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Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03511664
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Endocyte

Brief Summary:

The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.

Key secondary objectives are an arm-to-arm comparison of the following:

  • Radiographic progression-free survival (rPFS)
  • Response Evaluation Criteria in Solid Tumors (RECIST) response
  • Time to a first symptomatic skeletal event (SSE)

Additional Secondary Objectives:

  • Safety and tolerability of 177Lu-PSMA-617
  • Health-related quality of life (HRQoL; EQ-5D-5L, FACT-P and Brief Pain Inventory - Short Form (BPI-SF))
  • Health economics
  • Progression-free survival (PFS) (radiographic, clinical, or prostate-specific antigen [PSA] progression-free survival)
  • Biochemical response as measured by PSA. Alkaline phosphatase [ALP] levels and lactate dehydrogenase [LDH] levels will also be measured.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 177Lu-PSMA-617 Other: Best supportive/best standard of care Phase 3

Detailed Description:

Patients with PSMA positive scans will be randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus best supportive/best standard of care or to receive best supportive/best standard of care only. Best supportive/best standard of care will be determined by the treating physician/investigator but will exclude investigational agents, cytotoxic chemotherapy, other systemic radioisotopes, and hemi-body radiotherapy. Novel androgen axis drugs [NAADs] (such as abiraterone or enzalutamide) are allowed.

The study is open-label and patients will be monitored throughout the 6 to 10-month treatment period for survival, disease progression, and adverse events.

A long-term follow-up period will include the collection of survival and treatment updates, adverse events assessment, as well as blood for hematology and chemistry testing. During follow-up, patients will be contacted every 3 months (±1 month) via phone, email, or letter for 24 months or until the the overall censoring rate for survival reduces to a level identified in the SAP.

An End of Treatment visit should occur once a patient is to enter the long term follow up. This visit should occur approximately 30 days from the last dose of 177Lu-PSMA-617 or best supportive/best standard of care, but before the initiation of subsequent anti-cancer treatment, outside of what is allowed on study.

The planned enrollment for this study is 750 patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study population includes patients with progressive PSMA-positive mCRPC who received at least one novel androgen axis drug [NAAD] (such as enzalutamide or abiraterone) and were previously treated with 1 to 2 taxane regimens. Patients treated with only 1 prior taxane regimen are eligible if the patient is unwilling or the patient's physician deems the patient unsuitable to receive a second regimen.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 177Lu-PSMA-617 plus BS/BSC
Patients randomized to receive the investigational product will receive 7.4 GBq (±10%) 177Lu-PSMA-617 intravenously every 6 weeks (±1 week) for a maximum of 6 cycles. + Best supportive/best standard of care (BS/BSOC)
Drug: 177Lu-PSMA-617
Patients randomized to receive the investigational product will receive 7.4 GBq (±10%) 177Lu-PSMA-617 intravenously every 6 weeks (±1 week) for a maximum of 6 cycles. After 4 cycles, patients will be assessed for (1) evidence of response, (2) residual disease, and (3) tolerance to 177Lu-PSMA-617. If all 3 assessments are met the patient may receive an additional 2 cycles of 177Lu-PSMA-617.

Other: Best supportive/best standard of care
Best supportive/best standard of care as defined by the local investigator
Other Name: Comparator

BS/BSC alone
Patients randomized to this arm will receive best supportive/best standard of care (BS/BSOC) as determined by the investigator
Other: Best supportive/best standard of care
Best supportive/best standard of care as defined by the local investigator
Other Name: Comparator




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Every 6-8 weeks until end of treatment and every 3 months during long term follow up [up to 24 months ]
    Overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/standard of care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To qualify for enrollment, patients must meet the following criteria:

    1. Patients must have the ability to understand and sign an approved ICF.
    2. Patients must have the ability to understand and comply with all protocol requirements.
    3. Patients must be ≥18 years of age.
    4. Patients must have an ECOG performance status of 0 to 2.
    5. Patients must have a life expectancy >6 months.
    6. Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
    7. Patients must have a positive 68Ga-PSMA-11 PET/CT scan, as determined by the sponsor's central reader.
    8. 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).
    9. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone).
    10. Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if:

