Evidence map›Paper›PMID 42080618›Full record

Observational studyClinical nuclear medicine2026

Outcome and Safety of Radioligand Therapy With [ 161 Tb]Tb-PSMA-617 After Re-Progression in mCRPC Patients Previously Treated With [ 177 Lu]Lu-PSMA-617.

Florian Rosar, Caroline Burgard, Sophia Phuong Thao Hoang, Arne Blickle, Mark Bartholomä, Stephan Maus, Connor Hein, Moritz B Bastian, Tilman Speicher, Andrea Schaefer-Schuler and 1 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Clinical nuclear medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04833517 (REALITY Study), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT04833517 unknown statusnot on this map

REALITY Study: Analysis of a Prospective REgistry to Assess Outcome and Toxicity of Targeted RadionucLide TherapY in Patients With mCRPC in Clinical Routine.

Typeobservational_patient_registrySponsorUniversität des SaarlandesRan2016 to 2025Enrolled500ConditionsProstate Cancer Metastatic, Castration Resistant Prostatic Cancer, Advanced Prostate Carcinoma
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Efficacy and safety of [Frontiers in medicine · 2026
    Pooled it
  2. Organ and tumor dosimetry of [European journal of nuclear medicine and molecular imaging · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Florian RosarDepartment of Nuclear Medicine, Saarland University-Medical Center, Homburg, Germany.ORCID 0000-0002-2985-4099
Sophia Phuong Thao Hoang
Arne Blickle
Mark Bartholomä
Stephan Maus
Connor Hein
Tilman Speicher
Andrea Schaefer-SchulerORCID 0000-0002-2439-5786

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo enhance the effectiveness of radioligand therapy (RLT), new prostate-specific membrane antigen (PSMA) targeting radiopharmaceuticals utilizing alternative radionuclides are under active investigation. One promising alternative to the established 177 Lu is the use of 161 Tb. A key advantage of 161 Tb is its emission of a higher proportion of low-energy conversion and Auger electrons, which may contribute to enhanced therapeutic effectiveness. This study provides a first exploratory evaluation of the efficacy and safety of [ 161 Tb]Tb-PSMA-617 in patients with progression after [ 177 Lu]Lu-PSMA-617, aiming to generate early clinical insights.

methodsThe study included 15 patients with mCRPC, who were enrolled in the "prospective registry to assess outcome and toxicity of targeted radionuclide therapy in patients with mCRPC in clinical routine" (REALITY Study; NCT04833517). All patients had received conventional PSMA RLT using [ 177 Lu]Lu-PSMA-617, which resulted in initial biochemical response (PSA decline ≥50%), followed by a biochemical relapse, prompting the re-initiation of PSMA RLT using [ 161 Tb]Tb-PSMA-617. Patients received a median of 3 (range: 2-7) cycles with mean administered activity of 5.4 ± 1.1 GBq and mean cumulative activity of 19.2 ± 6.4 GBq [ 161 Tb]Tb-PSMA-617. Treatment response was assessed both biochemically by serum PSA levels and through molecular imaging by total lesion PSMA (TLP) on [ 68 Ga]Ga-PSMA-11 PET/CT scans. Adverse events were assessed at baseline and follow-up using the "Common Terminology Criteria for Adverse Events" (Version 5.0).

results[ 161 Tb]Tb-PSMA-617 RLT showed response rates of 66.7% (10/15 patients) based on biochemical assessment and 86.7% (13/15 patients) based on molecular imaging assessment. Beginning with the initiation of [ 161 Tb]Tb-PSMA-617 RLT, the median progression-free survival (PFS) was 6.4 months, and the median overall survival (OS) was 15.5 months. In total, 6 CTCAE grade deteriorations from grade 2 to grade 3 or from grade 3 to grade 4 were observed. No discontinuation of PSMA RLT due to adverse events was reported.

conclusions[ 161 Tb]Tb-PSMA-617 RLT emerges as a promising treatment option, demonstrating encouraging response rates, preliminary clinical outcomes, and a favorable safety profile as second-line RLT in progressing patients who previously benefited from [ 177 Lu]Lu-PSMA-617 RLT.

Indexed as

DipeptidesHeterocyclic CompoundsHeterocyclic Compounds, 1-RingLutetiumProstatic Neoplasms, Castration-ResistantSafetyTerbiumAgedDisease ProgressionHumansLigandsMaleMiddle AgedProstate-Specific AntigenRadioisotopesTreatment OutcomeDipeptidesHeterocyclic CompoundsHeterocyclic Compounds, 1-RingLigandsLutetiumLutetium-177Prostate-Specific AntigenPSMA-617RadioisotopesTerbium161Tb177Lulutetium-177mCRPCprostate cancerPSMAradioligand therapyRLTterbium-161

Identifiers

PMID42080618
PMCPMC13132088

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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.