Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2013
Phase II study of Lutetium-177-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 for metastatic castration-resistant prostate cancer.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 206 papers, 6 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.
A Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Androgen-Independent Prostate Cancer
Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma
Who cites it
206 citing papers in PubMed, 6 syntheses or guidelines pooled it, 420 citations in OpenAlex.
- Dosimetry of [Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2024Pooled it
- Joint EANM/SNMMI procedure guideline for the use ofEuropean journal of nuclear medicine and molecular imaging · 2023Guideline
- Radiopharmaceuticals for PET and SPECT Imaging: A Literature Review over the Last Decade.International journal of molecular sciences · 2022Pooled it
- Metastatic castration-resistant prostate cancer: Academic insights and perspectives through bibliometric analysis.Medicine · 2020Pooled it
- Third-line treatment andEuropean journal of nuclear medicine and molecular imaging · 2018Pooled it
- Lutetium-177-labelled anti-prostate-specific membrane antigen antibody and ligands for the treatment of metastatic castrate-resistant prostate cancer: a systematic review and meta-analysis.Prostate cancer and prostatic diseases · 2017Pooled it
- Tumor and Organ Dose Estimates fromJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026Trial
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- Imaging Patients with Metastatic Castration-Resistant Prostate Cancer UsingJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2019Trial
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- Comparison of Prostate-Specific Membrane Antigen-Based 18F-DCFBC PET/CT to Conventional Imaging Modalities for Detection of Hormone-Naïve and Castration-Resistant Metastatic Prostate Cancer.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2016Trial
- Circulating tumor cells from prostate cancer patients interact with E-selectin under physiologic blood flow.PloS one · 2013Trial
- A Phase I Dose-Escalation/Expansion Study of Fractionated-Dose and Multiple-Cycle Anti-PSMA-Targeted α-Emitter 225Ac-J591 in Patients with Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Effects of androgen receptor signaling inhibitors on absorbed doses in mCRPC patients undergoing [European journal of nuclear medicine and molecular imaging · 2026Article
- PROQURE-I: a phase I study adding concurrent [European journal of nuclear medicine and molecular imaging · 2026Article
- Theranostic Potential ofCancers · 2026Article
- PET Imaging of Accessible Prostate-Specific Membrane Antigen Reveals Dose-Dependent and Tumor Burden-Driven Variability.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026Article
146 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
13 authors at 3 institutions in 1 country.
Funding
Abstract
purposeTo assess the efficacy of a single infusion of radiolabeled anti-prostate-specific membrane antigen (PSMA) monoclonal antibody J591 (lutetium-177; (177)Lu) by prostate-specific antigen (PSA) decline, measurable disease response, and survival. EXPERIMENTAL
designIn this dual-center phase II study, two cohorts with progressive metastatic castration-resistant prostate cancer received one dose of (177)Lu-J591 (15 patients at 65 mCi/m(2), 17 at 70 mCi/m(2)) with radionuclide imaging. Expansion cohort (n = 15) received 70 mCi/m(2) to verify response rate and examine biomarkers.
resultsForty-seven patients who progressed after hormonal therapies (55.3% also received prior chemotherapy) received (177)Lu-J591. A total of 10.6% experienced ≥50% decline in PSA, 36.2% experienced ≥30% decline, and 59.6% experienced any PSA decline following their single treatment. One of 12 with measurable disease experienced a partial radiographic response (8 with stable disease). Sites of prostate cancer metastases were targeted in 44 of 47 (93.6%) as determined by planar imaging. All experienced reversible hematologic toxicity, with grade 4 thrombocytopenia occurring in 46.8% (29.8% received platelet transfusions) without significant hemorrhage. A total of 25.5% experienced grade 4 neutropenia, with one episode of febrile neutropenia. The phase I maximum tolerated dose (70 mCi/m(2)) resulted in more 30% PSA declines (46.9% vs. 13.3%, P = 0.048) and longer survival (21.8 vs. 11.9 months, P = 0.03), but also more grade 4 hematologic toxicity and platelet transfusions. No serious nonhematologic toxicity occurred. Those with poor PSMA imaging were less likely to respond.
conclusionA single dose of (177)Lu-J591 was well tolerated with reversible myelosuppression. Accurate tumor targeting and PSA responses were seen with evidence of dose response. Imaging biomarkers seem promising.
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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.