      1. The patient is not willing to receive a second taxane regimen, or
      2. The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation or intolerance).
    11. Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:

      1. 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.
      2. 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.
      3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 PCWG3 criteria, Scher et al 2016).
    12. Patients must have≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to beginning study therapy.
    13. Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.).
    14. Patients must have adequate organ function:

      1. Bone marrow reserve:

        • White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 10^9/L is equivalent to 2.5 x 10^3/µL and 2.5 x K/µL and 2.5 x 10^3/cumm and 2500/µL) OR absolute neutrophil count (ANC) ≥1.5 x 10^9/L (1.5 x 10^9/L is equivalent to 1.5 x 10^3/µL and 1.5 x K/µL and 1.5 x 10^3/cumm and 1500/µL)
        • Platelets≥ 100 x 10^9/L (100 x 10^9/L is equivalent to 100 x 10^3/µL and 100 x K/µL and 100 x 10^3/cumm and 100,000/µL)
        • Hemoglobin≥ 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L)
      2. Hepatic:

        • Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted
        • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases
      3. Renal:

        • Serum creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min
    15. Albumin >3.0 g/dL (3.0 g/dL is equivalent to 30 g/L)
    16. Patients on a stable bisphosphonate or denosumab regimen for ≥30 days prior to randomization are eligible.
    17. HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial.

      For patients who have partners of childbearing potential:

    18. Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 3 months after last study drug administration.

Exclusion Criteria:

  • Patients who meet any of the following criteria will be excluded from the study:

    1. Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation within 6 months prior to randomization. Previous PSMA-targeted radioligand therapy is not allowed.
    2. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of randomization.
    3. Any investigational agents within 28 days prior to day of randomization.
    4. Known hypersensitivity to the components of the study therapy or its analogs.
    5. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
    6. Transfusion within 30 days of randomization.
    7. 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).
    8. A superscan as seen in the baseline bone scan.
    9. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
    10. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
    11. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. Patients with adequately treated non-melanoma skin cancer, superficial bladder cancer and patients with prior history of malignancy who have been disease free for more than 3 years are eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511664


Contacts
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Contact: Richard Messmann, MD 765-476-1070 rmessmann@endocyte.com
Contact: Wendy Perez 317-608-0590 wperez@endocyte.com

