Clinical trial NCT03511664: Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Metastatic castration-resistant prostate cancer
mCRPC
177Lu-PSMA-617
PSMA-617
PSMA-11
radioligand therapy
Lead sponsor: Endocyte
Sponsor class: INDUSTRY
First posted: 2018-04-30
Enrollment: 861
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in the Main Study were randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus BSC/BSoC or BSC/BSoC only. The sub-study was conducted in a non-randomized cohort (AAA617+ BSC/BSoC)
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone.

Detailed description: The study for each participant consisted of a Screening period, a Treatment period and a Follow-up period.

Sub-study A dosimetry, PK and ECG sub-study was conducted in a non-randomized cohort (AAA617+BSC/BSoC) of 30 patients at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Aside from additional assessments to collect data for dosimetry, PK, urinary metabolites and ECG, patients in the sub-study were screened for eligibility, treated and followed up similarly to the AAA617+BSC/BSoC (investigational arm) patients in the main study.

Screening and randomization:

During the screening period of up to 28 days before starting randomized treatment, each participant was assessed for PSMA positivity by gallium (68Ga) gozetotide imaging PET/scan per the pre-defined read rules, by the Sponsor's central reader. Only patients with PSMA-positive metastatic PC and meeting all other inclusion/exclusion criteria were randomized in a 2:1 ratio to receive either 177Lu-PSMA-617 plus BSC/BSoC or BSC/BSoC only. Randomized patients were stratified on the following factors: LDH level (=\< or \> 260 UI/L), presence of liver metastases (Yes or No), eastern cooperative oncology group (ECOG) score (0-1 or 2) and inclusion of NAAD in the BSC/BSoC (at time of randomization (Yes or No)). Protocol- specified BSC/BSoC for each patient was initiated by the investigating physician prior to patient randomization and maintained throughout the study. On-study changes to BSC/BSoC were allowed and at the discretion of the investigating physician.

Randomized treatment:

"Randomized treatment" in this study refers to AAA617+BSC/BSoC (investigational arm) and BSC/BSoC only (control arm). For the sub-study, "study treatment" refers to AAA617+BSC/BSoC (also referred to as the investigational arm), as no randomization occurred in the sub-study. When discussing aspects of the study which are applicable to both the main and sub-study, the term 'randomized treatment' will be used throughout this document. The term 'study treatment' will be used only when specifically referring to the sub-study.

Patients randomized to the investigational arm began AAA617 dosing within 28 days of randomization. These patients received BSC/BSoC and 7.4 GBq (+/-10%) AAA617 once every 6 weeks (+/- 1 week) for a maximum of 6 cycles.

After the Cycle 4 treatment and prior to Cycle 5 treatment, the Investigator had to determine if:

* The patient showed evidence of response (i.e. radiological, PSA, clinical benefit)
* The patient had signs of residual disease on CT with contrast/MRI or bone scan
* The patient had shown good tolerance to the AAA617 treatment

If the patient met all of the criteria above and agreed to continue with additional treatment of AAA617 the investigator could administer a further 2 cycles. A maximum of 6 cycles of radioligand therapy was allowed. If the patient did not meet any of the criteria or did not agree to additional AAA617 treatment, then no additional doses of AAA617 were administered after Cycle 4. After the last cycle of AAA617, patients continued BSC/BSoC alone, as long as the investigator felt they were clinically benefiting or until they required a treatment regimen not allowed in this study. For both treatment arms, the cycle duration for Cycle 1-6 was 6 weeks and for Cycle 7 and beyond, 12 weeks. From Cycle 7 onwards, all patients from both treatment arms only received BSC/BSoC.

End of treatment:

An End of Treatment (EOT) visit was scheduled approximately 30 days after the last dose of AAA617 or the date of the BSC/BSoC end of treatment decision (whichever occurred later), but before the initiation of subsequent anti-cancer treatment, outside of what was allowed on study. Once a patient discontinued the randomized treatment part of the study for any reason, an EOT visit was scheduled.

Long-term follow-up:

Patients on the active part of the study at the time of the final analysis of OS had an EOT visit at the next planned visit after implementation of V5.0/5.1 of the protocol and moved into long-term follow-up, unless they specifically withdrew consent from long-term follow-up of the study.

