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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04833517
Other study ID # RNT-Prostate
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2025

Study information

Verified date December 2022
Source Universität des Saarlandes
Contact Samer Ezziddin, MSc, MD, PhD
Phone +49 6841 16 22201
Email PSMA@uks.eu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

Targeted radionuclide therapy is comprised of different modalities that may be applied in advanced prostate cancer, either targeting bone metastases (mainly using Radium-223), any site of metastases with PSMA-expression (ß- / alpha-emitter labelled radioligands) or loco-regionally applying internal radiation (Yttrium-90 microspheres) to metastatic liver disease. While in Germany, each form of treatment is used in clinical routine, data is sparse regarding the real benefits and risks of respective modalities, also when used in a sequential order. As an example, patients receiving Ra223 treatment may later undergo PSMA targeted radioligand therapy, with little data available on dependent response relationships or cumulative risks. Prospective assessment of outcomes and toxicities in a radionuclide therapy registry is apparently superior over retrospective analyses of selected patient populations. The goal of the REALITY study is to gain a better understanding of the real-life clinical application of radionuclide therapies, with a focus on PSMA-targeted radioligand therapy in a high-volume treatment centre, and the impact of each treatment for patient outcome. Based on primary and secondary outcome measures the potential prediction of treatment benefit by baseline patient and tumor characteristics, and early changes of biomarkers will be of interest.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Dept. of Nuclear Medicine, Saarland University Homburg Saarland

Sponsors (1)

Lead Sponsor Collaborator
Universität des Saarlandes

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary PSA response Best PSA response and PSA response after 3 months from start of radionuclide therapy up to 10 years
Primary 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
Primary OS Overall survival. From date of start of radionuclide therapy until the date of death from any cause assessed up to 10 years
Primary 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
Primary Toxicity-related discontinuation of radionuclide treatment Rate of toxicity-related discontinuation of radionuclide therapy up to 10 years
Secondary Conventional imaging response Response to radionuclide therapy based on conventional imaging according to RECIST 1.1 up to10 years
Secondary Molecular imaging response Response to radionuclide therapy based on molecular imaging up to 10 years
Secondary Quality-of-life in patients receiving radionuclide therapy Quality-of-life assessed from start of radionuclide treatment by EORTC QLQ-C30 questionaires up to 10 years
Secondary Pain control achieved by radionuclide therapy Based on VAS-BPI patient questionaires from start of radionuclide treatment up to 10 years
Secondary Absorbed doses achieved by radionuclide therapy Absorbed doses in Gy/GBq based on intra- / posttherapeutic dosimetry when available up to 10 years
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