Prospective REgistry of Targeted RadionucLide TherapY in Patients With mCRPC (REALITY Study)

NCT04833517 | Unknown

• 1 other identifier: RNT-Prostate
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer Metastatic; Castration Resistant Prostatic Cancer; Advanced Prostate Carcinoma

Keywords

mCRPC; Radioligand Therapy; PSMA; PSMA-targeted Therapy; Radionuclide Therapy; Ra-223; Bone-targeted Radionuclide Therapy; Radioembolization; SIRT

Outcome Measures

Primary Outcomes (5)

• PSA response

  Best PSA response and PSA response after 3 months from start of radionuclide therapy

  up to 10 years

• PSA-PFS

  PSA-based progression-free survival (PFS) according to PCWG3 criteria. From date of start of radionuclide therapy until documented and confirmed PSA-progression

  up to 10 years

• OS

  Overall survival. From date of start of radionuclide therapy until the date of death from any cause assessed

  up to 10 years

• Toxicity (adverse events)

  All toxicity occurring after start of radionuclide treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.03).

  up to 10 years

• Toxicity-related discontinuation of radionuclide treatment

  Rate of toxicity-related discontinuation of radionuclide therapy

  up to 10 years

Secondary Outcomes (5)

• Conventional imaging response

  up to10 years

• Molecular imaging response

  up to 10 years

• Quality-of-life in patients receiving radionuclide therapy

  up to 10 years

• Pain control achieved by radionuclide therapy

  up to 10 years

• Absorbed doses achieved by radionuclide therapy

  up to 10 years

Study Arms (7)

Lu177 PSMA RLT

Lutetium-177 prostate-specific membrane antigen (Lu177 PSMA) radioligand therapy (RLT) according to standard local protocol

Ac225 PSMA RLT

Actinium-225 prostate-specific membrane antigen (Ac225 PSMA) radioligand therapy (RLT) according to standard local protocol

Tandem Lu177 / Ac225 PSMA RLT

Combined Lu177 / Ac225 PSMA radioligand therapy according to standard local protocol

Ra223 chloride

Bone-targeted Radium-223 (Ra223) radionuclide therapy in standard application

Sm153 EDTMP

Bone-targeted Samarium-153 (Sm153) EDTMP radionuclide therapy in standard application

Y90 microspheres

Radioembolization with yttrium-90 (Y90) microspheres, standard methodology

Tb161 PSMA RLT

Terbium-161 prostate-specific membrane antigen (Tb161 PSMA) radioligand therapy (RLT) according to standard local protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced castration-resistant prostate cancer, who receive radionuclide treatment including PSMA-targeted radioligand therapy, Radium-223 or other bone-targeted radionuclide therapy and liver-directed radioembolization.

You may qualify if:

• 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

You may not qualify if:

• Inability or unwillingness to provide informed consent

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

Dept. of Nuclear Medicine, Saarland University

Homburg, Saarland, 66421, Germany

RECRUITING

Related Publications (4)

• Bastian 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 DERIVED

• Rosar 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 DERIVED

• Rosar F, Burgard C, Rohloff LV, Blickle A, Bartholoma M, Maus S, Petto S, Schaefer-Schuler A, Ezziddin S. 225 Ac-PSMA-617 Augmentation in High-Risk mCRPC Undergoing 177 Lu-PSMA-617 Radioligand Therapy : Pilot Experience From a Prospective Registry. Clin Nucl Med. 2024 Jul 1;49(7):621-629. doi: 10.1097/RLU.0000000000005253. Epub 2024 May 21.

  PMID: 38769643 DERIVED

• Burgard C, Hein C, Blickle A, Bartholoma M, Maus S, Petto S, Schaefer-Schuler A, Ezziddin S, Rosar F. Change in total lesion PSMA (TLP) during [177Lu]Lu-PSMA-617 radioligand therapy predicts overall survival in patients with mCRPC: monocentric evaluation of a prospective registry. Eur J Nucl Med Mol Imaging. 2024 Feb;51(3):885-895. doi: 10.1007/s00259-023-06476-x. Epub 2023 Oct 27.

  PMID: 37889298 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Samer Ezziddin, MSc, MD, PhD

  Universität des Saarlandes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samer Ezziddin, MSc, MD, PhD

CONTACT

+49 6841 16 22201; PSMA@uks.eu

Katja Threm

CONTACT

+49 6841 16 24667; nuklearmedizin@uks.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Dept. of Nuclear Medicine

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 6, 2021
• Study Start: January 1, 2016
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

DE (1)