Patients who consented to be followed for long-term status updates, entered the long-term follow-up period after the EOT visit. The long-term follow-up period included the collection of rPFS (if the patient discontinued for reasons other than radiographic progression), OS, information about new treatments along with the patient's response to these treatments, AE assessment, and results of hematology and chemistry testing. During the follow-up, patients were contacted every 3 months (+/-1 month) via phone, email, or letter until a long-term follow-up study became available, until death or until withdrawal of consent, whichever occurred first.

Eligibility criteria: Inclusion Criteria:

1. Patients must have the ability to understand and sign an approved informed consent form (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 Eastern Cooperative Oncology Group (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 be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive, and eligible as determined by the sponsor's central reader.
8. Patients must have a castrate level of serum/plasma 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: a. The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation, intolerance, etc.).
11. Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:

    1. Serum/plasma 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:

    a. Bone marrow reserve:
    * White blood cell (WBC) count \>= 2.5 x 10\^9/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) b. 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 c. Renal:
    * Serum/plasma 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) \[Inclusion #16 has been removed\]

17. HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial.

18. For patients who have partners of childbearing potential: 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 6 months after last study drug administration.

19. The best standard of care/ best supportive care options planned for this patient:

1. Are allowed by the protocol
2. Have been agreed to by the treating investigator and patient
3. Allow for the management of the patient without 177Lu-PSMA-617

Exclusion Criteria:

1. Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. 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 for the sole purpose of making a subject eligible for study inclusion.
7. Patients with a history of Central Nervous System (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, known 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. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are patients with adequately treated non-melanoma skin cancer, superficial bladder cancer.