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Locations
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United States, Arizona
HonorHealth Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer    480-882-5820    clinicaltrials@honorhealth.com   
Principal Investigator: Michael Gordon, MD         
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85719-1454
Contact: Annie Phinizy    520-694-2873    aphinizy@email.arizona.edu   
Principal Investigator: Hanni Babiker, MD         
United States, California
VA Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Karen Evangelisa    310-478-3711 ext 41399    karen.evangelista@va.gov   
Principal Investigator: Gholam Reza Berenji, MD         
UCLA Active, not recruiting
Los Angeles, California, United States, 90095-7370
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Shermeen Poushnejad    650-724-7662    shermeen@stanford.edu   
Principal Investigator: Sandhya (Sandy Srinivas, M.D.         
UCSF Medical Center at Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Lani Bradish    415-476-4616    Lani.Bradish@ucsf.edu   
Principal Investigator: Dr. Vadim Koahkin, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Dan Nguyen    720-848-6502    DAN.N.NGUYEN@UCDENVER.EDU   
Principal Investigator: Bennett Chin, MD         
United States, Connecticut
Yale Cancer Center, Clinical Trials Office Recruiting
New Haven, Connecticut, United States, 06519
Contact: Matthew Piscatelli    203-737-8076    shelby.decarlo@yale.edu   
Principal Investigator: Daniel Petrylak, MD         
United States, District of Columbia
Washington DC VA Medical Center, Nuclear Medicine Service Recruiting
Washington, District of Columbia, United States, 20422
Contact: Sharon Wiggs    202-754-8000 ext 57589    Sharon.Wiggs@va.gov   
Principal Investigator: Frank Liu, MD         
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Malesa Pereira    813-745-4090    malesa.pereira@moffitt.org   
Principal Investigator: Ghassan El-Haddad, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Study Coordinator    312-695-1301    cancertrials@northwestern.edu   
Principal Investigator: Alicia Morgans, MD         
United States, Indiana
Parkview Cancer Institute Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Tracy Thorne    260-266-9167    tracy.thorne@parkview.com   
Principal Investigator: Brian Chang, M.D.         
IU Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Marietta Moore    317-274-7477    marlmoor@iupui.edu   
Principal Investigator: Roberto Pili, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Cancer Center Research Recruiting
Iowa City, Iowa, United States, 52242
Contact: Kristin Gaimari Varner    319-384-5489    kristin-gaimari-varner@uiowa.edu   
Principal Investigator: Rohan Garje, M.D.         
Iowa VA Medical Center Recruiting
Iowa City, Iowa, United States, 52246
Contact: Veronica Howsare    319-354-6469    veronica-howsare@uiowa.edu   
Principal Investigator: Janet Pollard, MD         
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
Contact: Pamela Adkisson    502-629-2500    Pamela.adkisson@nortonhealthcare.org   
Principal Investigator: Arash Kalebasty, M.D.         
United States, Louisiana
Tulane Cancer Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Charlotte E Manogue       cmanogue@tulane.edu   
Principal Investigator: Oliver Sartor, MD         
United States, Maryland
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Michele Besche    410-328-8610    mbesche@umm.edu   
Principal Investigator: Amir Hussain, M.D.         
Chesapeake Urology Research Associates Recruiting
Towson, Maryland, United States, 21204
Contact: Angela Somers    443-471-5829    asomers@cua.md   
Principal Investigator: Ronald Tutrone Jr., MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Eileen Creaton    617-975-7432    ecreaton@bidmc.harvard.edu   
Principal Investigator: Glen Bubley, MD         
The Lank Center for Genitourinary Oncology Recruiting
Boston, Massachusetts, United States, 02215
Contact: Deanna M Hart    617-582-7334    deannam_hart@dfci.harvard.edu   
Principal Investigator: Lauren Harshman, M.D.         
United States, Michigan
VA Ann Arbor Healthcare System Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Brittany Pannecouk    734-845-3966    Brittany.Pannecouk@va.gov   
Principal Investigator: Benjamin Viglianti, MD         
