Clinical trial · Observational
Prospective REgistry of Targeted RadionucLide TherapY in Patients With mCRPC (REALITY Study)
REALITY Study: Analysis of a Prospective REgistry to Assess Outcome and Toxicity of Targeted RadionucLide TherapY in Patients With mCRPC in Clinical Routine.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective registry aims to assess outcome and toxicity of targeted radionuclide therapies in patients with advanced prostate cancer in clinical routine. While the major investigated treatment modality is prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, also other radionuclide therapies such as Ra223 and liver-directed radioembolization are included. The investigators believe that prospectively assessed long-term outcome data on implementation of radionuclide therapy, especially in the palliative setting of advanced mCRPC, help to better define the real benefits and risks of the respective treatment modalities for patients regarding survival and quality-of-life.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Castration Resistant Prostatic Cancer | — | UNRESOLVED | — |
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (7)
- label
- Lu177 PSMA RLT
- description
- Lutetium-177 prostate-specific membrane antigen (Lu177 PSMA) radioligand therapy (RLT) according to standard local protocol
- label
- Ac225 PSMA RLT
- description
- Actinium-225 prostate-specific membrane antigen (Ac225 PSMA) radioligand therapy (RLT) according to standard local protocol
- label
- Tandem Lu177 / Ac225 PSMA RLT
- description
- Combined Lu177 / Ac225 PSMA radioligand therapy according to standard local protocol
- label
- Ra223 chloride
- description
- Bone-targeted Radium-223 (Ra223) radionuclide therapy in standard application
- label
- Sm153 EDTMP
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent form (Registry Study Inclusion Form) Inclusion Criteria for PSMA RLT: * sufficient tumoral PSMA expression defined as tracer uptake markedly higher than (physiologic) uptake in healthy liver tissue. * sufficient bone marrow reserve: leukocytes ≥ 2 G/L, platelets \> 75 × 109/L * sufficient overall patient condition: Eastern Oncology Cooperative Group (ECOG) performance status ≤ 3 Exclusion Criteria: * Inability or unwillingness to provide informed consent
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Andrea Schaefer-Schuler, Arne Blickle, Sebastian Ganz et al. · Eur J Nucl Med Mol Imaging · Sep 8, 2026 · PMID 42709069 pubmed
- DERIVEDBastian MB, Speicher T, Blickle A, Burgard C, Bastian JLD, Bartholoma M, Schaefer-Schuler A, Maus S, Ezziddin S, Rosar F. Tolerability of PSMA radioligand therapy in metastatic prostate cancer patients with baseline mild to moderate leukopenia. EJNMMI Res. 2025 Jul 6;15(1):82. doi: 10.1186/s13550-025-01280-0. PMID 40619537
- DERIVEDRosar F, Schuler J, Burgard C, Blickle A, Bartholoma M, Maus S, Petto S, Khreish F, Schaefer A, Ezziddin S. Efficacy and safety of rechallenge [177Lu]Lu-PSMA-617 RLT after initial partial remission in patients with mCRPC: evaluation of a prospective registry (REALITY study). Eur J Nucl Med Mol Imaging. 2024 Nov;51(13):4151-4162. doi: 10.1007/s00259-024-06825-4. Epub 2024 Jul 15. PMID 39008067