Primary outcomes:
measure: Radiographic Progression-free Survival (rPFS)
timeFrame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Overall Survival (OS)
timeFrame: From date of randomization until date of death from any cause, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) and up to 66 months (Final Analysis cut-off date = 14-Dec-2023)
Secondary outcomes:
measure: Number of Participants With Randomized/Study Treatment-emergent Adverse Events (TEAE)
timeFrame: From randomization till 30 days safety follow-up, assessed up to 66 months (Final Analysis cut-off date = 14-Dec-2023)
measure: Overall Response Rate (ORR)
timeFrame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Disease Control Rate (DCR)
timeFrame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Duration of Response (DOR)
timeFrame: From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Time to First Symptomatic Skeletal Event (SSE)
timeFrame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Progression-free Survival (PFS)
timeFrame: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Best Percentage Change From Baseline in Prostate-specific Antigen (PSA) Level
timeFrame: From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Percentage of Participants Achieving Prostate-specific Antigen (PSA) Response
timeFrame: From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Prostate-specific Antigen 80 (PSA80) Response
timeFrame: From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Duration of PSA Response
timeFrame: From date of first documented PSA response till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Best Percentage Change From Baseline in Alkaline Phosphatase (ALP) Level
timeFrame: From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Best Percentage Change From Baseline in Lactate Dehydrogenase (LDH) Level
timeFrame: From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Time to Worsening in BPI-SF Pain Intensity Scale
timeFrame: From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Time to Improvement After Worsening in BPI-SF Pain Intensity Scale
timeFrame: From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Time to Worsening in BPI-SF Pain Interference Scale
timeFrame: From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Time to Improvement After Worsening in BPI-SF Pain Interference Scale
timeFrame: From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Time to Worsening in BPI-SF Worst Pain Intensity Scale (Time to Disease Related Pain)
timeFrame: From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Intensity Scale
timeFrame: Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)
measure: Change From Baseline in BPI-SF (Brief-Pain Inventory - Short Form) Pain Interference Scale
timeFrame: Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)
measure: Time to Worsening in FACT-P Total Score
timeFrame: From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Change From Baseline in FACT-P (Functional Assessment of Cancer Therapy - Prostate) Total Score
timeFrame: Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)
measure: Time to Worsening in EQ-5D-5L Utility Score
timeFrame: From date of randomization until date of End of Treatment (EoT), assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score
timeFrame: Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)
measure: Change From Baseline in the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) EQ-VAS
timeFrame: Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)
measure: Number of Participants Hospitalized as In-patient
timeFrame: From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Duration of Time in Hospital Following 177Lu-PSMA-617 Administration
timeFrame: From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Concomitant Drug Use for Health Economics Analysis
timeFrame: From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
measure: Therapeutic Interventions for Health Economics Analysis
timeFrame: From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles, Nuclear Medicine
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Washington DC VA Medical Center, Nuclear Medicine Service
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Iowa City
country: United States
facility: Iowa City VA Medical Center
state: Iowa
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Medical Center, Tulane Cancer Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Cancer Center
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Associates (CUA) P.A.
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: VA St. Louis Health Care System - John Cochran
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: XCancer Omaha / Urology Cancer Center
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Twain Office
state: Nevada
city: East Brunswick
country: United States
facility: Regional Cancer Care Associates, Central Jersey Division
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants Ltd., New Mexico Cancer Center
state: New Mexico
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center, Duke Cancer Center
state: North Carolina
city: Kettering
country: United States
facility: Greater Dayton Cancer Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University, Nuclear Medicine
state: Oregon
city: Gettysburg
country: United States
facility: Pennsylvania Cancer Specialists & Research Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Dallas
country: United States
facility: VA North Texas Health Care System, Nuclear Medicine Service
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Excel Diagnostics & Nuclear Oncology Center
state: Texas
city: Charlottesville
country: United States
facility: Emily Couric Clinical Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute Research
state: Washington
city: Brussels
country: Belgium
facility: Jules Bordet Institute
city: Brussels
country: Belgium
facility: Saint Luc University Hospital
city: Leuven
country: Belgium
facility: University Hospitals Leuven, Campus Gasthuisberg, Department of Nuclear Medicine
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre, Division of Nuclear Medicine
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital, Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute, Odette Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: CHUM - University Hospital of Montreal
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Quebec
country: Canada
facility: CHU of Quebec - Laval University
city: Aalborg
country: Denmark
facility: Aalborg University Hospital, Oncology Department
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Oncology
city: Copenhagen
country: Denmark
facility: Rigshospitalet - University Hospital Copenhagen, Department of Oncology
city: Bordeaux
country: France
facility: Bergonie Institute
city: Clermont-Ferrand
country: France
facility: Center Jean Perrin
city: Lyon
country: France
facility: Leon Berard Center
city: Paris
country: France
facility: Saint-Louis Hospital
city: Paris
country: France
facility: Tenon Hospital
city: Toulouse
country: France
facility: Institute Claudius Regaud, Toulouse Cancer Research Center
city: Villejuif
country: France
facility: Gustave Roussy Oncology Institute
city: Essen
country: Germany
facility: University Hospital Essen, Clinic for Nuclear Medicine
city: Muenster
country: Germany
facility: University Hospital Muenster, Department of Nuclear Medicine
city: Munich
country: Germany
facility: Hospital rechts der Isar, Department of Nuclear Medicine
city: Rostock
country: Germany
facility: Rostock University Medical Center, Clinic and Polyclinic for Nuclear Medicine
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center (Radboudumc)
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Department of Oncology
city: Lund
country: Sweden
facility: Skane University Hospital - Barngatan, Clinical Trials Unit
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Umea
country: Sweden
facility: Norrlands University Hospital, Cancer Center
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Department of Oncology
city: Bristol
country: United Kingdom
facility: Bristol Hematology & Oncology Center
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Center
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: Institute of Cancer Research
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Iravani A, Violet J, Azad A, Hofman MS. Lutetium-177 prostate-specific membrane antigen (PSMA) theranostics: practical nuances and intricacies. Prostate Cancer Prostatic Dis. 2020 Mar;23(1):38-52. doi: 10.1038/s41391-019-0174-x. Epub 2019 Oct 8.
citation: Chi KN, Yip SM, Bauman G, Probst S, Emmenegger U, Kollmannsberger CK, Martineau P, Niazi T, Pouliot F, Rendon R, Hotte SJ, Laidley DT, Saad F. 177Lu-PSMA-617 in Metastatic Castration-Resistant Prostate Cancer: A Review of the Evidence and Implications for Canadian Clinical Practice. Curr Oncol. 2024 Mar 7;31(3):1400-1415. doi: 10.3390/curroncol31030106.
citation: Fizazi K, Herrmann K, Krause BJ, Rahbar K, Chi KN, Morris MJ, Sartor O, Tagawa ST, Kendi AT, Vogelzang N, Calais J, Nagarajah J, Wei XX, Koshkin VS, Beauregard JM, Chang B, Ghouse R, DeSilvio M, Messmann RA, de Bono J. Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 Jun;24(6):597-610. doi: 10.1016/S1470-2045(23)00158-4.
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