Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
NCT ID: NCT03511664
Last Updated: 2025-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
861 participants
INTERVENTIONAL
2018-05-29
2023-12-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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177Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)
Patients randomized to receive the investigational product received 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) might be used
177Lu-PSMA-617
Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles. After 4 cycles, patients were assessed for (1) evidence of response, (2) residual disease, and (3) tolerance to 177Lu-PSMA-617. If all 3 assessments were met the patient might received an additional 2 cycles of 177Lu-PSMA-617.
Best supportive/best standard of care
Best supportive/best standard of care as defined by the local investigator
Best supportive/best standard of care (BS/BSOC) alone
Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
Best supportive/best standard of care
Best supportive/best standard of care as defined by the local investigator
Interventions
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177Lu-PSMA-617
Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles. After 4 cycles, patients were assessed for (1) evidence of response, (2) residual disease, and (3) tolerance to 177Lu-PSMA-617. If all 3 assessments were met the patient might received an additional 2 cycles of 177Lu-PSMA-617.
Best supportive/best standard of care
Best supportive/best standard of care as defined by the local investigator
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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Endocyte
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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HonorHealth Research Institute
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
University of California Los Angeles, Nuclear Medicine
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Washington DC VA Medical Center, Nuclear Medicine Service
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Iowa City VA Medical Center
Iowa City, Iowa, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Tulane Medical Center, Tulane Cancer Center
New Orleans, Louisiana, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Chesapeake Urology Associates (CUA) P.A.
Towson, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
University of Michigan Hospitals
Ann Arbor, Michigan, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Saint Louis University Hospital
St Louis, Missouri, United States
VA St. Louis Health Care System - John Cochran
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada - Twain Office
Las Vegas, Nevada, United States
Regional Cancer Care Associates, Central Jersey Division
East Brunswick, New Jersey, United States
New Mexico Oncology Hematology Consultants Ltd., New Mexico Cancer Center
Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
Duke University Medical Center, Duke Cancer Center
Durham, North Carolina, United States
Greater Dayton Cancer Center
Kettering, Ohio, United States
Oregon Health and Science University, Nuclear Medicine
Portland, Oregon, United States
Pennsylvania Cancer Specialists & Research Institute
Gettysburg, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
VA North Texas Health Care System, Nuclear Medicine Service
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, United States
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States
Swedish Cancer Institute Research
Seattle, Washington, United States
Jules Bordet Institute
Brussels, , Belgium
Saint Luc University Hospital
Brussels, , Belgium
University Hospitals Leuven, Campus Gasthuisberg, Department of Nuclear Medicine
Leuven, , Belgium
BC Cancer - Vancouver
Vancouver, British Columbia, Canada
London Health Sciences Centre, Division of Nuclear Medicine
London, Ontario, Canada
Ottawa Hospital, Cancer Center
Ottawa, Ontario, Canada
Sunnybrook Research Institute, Odette Cancer Center
Toronto, Ontario, Canada
CHUM - University Hospital of Montreal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU of Quebec - Laval University
Québec, , Canada
Aalborg University Hospital, Oncology Department
Aalborg, , Denmark
Aarhus University Hospital, Department of Oncology
Aarhus, , Denmark
Rigshospitalet - University Hospital Copenhagen, Department of Oncology
Copenhagen, , Denmark
Bergonie Institute
Bordeaux, , France
Center Jean Perrin
Clermont-Ferrand, , France
Leon Berard Center
Lyon, , France
Saint-Louis Hospital
Paris, , France
Tenon Hospital
Paris, , France
Institute Claudius Regaud, Toulouse Cancer Research Center
Toulouse, , France
Gustave Roussy Oncology Institute
Villejuif, , France
University Hospital Essen, Clinic for Nuclear Medicine
Essen, , Germany
Hospital rechts der Isar, Department of Nuclear Medicine
Munich, , Germany
University Hospital Muenster, Department of Nuclear Medicine
Münster, , Germany
Rostock University Medical Center, Clinic and Polyclinic for Nuclear Medicine
Rostock, , Germany
The Netherlands Cancer Institute
Amsterdam, , Netherlands
St. Antonius Hospital
Nieuwegein, , Netherlands
Radboud University Medical Center (Radboudumc)
Nijmegen, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
VA Caribbean Healthcare System
San Juan, , Puerto Rico
Sahlgrenska University Hospital, Department of Oncology
Gothenburg, , Sweden
Skane University Hospital - Barngatan, Clinical Trials Unit
Lund, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Norrlands University Hospital, Cancer Center
Umeå, , Sweden
Uppsala University Hospital, Department of Oncology
Uppsala, , Sweden
Bristol Hematology & Oncology Center
Bristol, , United Kingdom
Beatson West of Scotland Cancer Center
Glasgow, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
Guy's Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Institute of Cancer Research
Sutton, , United Kingdom
Countries
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References
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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.
