Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023
FDA Approval Summary: Lutetium Lu 177 Vipivotide Tetraxetan for Patients with Metastatic Castration-Resistant Prostate Cancer.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03511664 (VISION), which is not on this map. Cited by 124 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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)
Who cites it
124 citing papers in PubMed, 3 syntheses or guidelines pooled it, 208 citations in OpenAlex.
- Liver Background Uptake of Prostate-specific Membrane Antigen-targeted PET Radiotracers: A Systematic Review and Meta-Analysis.Radiology. Imaging cancer · 2026Pooled it
- The efficacy and safety of cabazitaxel in the treatment of metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis based on randomized controlled trials.Frontiers in pharmacology · 2025Pooled it
- Pooled it
- Efficacy, toxicity, and clinical outcomes of 177Lu-PSMA-617 radioligand therapy at 5.5 GBq per cycle in patients with advanced castration-resistant prostate cancer: a prospective, single arm, phase II study.European journal of nuclear medicine and molecular imaging · 2026Trial
- Preliminary evaluation of a novel PSMA-targeting radiopharmaceutical [European journal of nuclear medicine and molecular imaging · 2025Trial
- PSMA-targeted radioligand therapy in prostate cancer: evidence hierarchy, platform maturity of ¹⁷⁷Lu-PSMA-617, and the clinical differentiation challenge for emerging radionuclides.Annals of nuclear medicine · 2026Review
- Recent advances in PSMA therapy - from beta to alpha.Annals of nuclear medicine · 2026Review
- Efficacy and outcomes of [European journal of nuclear medicine and molecular imaging · 2026Article
- Survival Outcomes With Lu-177 PSMA by Treatment Line and Taxane Sequencing in Prostate Cancer.JAMA network open · 2026Article
- Overall Survival with [Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026Article
- Systematic profiling of tumor-associated antigen expression for antibody-drug conjugate in prostate cancer.Prostate cancer and prostatic diseases · 2026Article
- 177 Lu-PSMA for prostate cancer: progress, challenges and future perspectives.Asian journal of andrology · 2026Review
- An assessment of time toxicity in patients receiving [177Lu]Lu-PSMA-617 for metastatic castration-resistant prostate cancer.The oncologist · 2026Article
- PROQURE-I: a phase I study adding concurrent [European journal of nuclear medicine and molecular imaging · 2026Article
- Balancing Stability and Payload Release in Glutathione-Responsive PROTAC Prodrugs Targeting Prostate Cancer.JACS Au · 2026Article
- FDA-Approved Drugs Containing Amide Functionality in the Last Five Years (2021-2025): Pharmaceutical Use, Trends and Synthetic Approaches.Medicines (Basel, Switzerland) · 2026Review
- The Prognostic Value ofAnnals of nuclear medicine · 2026Article
- Enhanced Antitumor Efficacy ofInternational journal of radiation oncology, biology, physics · 2026Article
- A Review of Approaches to the Synthesis of DCL-Based Prostate-Specific Membrane Antigen Ligands.International journal of molecular sciences · 2026Review
- Prostate Cancer Biomarkers with a Focus on Galectin-3: Emerging Clinical and Therapeutic Implications.Current oncology (Toronto, Ont.) · 2026Review
64 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 2 institutions in 1 country.
Funding
Abstract
On March 23, 2022, the FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, also known as 177Lu-PSMA-617) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The recommended 177Lu-PSMA-617 dose is 7.4 gigabecquerels (GBq; 200 mCi) intravenously every 6 weeks for up to six doses, or until disease progression or unacceptable toxicity. The FDA granted traditional approval based on VISION (NCT03511664), which was a randomized (2:1), multicenter, open-label trial that assessed the efficacy and safety of 177Lu-PSMA-617 plus best standard of care (BSoC; n = 551) or BSoC alone (n = 280) in men with progressive, PSMA-positive mCRPC. Patients were required to have received ≥1 androgen receptor pathway inhibitor, and one or two prior taxane-based chemotherapy regimens. There was a statistically significant and clinically meaningful improvement in overall survival (OS), with a median OS of 15.3 months in the 177Lu-PSMA-617 plus BSoC arm and 11.3 months in the BSoC arm, respectively (HR: 0.62; 95% confidence interval: 0.52-0.74; P < 0.001). The most common adverse reactions (≥20%) occurring at a higher incidence in patients receiving 177Lu-PSMA-617 were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. The most common laboratory abnormalities that worsened from baseline in ≥30% of patients receiving 177Lu-PSMA-617 were decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium. This article summarizes the FDA review of data supporting traditional approval of 177Lu-PSMA-617 for this indication.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.