University of Michigan Medical Center, Division of Nuclear Medicine Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Debra Dill    800-865-1125    canceranswerline@med.umich.edu   
Principal Investigator: Morand Piert, MD         
Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Kim Dobson    313-576-8749    dobsonk@karmanos.org   
Principal Investigator: Ulka Vaishampayan, MD         
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
John Cochran St. Louis Veterans Medical Center Recruiting
Saint Louis, Missouri, United States, 63106
Contact: Kelly Reno    314-289-7690    Kelly.Reno@va.gov   
Principal Investigator: Medhat Osman, MD         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110-1093
Contact: James Yun    314-362-8547    james.yun@wustl.edu   
Contact: Yun         
Principal Investigator: Jeff Michalski, MD         
St. Louis University Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Anna Hardy    314-268-5785    anna.hardy@health.slu.edu   
Principal Investigator: Medhat Osman, M.D.         
United States, Nebraska
GU Research Network/ Urology Cancer Center Recruiting
Omaha, Nebraska, United States, 68130
Contact: Tony Romero    402-690-3716    tromero@gucancer.com   
Principal Investigator: Luke Nordquist, MD         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Jewelle Villaflor    702-952-3400    jewelle.villaflor@usoncology.com   
Principal Investigator: Nicholas Vogelzang, MD         
United States, New Jersey
Regional Cancer Care Associates Recruiting
East Brunswick, New Jersey, United States, 08816
Contact: Tony Romero    402-697-2229    tromero@gucancer.com   
Principal Investigator: Bruno Fang, MD         
United States, New Mexico
New Mexico Oncology & Hematology Consultants Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Ezequiel Cambranis       ezequielc@nmohc.com   
Principal Investigator: Gregg E Franklin, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael Morris    646-422-4469      
Principal Investigator: Michael Morris, MD         
New York Presbyterian Hospital/Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Amy Hackett    646-962-9347    amh2027@med.cornell.edu   
Principal Investigator: Scott Tagawa, M.D.         
United States, North Carolina
Duke University School of Medicine, Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Julia Hurrelbrink    919-681-7460    julia.hurrelbrink@duke.edu   
Principal Investigator: Andrew Armstrong, M.D.         
United States, Ohio
Precision Cancer Research/ Dayton Physicians Network Recruiting
Kettering, Ohio, United States, 45409
Contact: Corie Tofstad    937-771-2287 ext 1657    ctofstad@daytonphysicians.com   
Principal Investigator: Charles L Bane, MD         
United States, Oregon
Oregon Health and Science University Nuclear Medicine Department Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Shaadi Tabatabaei    503-494-1080    trials@ohsu.edu   
Principal Investigator: Tomasz Beer, MD         
United States, Pennsylvania
Gettysburg Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Terry Burke    717-334-4033    terry@gettysburgoncology.com   
Contact: Vanessa Hardman Warner    717-334-4033    vwarner@gettysburgoncology.com   
Principal Investigator: Satish Shah, MD         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Karah Williams    215-955-0017    Karah.Williams@jefferson.edu   
Principal Investigator: Robert Den, MD         
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Jennifer Griffith    843-449-1010    jgriffith@curcmb.com   
Principal Investigator: Neal Shore, MD         
United States, Texas
Dallas VA Research Organization Recruiting
Dallas, Texas, United States, 75216
Contact: Angela James    214-857-3772    Angela.James3@VA.gov   
Principal Investigator: Ifrab Farukhi, MD         
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Michael Fulkerson    214-648-5984    Michael.Fulkerson@UTSouthwestern.edu   
Contact: Jagruti Patel    214-648-5983    Jagruti.Patel@UTSouthwestern.edu   
Principal Investigator: Rathan Subramaniam, MD         
Excel Diagnostics & Nuclear Oncology Center Active, not recruiting
Houston, Texas, United States, 77042
United States, Virginia
UVA Cancer Care Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Julio Torres    434-982-4110    JT4GS@hscmail.mcc.virginia.edu   
Principal Investigator: Robert Dreicer, M.D.         
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Andrew Bathan    206-215-3866    Andrew.Bathan@swedish.org   