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.
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.
Herrmann K, Rahbar K, Eiber M, Sparks R, Baca N, Krause BJ, Lassmann M, Jentzen W, Tang J, Chicco D, Klein P, Blumenstein L, Basque JR, Kurth J. Renal and Multiorgan Safety of 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer in the VISION Dosimetry Substudy. J Nucl Med. 2024 Jan 2;65(1):71-78. doi: 10.2967/jnumed.123.265448.
Kuo PH, Yoo DC, Avery R, Seltzer M, Calais J, Nagarajah J, Weber WA, Fendler WP, Hofman MS, Krause BJ, Brackman M, Kpamegan E, Ghebremariam S, Benson T, Catafau AM, Kendi AT. A VISION Substudy of Reader Agreement on 68Ga-PSMA-11 PET/CT Scan Interpretation to Determine Patient Eligibility for 177Lu-PSMA-617 Radioligand Therapy. J Nucl Med. 2023 Aug;64(8):1259-1265. doi: 10.2967/jnumed.122.265077. Epub 2023 May 25.
Sartor O, de Bono J, Chi KN, Fizazi K, Herrmann K, Rahbar K, Tagawa ST, Nordquist LT, Vaishampayan N, El-Haddad G, Park CH, Beer TM, Armour A, Perez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ; VISION Investigators. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322. Epub 2021 Jun 23.
Armstrong AJ, Sartor O, de Bono J, Chi K, Fizazi K, Krause BJ, Herrmann K, Rahbar K, Tagawa ST, Saad F, Beer TM, Wu J, Mirante O, Morris MJ. Association of Declining Prostate-specific Antigen Levels with Clinical Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer Receiving [177Lu]Lu-PSMA-617 in the Phase 3 VISION Trial. Eur Urol. 2024 Dec;86(6):552-562. doi: 10.1016/j.eururo.2024.08.021. Epub 2024 Sep 5.
Chi KN, Armstrong AJ, Krause BJ, Herrmann K, Rahbar K, de Bono JS, Adra N, Garje R, Michalski JM, Kempel MM, Fizazi K, Morris MJ, Sartor O, Brackman M, DeSilvio M, Wilke C, Holder G, Tagawa ST. Safety Analyses of the Phase 3 VISION Trial of [177Lu]Lu-PSMA-617 in Patients with Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2024 Apr;85(4):382-391. doi: 10.1016/j.eururo.2023.12.004. Epub 2024 Jan 6.
Herrmann K, Gafita A, de Bono JS, Sartor O, Chi KN, Krause BJ, Rahbar K, Tagawa ST, Czernin J, El-Haddad G, Wong CC, Zhang Z, Wilke C, Mirante O, Morris MJ, Fizazi K. Multivariable models of outcomes with [177Lu]Lu-PSMA-617: analysis of the phase 3 VISION trial. EClinicalMedicine. 2024 Oct 4;77:102862. doi: 10.1016/j.eclinm.2024.102862. eCollection 2024 Nov.
Kuo PH, Morris MJ, Hesterman J, Kendi AT, Rahbar K, Wei XX, Fang B, Adra N, Garje R, Michalski JM, Chi K, de Bono J, Fizazi K, Krause B, Sartor O, Tagawa ST, Ghebremariam S, Brackman M, Wong CC, Catafau AM, Benson T, Armstrong AJ, Herrmann K. Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in Metastatic Castration-resistant Prostate Cancer Following 177Lu-PSMA-617 (VISION Trial). Radiology. 2024 Aug;312(2):e233460. doi: 10.1148/radiol.233460.
Morris MJ, de Bono J, Nagarajah J, Sartor O, Wei XX, Nordquist LT, Koshkin VS, Chi KN, Krause BJ, Herrmann K, Rahbar K, Vickers A, Mirante O, Ghouse R, Fizazi K, Tagawa ST. Correlation analyses of radiographic progression-free survival with clinical and health-related quality of life outcomes in metastatic castration-resistant prostate cancer: Analysis of the phase 3 VISION trial. Cancer. 2024 Oct 15;130(20):3426-3435. doi: 10.1002/cncr.35438. Epub 2024 Jun 21.
Sundlov A, Sjogreen-Gleisner K. Peptide Receptor Radionuclide Therapy - Prospects for Personalised Treatment. Clin Oncol (R Coll Radiol). 2021 Feb;33(2):92-97. doi: 10.1016/j.clon.2020.10.020. Epub 2020 Nov 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-000459-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAAA617A12301
Identifier Type: OTHER
Identifier Source: secondary_id
PSMA-617-01
Identifier Type: -
Identifier Source: org_study_id
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