Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer (VISION)
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ClinicalTrials.gov Identifier: NCT03511664 |
Recruitment Status :
Completed
First Posted : April 30, 2018
Results First Posted : May 9, 2022
Last Update Posted : January 31, 2024
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Sponsor:
Endocyte
Information provided by (Responsible Party):
Endocyte
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Prostate Cancer |
Interventions |
Drug: 177Lu-PSMA-617 Other: Best supportive/best standard of care |
Enrollment | 831 |
Participant Flow
Recruitment Details | The study was conducted in 86 sites across 9 countries. Belgium (3); Canada (7); Denmark (3); France (6); Netherlands (4); Sweden (5); UK (9); US (45); Germany (4, for the sub-study only) |
Pre-assignment Details |
Arm/Group Title | 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | Best Supportive/Best Standard of Care (BS/BSOC) Alone |
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Arm/Group Description | 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 | Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator |
Period Title: Overall Study | ||
Started [1] | 551 | 280 |
FAS Safety Analysis Set | 529 | 205 |
Progression-Free Survival (PFS) Full Analysis Set (PFS-FAS) | 385 | 196 |
Response Evaluable Analysis Set | 319 | 120 |
Completed | 329 | 167 |
Not Completed | 222 | 113 |
Reason Not Completed | ||
Treatment ongoing | 49 | 5 |
Entered long-term follow-up | 140 | 50 |
Withdrawal by Subject | 29 | 53 |
Lost to Follow-up | 4 | 4 |
Physician Decision | 0 | 1 |
[1]
All randomized patients were included in the Full Analysis Set (FAS). Patients were included in the treatment arm to which they were randomized regardless of actual treatment received.
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Baseline Characteristics
Arm/Group Title | 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | Best Supportive/Best Standard of Care (BS/BSOC) Alone | Total | |
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Arm/Group Description | 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 | Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator | Total of all reporting groups | |
Overall Number of Baseline Participants | 551 | 280 | 831 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 551 participants | 280 participants | 831 participants | |
69.7 (7.4) | 70.5 (7.8) | 70.0 (7.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 551 participants | 280 participants | 831 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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Male |
551 100.0%
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280 100.0%
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831 100.0%
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Race/Ethnicity, Customized
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 551 participants | 280 participants | 831 participants |
White | 486 | 235 | 721 | |
Black or African American | 34 | 21 | 55 | |
Asian | 9 | 11 | 20 | |
Other | 2 | 0 | 2 | |
Missing | 20 | 13 | 33 | |
[1]
Measure Description: Race 'Other' included Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native and more than one race reported.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Novartis Pharmaceuticals |
Phone: | 862-778-8300 |
EMail: | Novartis.email@novartis.com |
Publications of Results:
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, Pérez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. PMID:34161051
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Endocyte |
ClinicalTrials.gov Identifier: | NCT03511664 |
Other Study ID Numbers: |
PSMA-617-01 2018-000459-41 ( EudraCT Number ) CAAA617A12301 ( Other Identifier: Novartis ) |
First Submitted: | April 13, 2018 |
First Posted: | April 30, 2018 |
Results First Submitted: | April 12, 2022 |
Results First Posted: | May 9, 2022 |
Last Update Posted: | January 31, 2024 |