGISTRATION: Albumin ≥ 2.8 g/dL.
  • REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration/randomization office will relay the assignment to the submitting site. Once the site receives this assignment, they can register the patient to A032102. Any questions about the molecular board treatment assignments can be directed to.
  • RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease defined by radiographic progression on conventional imaging (CT/MRI chest, abdomen and pelvis and bone scan within 42 days of re-registration).
  • RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of: * Chemotherapy-induced neuropathy * Fatigue * Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo).
  • RE-REGISTRATION: None of the following conditions: * Imminent or established spinal cord compression based on clinical and/or imaging findings. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to re-registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before re-registration. * Corrected QT interval calculated by the Fridericia\'s formula (QTcF) \< 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. * Significant cardiovascular defined as: * Myocardial infarction within 6 months prior to enrollment. * Uncontrolled angina pectoris within 6 months prior to enrollment. * New York Heart Association Class 3 or 4 congestive heart failure. * Uncontrolled hypertension (resting systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
  • RE-REGISTRATION: ECOG Performance Status 0-2.
  • RE-REGISTRATION: No GCSF within 2 weeks of registration.
  • RE-REGISTRATION: No RBC transfusions within 2 weeks of registration.
  • RE-REGISTRATION: No platelet transfusions within 2 weeks of registration.
  • RE-REGISTRATION: WBC ≥ 2,500/mcL.
  • RE-REGISTRATION: ANC ≥ 1,500/mcL.
  • RE-REGISTRATION: Hemoglobin ≥ 9 g/dL (transfusions permitted).
  • RE-REGISTRATION: Platelet count ≥ 100,000/mcL.
  • RE-REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
  • RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert\'s disease).
  • RE-REGISTRATION: AST and ALT ≤ 3 x ULN.
  • RE-REGISTRATION: Albumin ≥ 2.8 g/dL.
  • RE-REGISTRATION: QT Interval (QTcF) \< 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF).
  • RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration/randomization office will relay the assignment to the site. Any questions about the molecular board treatment assignments can be directed to. Exclusion Criteria: \-

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (108)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McFarland Clinic - Ames
Coordinator of this site? Confirm its status
AmesUnited StatesRecruiting
University of Iowa Healthcare Cancer Services Quad Cities
Coordinator of this site? Confirm its status
BettendorfUnited StatesRecruiting
Billings Clinic Cancer Center
Coordinator of this site? Confirm its status
BillingsUnited StatesRecruiting
University of Alabama at Birmingham Cancer Center
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting
Illinois CancerCare-Bloomington
Coordinator of this site? Confirm its status
BloomingtonUnited StatesRecruiting
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesSuspended
Essentia Health Saint Joseph's Medical Center
Coordinator of this site? Confirm its status
BrainerdUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Coordinator of this site? Confirm its status
BrightonUnited StatesRecruiting
Roswell Park Cancer Institute
Coordinator of this site? Confirm its status
BuffaloUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Coordinator of this site? Confirm its status
CantonUnited StatesRecruiting
Illinois CancerCare-Canton
Coordinator of this site? Confirm its status
CantonUnited StatesRecruiting
UNC Lineberger Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
Vandalia Health/CAMC Institute for Academic Medicine
Coordinator of this site? Confirm its status
CharlestonUnited StatesActive, not recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Coordinator of this site? Confirm its status
ChelseaUnited StatesRecruiting
Enloe Medical Center
Coordinator of this site? Confirm its status
ChicoUnited StatesRecruiting
Siteman Cancer Center at Saint Peters Hospital
Coordinator of this site? Confirm its status
City of Saint PetersUnited StatesRecruiting
MetroHealth Medical Center
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Kootenai Health - Coeur d'Alene
Coordinator of this site? Confirm its status
Coeur d'AleneUnited StatesSuspended
Memorial Hospital North
Coordinator of this site? Confirm its status
Colorado SpringsUnited StatesRecruiting
UCHealth Memorial Hospital Central
Coordinator of this site? Confirm its status
Colorado SpringsUnited StatesRecruiting
MU Health - University Hospital/Ellis Fischel Cancer Center
Coordinator of this site? Confirm its status
ColumbiaUnited StatesActive, not recruiting
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesRecruiting
Siteman Cancer Center at West County Hospital
Coordinator of this site? Confirm its status
Creve CoeurUnited StatesRecruiting
UT Southwestern Simmons Cancer Center - RedBird
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Parkland Memorial Hospital
Coordinator of this site? Confirm its status
DallasUnited StatesSuspended
UT Southwestern/Simmons Cancer Center-Dallas
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DallasUnited StatesRecruiting
Carle at The Riverfront
Coordinator of this site? Confirm its status
DanvilleUnited StatesRecruiting
Essentia Health Cancer Center
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DuluthUnited StatesRecruiting
Saint Elizabeth Healthcare Edgewood
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EdgewoodUnited StatesRecruiting
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesRecruiting
Carle Physician Group-Effingham
Coordinator of this site? Confirm its status
EffinghamUnited StatesRecruiting
UC San Diego Health System - Encinitas
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EncinitasUnited StatesRecruiting
Illinois CancerCare-Eureka
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EurekaUnited StatesRecruiting
Essentia Health Cancer Center-South University Clinic
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FargoUnited StatesRecruiting
Poudre Valley Hospital
Coordinator of this site? Confirm its status
Fort CollinsUnited StatesRecruiting
Cancer Care and Hematology-Fort Collins
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Fort CollinsUnited StatesRecruiting
Saint Elizabeth Healthcare Fort Thomas
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Fort ThomasUnited StatesSuspended
UT Southwestern/Simmons Cancer Center-Fort Worth
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Fort WorthUnited StatesRecruiting
Dana-Farber Cancer Institute at Foxborough
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FoxboroughUnited StatesRecruiting
Gibbs Cancer Center-Gaffney
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GaffneyUnited StatesRecruiting
UCHealth Greeley Hospital
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GreeleyUnited StatesRecruiting
Gibbs Cancer Center-Pelham
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GreerUnited StatesRecruiting
Hackensack University Medical Center
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HackensackUnited StatesRecruiting
Tripler Army Medical Center
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HonoluluUnited StatesRecruiting
Edwards Comprehensive Cancer Center
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HuntingtonUnited StatesRecruiting
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited StatesRecruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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IrvineUnited StatesActive, not recruiting
Jupiter Medical Center
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JupiterUnited StatesRecruiting
University of Kansas Cancer Center
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Kansas CityUnited StatesRecruiting
UC San Diego Moores Cancer Center
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La JollaUnited StatesRecruiting
University of Michigan Health - Sparrow Lansing
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LansingUnited StatesRecruiting
Trinity Health Saint Mary Mercy Livonia Hospital
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LivoniaUnited StatesRecruiting
Medical Center of the Rockies
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LovelandUnited StatesRecruiting
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesRecruiting
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesRecruiting
Bon Secours Memorial Regional Medical Center
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MechanicsvilleUnited StatesRecruiting
Froedtert Menomonee Falls Hospital
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Menomonee FallsUnited StatesRecruiting
Dana Farber-Merrimack Valley
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MethuenUnited StatesRecruiting
Bon Secours Saint Francis Medical Center
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MidlothianUnited StatesRecruiting
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
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MilfordUnited StatesRecruiting
Beebe South Coastal Health Campus
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MillvilleUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesSuspended
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesRecruiting
Helen F Graham Cancer Center
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NewarkUnited StatesRecruiting
Mount Sinai Hospital
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New YorkUnited StatesRecruiting
Drexel Town Square Health Center
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Oak CreekUnited StatesRecruiting
Cancer Care Center of O'Fallon
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O'FallonUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
The University of Kansas Cancer Center - Olathe
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OlatheUnited StatesRecruiting
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesActive, not recruiting
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesRecruiting
University of Kansas Hospital-Indian Creek Campus
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Overland ParkUnited StatesRecruiting
Illinois CancerCare-Pekin
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PekinUnited StatesRecruiting
Illinois CancerCare-Peoria
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PeoriaUnited StatesRecruiting
Illinois CancerCare-Peru
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PeruUnited StatesRecruiting
Providence Saint Vincent Medical Center
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PortlandUnited StatesRecruiting
Providence Portland Medical Center
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PortlandUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesRecruiting
Beebe Health Campus
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Rehoboth BeachUnited StatesRecruiting
UT Southwestern Clinical Center at Richardson/Plano
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RichardsonUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
Bon Secours Richmond Community Hospital
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RichmondUnited StatesRecruiting
Bon Secours Cancer Institute at Reynolds Crossing
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RichmondUnited StatesRecruiting
VCU Massey Cancer Center at Stony Point
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RichmondUnited StatesRecruiting
Bon Secours Saint Mary's Hospital
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RichmondUnited StatesRecruiting
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesRecruiting
Coborn Cancer Center at Saint Cloud Hospital
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Saint CloudUnited StatesRecruiting
UC San Diego Medical Center - Hillcrest
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San DiegoUnited StatesRecruiting
Guthrie Medical Group PC-Robert Packer Hospital
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SayreUnited StatesActive, not recruiting
Swedish Medical Center-First Hill
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SeattleUnited StatesRecruiting
Memorial Hospital East
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ShilohUnited StatesRecruiting
Dana-Farber/Brigham and Women's Cancer Center at South Shore
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South WeymouthUnited StatesRecruiting
Spartanburg Medical Center
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SpartanburgUnited StatesRecruiting
Baystate Medical Center
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SpringfieldUnited StatesRecruiting
Stamford Hospital/Bennett Cancer Center
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StamfordUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Siteman Cancer Center at Christian Hospital
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St LouisUnited StatesRecruiting
Siteman Cancer Center-South County
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St LouisUnited StatesRecruiting
University of Kansas Health System Saint Francis Campus
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TopekaUnited StatesRecruiting
Banner University Medical Center - Tucson
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TucsonUnited StatesRecruiting
University of Arizona Cancer Center-North Campus
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TucsonUnited StatesRecruiting
SMC Center for Hematology Oncology Union
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UnionUnited StatesRecruiting
Carle Cancer Center
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UrbanaUnited StatesRecruiting
Illinois CancerCare - Washington
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WashingtonUnited StatesRecruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
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West BendUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesRecruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Coordinator of this site? Confirm its status
YpsilantiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.