Principal Investigator: Song Zhao, MD         
Belgium
Cliniques Universitaires Saint Luc Recruiting
Brussels, Belgium
Contact: Mrs. Anne-Marie Salumu Ekendji    32 2 764 35 46    salumu.ekendji@uclouvain.be   
Principal Investigator: Dr. Renaud Lhommel, M.D.         
Institut Jules Bordet Recruiting
Brussels, Belgium
Contact: Loubna Taraji-Schiltz    32 2 541 37 81    Loubna.Taraji-schiltz@bordet.be   
Principal Investigator: Dr. Carlos Artigas Guix, MD         
University Hospitals Leuven, Campus Gasthuisberg, Department of Nuclear Medicine Recruiting
Leuven, Belgium, 3000
Contact: Susan Berentsen    32 16 34 59 93    Susan.berentsen@uzleuven.be   
Principal Investigator: Dr. Benoit Beuselinck, MD         
Canada, British Columbia
BC Cancer - Vancouver Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Kim Nguyen Chi    604-877-6000    kchi@bccancer.bc.ca   
Principal Investigator: Kim Nguyen Chi, MD         
Canada, Ontario
London Health Sciences Centre, Division of Nuclear Medicine Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Sarah De Brabandere    519-685-8500 ext 56399    sarah.debrabandere@lhsc.on.ca   
Principal Investigator: David Laidley, MD         
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Michael Ong, M.D.    613-737-7700 ext 75051    mong@toh.ca   
Principal Investigator: Michael Ong, M.D.         
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Nesan Bandali    416-480-6100 ext 82139    Nesan.bandali@sunnybrook.ca   
Principal Investigator: Urban Emmenegger, M.D.         
Canada, Quebec
CHUM - Hotel Dieu Hospital Recruiting
Montréal, Quebec, Canada, H2X OA9
Contact: Amal Nadri    514-890-8000 ext 26074    amal.nadiri.chum@ssss.gouv.qc.ca   
Principal Investigator: Dr. Fred Saad, M.D.         
Jewish General Hospital Recruiting
Montréal, Quebec, Canada, H3T 1E2
Contact: Aline Mamo    514-340-8222    Aline.Mamo@ladydavis.ca   
Principal Investigator: Cristiano Ferrario, MD         
Hotel Dieu Hospital in Quebec Recruiting
Québec, Quebec, Canada, G1R2J6
Contact: Guillaume Bouvet    418-525-4444 ext 20897    Guillaume.bouvet@crchudequebec.ulaval.ca   
Principal Investigator: Jean-Mathieu Beauregard, MD         
Denmark
Aalborg University Hospital Klinik Kirurgi-Kræft Clinical Research Unit Department of Oncology Recruiting
Aalborg, Denmark
Contact: Eva Kanstrup Poulsen    45 97661288    evpo@rn.dk   
Principal Investigator: Dr. Mette Moe Kempel, MD         
Aarhus Universitetshospital Recruiting
Aarhus, Denmark
Contact: Simon Buus, MD    45 40465291    simon.buus@auh.rm.dk   
Principal Investigator: Dr Simon Buus, MD         
Rigshospitalet - University Hospital Copenhagen, Department of Oncology Recruiting
Copenhagen, Denmark
Contact: Erla Hrönn Valdimarsdóttir Nørgaard         
Contact    45 3545 5387    erla.hroenn.valdimarsdottir.noergaard.01@regionh.dk   
Principal Investigator: Dr. Peter Petersen, MD         
France
Bergonie Institute Recruiting
Bordeaux, France, 33076
Contact: Anne Cazeau    33 (55) 633 3321    a.cazeau@bordeaux.unicancer.fr   
Principal Investigator: Dr. Anne Cazeau, M.D.         
Center Jean Perrin Recruiting
Clermont-Ferrand, France
Contact: Emilie Villeneuve    (33) 4 73 27 80 05    Emilie.VILLENEUVE@clermont.unicancer.fr   
Principal Investigator: Dr. Hakim Mahammedi, MD         
Leon Berard Center Recruiting
Lyon, France
Contact: Pauline Linard    33 (0)4 26 55 68 42    pauline.linard@lyon.unicancer.fr   
Principal Investigator: Dr. Aude Flechon, M.D.         
Centre d'Investigations et de Recherche Clinique en Oncologie Hospital SAINT-LOUIS Recruiting
Paris, France
Contact: Kenza BENSARI    01 42 38 51 10    kenza.aoun-seghir@aphp.fr   
Contact: Soraya MERBAH    01 42 38 51 10    soraya.merbah@aphp.fr   
Principal Investigator: Dr. Stephanie Culine, MD         
Tenon Hospital Recruiting
Paris, France
Contact: Dr. Mathieu Gauthe, MD    33 1 56 01 65 56    Mathieu.gauthe@aphp.fr   
Principal Investigator: Dr. Mathieu Gauthe, MD         
Institute Claudius Regaud, Toulouse Cancer Research Center Recruiting
Toulouse, France
Contact: Marta DABEK    05 31 15 58 10    dabek.marta@iuct-oncopole.fr   
Principal Investigator: DR. Frederic Courbon, MD         
Gustave Roussy Oncology Institute Recruiting
Villejuif, France
Contact: Wilna Yeboah    33 1 42 11 64 41    wilna.yeboah@gustaveroussy.fr   
Principal Investigator: Dr. Karim Fizazi, M.D.         
Netherlands
The Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands, 1066
