drugset / Trial / NCT03511664
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-05-29
- Primary completion
- 2021-01-27
- Completion
- 2023-12-14
Outcome
Met primary endpoint
registry p < 0.001; Hazard Ratio (HR) 0.40 (99.2% CI 0.29 to 0.57); Log Rank NCT03511664 ↗
registry MEDIAN Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC): Primary OS Analysis: 15.3 (14.2 to 16.9) Months NCT03511664 ↗
registry p <0.001; Hazard Ratio (HR) 0.62 (95% CI 0.52 to 0.74); Log Rank NCT03511664 ↗
release “VISION trial, where patients with pre-treated PSMA-positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in risk of death” novartis.com ↗
release “both alternate primary endpoints of overall survival and radiographic progression free survival were met” novartis.com ↗
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- 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, 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-PSMA-617 | Other / unclassified | 7400 mbq | Intravenous |