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NCT07200830RecruitingPhase 3

Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial

Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

This randomized phase III trial examines whether lengthening the dosage interval in an adaptive manner for the prostate cancer drug lutetium 177 Lu PSMA RLT improves quality of life without decreasing lifespan when compared to the standard way this medication is given. This study is for patients with hormone resistant prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Hormone resistant prostate cancer often has many cells containing a protein called prostate-specific membrane antigen (PSMA) on their surface. The normal cells in the prostate do not normally express as much PSMA protein on their surface as cancer cells. Lutetium 177 Lu PSMA RLT binds to the PSMA protein on the tumor cells. It builds up in these cells and gives off radiation that may kill them. Typically, this medication is given at the same dose every 6 weeks for up to 6 doses. In this trial, researchers want to see if treatment following the first two doses of lutetium 177 Lu PSMA RLT can be delayed until there is evidence of disease activity. This may be an effective way to improve quality of life without decreasing lifespan in patients with advanced prostate cancer.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1524 (estimated)
First submitted
23 Sept 2025
Start date
31 Mar 2026
Primary completion date
9 Sept 2034
Lead sponsor
Alliance for Clinical Trials in Oncology
NCT number
NCT07200830

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1524
  • From 31 Mar 2026 to the primary completion date, 9 Sept 2034
  • 142 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 (STEP 0): Patients must have histological, pathological, and/or cytological confirmation of prostate adenocarcinoma
  • PRE-REGISTRATION (STEP 0): Patients must have a positive PSMA PET/CT scan (either gallium Ga 68 gozetotide \[68Ga-PSMA-11\], fluorine F 18 piflufolastat \[18F- DCFPyl\], or fluorine F 18 flotufolastat gallium \[18F-rhPSMA-7.3\]), as defined as uptake greater than liver with no PSMA negative measurable soft tissue disease
  • PRE-REGISTRATION (STEP 0): PSA greater than 2.0 ng/mL
  • PRE-REGISTRATION (STEP 0): Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
    • Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL
    • Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions
    • Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Clinical Trials Working Group 3 \[PCWG3\] criteria, Scher et al 2016)
  • PRE-REGISTRATION (STEP 0): Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L)
  • PRE-REGISTRATION (STEP 0): Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (to include either apalutamide, darolutamide, enzalutamide, or abiraterone)
    • \* ARPI must be stopped at least 4 weeks prior to pre-registration
  • PRE-REGISTRATION (STEP 0): Patients must not have previously received a taxane based chemotherapy regimen for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate carcinoma (mHSPC) or in the neoadjuvant or adjuvant setting is permitted if completed at least 12 months prior to pre-registration
  • PRE-REGISTRATION (STEP 0): Patients must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.)
  • PRE-REGISTRATION (STEP 0): Patients on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to pre-registration are eligible
  • PRE-REGISTRATION (STEP 0): Previous treatment with strontium Sr-89 (strontium-89), samarium Sm-153 (samarium-153), rhenium Re 186 (rhenium-186), rhenium Re 188 (rhenium-188), radium Ra 223 (radium-223) or hemi-body irradiation within 6 months prior to pre-registration is not allowed. Previous PSMA-targeted radioligand therapy is not allowed
  • PRE-REGISTRATION (STEP 0): Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\]) within 28 days prior to pre-registration is not allowed
  • PRE-REGISTRATION (STEP 0): Age ≥ 18 years
  • PRE-REGISTRATION (STEP 0): Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  • PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
  • PRE-REGISTRATION (STEP 0): Platelet count ≥ 100,000/mm\^3
  • PRE-REGISTRATION (STEP 0): Total bilirubin \< 1.5 x upper limit of normal (ULN) or \< 3 x ULN in patients with Gilbert's syndrome
  • PRE-REGISTRATION (STEP 0): Creatinine clearance estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73m\^2 using the Modification of Diet in Renal Disease (MDRD) equation
  • PRE-REGISTRATION (STEP 0): No acute biliary or urinary obstruction
  • PRE-REGISTRATION (STEP 0): Patients with treated/stable brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
    • \* Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast)
  • PRE-REGISTRATION (STEP 0): Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
  • PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • PRE-REGISTRATION (STEP 0): 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
  • PRE-REGISTRATION (STEP 0): Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
  • PRE-REGISTRATION (STEP 0): No investigational agents within 28 days prior to pre-registration
  • PRE-REGISTRATION (STEP 0): No other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
  • PRE-REGISTRATION (STEP 0): No known hypersensitivity to the components of the study therapy or its analogs
  • PRE-REGISTRATION (STEP 0): No transfusion within 30 days of pre-registration
  • PRE-REGISTRATION (STEP 0): No symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
  • PRE-REGISTRATION (STEP 0): Ability to read and comprehend English or Spanish
  • REGISTRATION (STEP 1): Completion of 2 doses of 177Lu PSMA RLT
  • REGISTRATION (STEP 1): PSA decline ≥ 50% between C1 D1 (screening) and C2 D22 +/-3 days
  • REGISTRATION (STEP 1): ECOG Performance Status ≤ 2
  • REGISTRATION (STEP 1): Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
  • REGISTRATION (STEP 1): Platelet count ≥ 100,000/mm\^3
  • REGISTRATION (STEP 1): Creatinine clearance eGFR ≥ 40 mL/min/1.73m\^2 using the Modification of Diet in Renal Disease (MDRD) equation

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

Full criteria on ClinicalTrials.gov

Sites (142)

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

SiteCityCountrySite status
Mary Greeley Medical Center
Coordinator of this site? Confirm its status
AmesUnited StatesRecruiting
McFarland Clinic - Ames
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AmesUnited StatesRecruiting
Community Hospital of Anaconda
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AnacondaUnited StatesRecruiting
Providence Alaska Medical Center
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AnchorageUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Coordinator of this site? Confirm its status
AnkenyUnited StatesSuspended
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting
UCHealth University of Colorado Hospital
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
AIS Cancer Center at San Joaquin Community Hospital
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BakersfieldUnited StatesRecruiting
Maryland Proton Treatment Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
University of Maryland/Greenebaum Cancer Center
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BaltimoreUnited StatesRecruiting
Memorial Sloan Kettering Basking Ridge
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Basking RidgeUnited StatesRecruiting
Bronson Battle Creek
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Battle CreekUnited StatesRecruiting
UM Upper Chesapeake Medical Center
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Bel AirUnited StatesRecruiting
Billings Clinic Cancer Center
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BillingsUnited StatesRecruiting
Sanford Bismarck Medical Center
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BismarckUnited StatesRecruiting
McFarland Clinic - Boone
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BooneUnited StatesSuspended
Bozeman Health Deaconess Hospital
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BozemanUnited StatesRecruiting
Henry Ford Cancer Institute-Downriver
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BrownstownUnited StatesRecruiting
Roswell Park Cancer Institute
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BuffaloUnited StatesRecruiting
Minnesota Oncology - Burnsville
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BurnsvilleUnited StatesSuspended
Cambridge Medical Center
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CambridgeUnited StatesSuspended
AtlantiCare Health Park-Cape May Court House
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Cape May Court HouseUnited StatesRecruiting
Saint Anthony Regional Hospital
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CarrollUnited StatesSuspended
Memorial Hospital of Laramie County
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CheyenneUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
MetroHealth Medical Center
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ClevelandUnited StatesRecruiting
Henry Ford Macomb Hospital-Clinton Township
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Clinton TownshipUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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CliveUnited StatesSuspended
Billings Clinic-Cody
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CodyUnited StatesSuspended
Kootenai Health - Coeur d'Alene
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Coeur d'AleneUnited StatesRecruiting
Memorial Hospital North
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Colorado SpringsUnited StatesRecruiting
UCHealth Memorial Hospital Central
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Colorado SpringsUnited StatesRecruiting
Central Maryland Radiation Oncology in Howard County
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ColumbiaUnited StatesRecruiting
Memorial Sloan Kettering Commack
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CommackUnited StatesRecruiting
Mercy Hospital
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Coon RapidsUnited StatesSuspended
Henry Ford Medical Center-Fairlane
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DearbornUnited StatesRecruiting
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesRecruiting
Decatur Memorial Hospital
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DecaturUnited StatesRecruiting
Northwestern Medicine Cancer Center Kishwaukee
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DeKalbUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des MoinesUnited StatesSuspended
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des MoinesUnited StatesSuspended
Iowa Methodist Medical Center
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Des MoinesUnited StatesRecruiting
Broadlawns Medical Center
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Des MoinesUnited StatesSuspended
Henry Ford Hospital
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DetroitUnited StatesRecruiting
University of Maryland Shore Medical Center at Easton
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EastonUnited StatesRecruiting
Fairview Southdale Hospital
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EdinaUnited StatesSuspended
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesRecruiting
AtlantiCare Surgery Center
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Egg HarborUnited StatesRecruiting
Sanford Broadway Medical Center
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FargoUnited StatesRecruiting
Sanford Roger Maris Cancer Center
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FargoUnited StatesRecruiting
UI Healthcare Mission Cancer and Blood - Fort Dodge
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Fort DodgeUnited StatesSuspended
McFarland Clinic - Trinity Cancer Center
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Fort DodgeUnited StatesRecruiting
Northwestern Medicine Cancer Center Delnor
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GenevaUnited StatesRecruiting
UM Baltimore Washington Medical Center/Tate Cancer Center
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Glen BurnieUnited StatesRecruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand RapidsUnited StatesRecruiting
Benefis Sletten Cancer Institute
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Great FallsUnited StatesRecruiting
Great Falls Clinic
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Great FallsUnited StatesSuspended
Memorial Sloan Kettering Westchester
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HarrisonUnited StatesRecruiting
Hi-Line Sletten Cancer Center
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HavreUnited StatesSuspended
Benefis Helena Specialty Center
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HelenaUnited StatesSuspended
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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IrvineUnited StatesRecruiting
City of Hope at Irvine Lennar
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IrvineUnited StatesRecruiting
Allegiance Health
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JacksonUnited StatesRecruiting
McFarland Clinic - Jefferson
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JeffersonUnited StatesSuspended
West Michigan Cancer Center
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KalamazooUnited StatesRecruiting
Bronson Methodist Hospital
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KalamazooUnited StatesRecruiting
Logan Health Medical Center
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KalispellUnited StatesRecruiting
UC San Diego Moores Cancer Center
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La JollaUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Covenant Medical Center-Lakeside
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LubbockUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
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MadisonUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesRecruiting
Fairview Clinics and Surgery Center Maple Grove
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Maple GroveUnited StatesSuspended
Minnesota Oncology Hematology PA-Maplewood
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MaplewoodUnited StatesSuspended
Saint John's Hospital - Healtheast
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MaplewoodUnited StatesSuspended
McFarland Clinic - Marshalltown
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MarshalltownUnited StatesRecruiting
Froedtert Menomonee Falls Hospital
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Menomonee FallsUnited StatesRecruiting
Memorial Sloan Kettering Monmouth
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MiddletownUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Abbott-Northwestern Hospital
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MinneapolisUnited StatesSuspended
Hennepin County Medical Center
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MinneapolisUnited StatesSuspended
Community Medical Center
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MissoulaUnited StatesRecruiting
Memorial Sloan Kettering Bergen
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MontvaleUnited StatesRecruiting
SSM Health Good Samaritan
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Mount VernonUnited StatesRecruiting
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesRecruiting
Helen F Graham Cancer Center
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NewarkUnited StatesRecruiting
Froedtert and MCW Moorland Reserve Health Center
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New BerlinUnited StatesRecruiting
CTCA at Southeastern Regional Medical Center
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NewnanUnited StatesRecruiting
Cancer Center of Western Wisconsin
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New RichmondUnited StatesSuspended
New Ulm Medical Center
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New UlmUnited StatesSuspended
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Niles Hospital
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NilesUnited StatesRecruiting
Henry Ford Medical Center-Columbus
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NoviUnited StatesRecruiting
Northwestern Medicine Oak Brook
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Oak BrookUnited StatesRecruiting
Drexel Town Square Health Center
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Oak CreekUnited StatesRecruiting
HSHS Saint Elizabeth's Hospital
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O'FallonUnited 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
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesRecruiting
Northwestern Medicine Orland Park
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Orland ParkUnited StatesRecruiting
UI Healthcare Mission Cancer and Blood - Pella
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PellaUnited StatesSuspended
Capital Health Medical Center-Hopewell
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PenningtonUnited StatesRecruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
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PontiacUnited StatesRecruiting
Providence Portland Medical Center
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PortlandUnited StatesRecruiting
Providence Saint Vincent Medical Center
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PortlandUnited StatesRecruiting
Kootenai Clinic Cancer Services - Post Falls
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Post FallsUnited StatesRecruiting
Fairview Northland Medical Center
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PrincetonUnited StatesSuspended
Corewell Health Reed City Hospital
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Reed CityUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
North Memorial Medical Health Center
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RobbinsdaleUnited StatesSuspended
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
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Saint JosephUnited StatesRecruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint JosephUnited StatesRecruiting
Heartland Regional Medical Center
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Saint JosephUnited StatesRecruiting
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesSuspended
United Hospital
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Saint PaulUnited StatesRecruiting
Regions Hospital
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Saint PaulUnited StatesSuspended
UC San Diego Medical Center - Hillcrest
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San DiegoUnited StatesRecruiting
Kootenai Clinic Cancer Services - Sandpoint
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SandpointUnited StatesRecruiting
Swedish Medical Center-First Hill
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SeattleUnited StatesRecruiting
Saint Francis Regional Medical Center
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ShakopeeUnited StatesSuspended
Sanford USD Medical Center - Sioux Falls
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Sioux FallsUnited StatesRecruiting
Sanford Cancer Center Oncology Clinic
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Sioux FallsUnited StatesRecruiting
Lakeview Hospital
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StillwaterUnited StatesSuspended
Missouri Baptist Medical Center
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St LouisUnited StatesRecruiting
Montefiore Medical Center-Einstein Campus
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The BronxUnited StatesRecruiting
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesRecruiting
Munson Medical Center
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Traverse CityUnited StatesRecruiting
Memorial Sloan Kettering Nassau
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UniondaleUnited StatesRecruiting
Ridgeview Medical Center
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WaconiaUnited StatesSuspended
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
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WaukeeUnited StatesSuspended
Froedtert West Bend Hospital/Kraemer Cancer Center
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West BendUnited StatesRecruiting
Henry Ford West Bloomfield Hospital
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West BloomfieldUnited StatesRecruiting
The Iowa Clinic PC
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West Des MoinesUnited StatesSuspended
Rice Memorial Hospital
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WillmarUnited StatesSuspended
Minnesota Oncology Hematology PA-Woodbury
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WoodburyUnited StatesSuspended
Henry Ford Wyandotte Hospital
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WyandotteUnited StatesRecruiting
University of Michigan Health - West
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WyomingUnited StatesRecruiting
Fairview Lakes Medical Center
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WyomingUnited StatesSuspended
Midwestern Regional Medical Center
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ZionUnited StatesRecruiting

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