Contact: Mariëtte Kieft    020 512 1547    m.kieft@nki.nl   
Principal Investigator: Dr. Wouter Vogel, MD         
St. Antonius Hospital Recruiting
Nieuwegein, Netherlands
Contact: Jenneke Meutgeert    31-88 - 320 4723    j.meutgeert@antoniusziekenhuis.nl   
Contact: Petra Veen    31-88 - 320 6001    p.veen@antoniusziekenhuis.nl   
Principal Investigator: Dr. Jules Lavalaye, MD         
Radboud University Medical Center Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Michel de Groot    31 (0)24 366 72 43    Michel.deGroot@radboudumc.nl   
Principal Investigator: James Nagarajah, MD         
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands
Contact: Saskia van Amelsvoort    +31 88 75 590 07    S.vanAmelsvoort-vandeVorst@umcutrecht.nl   
Principal Investigator: Dr. Bart de Keizer, MD         
Puerto Rico
VA Caribbean Healthcare System Recruiting
San Juan, Puerto Rico, 00921
Contact: Marleni Pagan-Ramos    787 641-7582 ext 10149 or 10390    Marleni.Pagan-Ramos@va.gov   
Principal Investigator: Irma Molina-Vicenty, M.D.         
Sweden
Sahlgrenska University Hospital, Department of Oncology Recruiting
Gothenburg, Sweden
Contact: Jon Kindblom    +0 (46) 313427656    jon.kindblom@vgregion.se   
Principal Investigator: Dr. Jon Kindblom, M.D.         
Skane University Hospital Recruiting
Lund, Sweden
Contact: Ingrid Müchler    46 46 177064    Ingrid.Muchler@skane.se   
Principal Investigator: Dr. Anna Sundlov, MD         
Karolinska University Hospital Recruiting
Stockholm, Sweden, SE 17176
Contact: Enrique Castellanos, MD    (0046) 707 89 33 29    enrique.castellanos@sll.se   
Principal Investigator: Dr. Enrique Castellanos         
Norrlands Universitetssjukhus Recruiting
Umeå, Sweden
Contact: Camilla Thellenberg       Camilla.thellenberg@regionvasterbotten.se   
Contact    46907850000 (switch board)      
Principal Investigator: Dr. Anders Widmark, MD         
Uppsala University Hospital, Department of Oncology Recruiting
Uppsala, Sweden
Contact: Maria Wall    018 611 97 79    maria.wall@akademiska.se   
Principal Investigator: Dr. Silvia Johansson, MD         
United Kingdom
Institute of Cancer Research Recruiting
Sutton, Surrey, United Kingdom, SM2 5NG
Contact: Dr. Diletta Bianchini    +44 208 642 6011    Diletta.Bianchini@icr.ac.uk   
Principal Investigator: Dr. Johann de Bono         
Bristol Hematology & Oncology Center Recruiting
Bristol, United Kingdom, BS2 8ED
Contact: Vivienne Lee    +44 (117) 342 7764    Vivienne.Lee@UHBristol.nhs.uk   
Principal Investigator: Dr. Amit Bahl         
Beatson West of Scotland Cancer Center Recruiting
Glasgow, United Kingdom, G12 OYN
Contact: Robert Jones    0141 301 7000    r.jones@beatson.gla.ac.uk   
Principal Investigator: Dr. Robert Jones         
Royal Surrey County Hospital NHS Foundation Trust Recruiting
Guildford, United Kingdom
Contact: Edith Gallagher    01483 406612    edith.gallagher@nhs.net   
Principal Investigator: Dr. Carla Perna, MD         
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1 2PG
Contact: Daniel Garrett    0203 447 7241    daniel.garrett@nhs.net   
Principal Investigator: Dr. Heather Payne         
Royal Free London NHS Foundation Trust Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Sandra Marques    02077940500 ext 39659    s.marques@nhs.net   
Principal Investigator: Dr. Sarah Needleman, MD         
Guy's Hospital Recruiting
London, United Kingdom
Contact: Susie Slater    020 7188 12007    UrologyResearchTeam@gstt.nhs.uk   
Principal Investigator: Dr. Deborah Enting, MD         
St Bartholomew's Hospital, West Smithfield Recruiting
London, United Kingdom
Contact: Paul Hillman    020 346 57563    Paul.Hillman@bartshealth.nhs.uk   
Principal Investigator: Dr. Jonathan Shamash, MD         
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Fabiola Morales-Azofra    44 02381 204345    fabiola.morales-azofra@uhs.nhs.uk   
Principal Investigator: Dr. Simon Crabb, MD         
Sponsors and Collaborators
Endocyte
Investigators
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Study Director: Richard Messmann, MD Endocyte

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Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT03511664     History of Changes
Other Study ID Numbers: PSMA-617-01
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Endocyte:
mCRPC
177Lu-PSMA-617
PSMA-617
PSMA-11
radioligand therapy

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases