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

Recruiting

• Conditions: Advanced Prostate Carcinoma; Prostate Cancer Metastatic; Castration Resistant Prostatic Cancer

• Registration Number: NCT04833517
• Lead Sponsor: Universität des Saarlandes

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.

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations
|
Related News

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-04-04
• Study First Posted: 2021-04-06
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 500

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

Read More

Exclusion Criteria

• Inability or unwillingness to provide informed consent

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OS	up to 10 years	Overall survival. From date of start of radionuclide therapy until the date of death from any cause assessed
Toxicity (adverse events)	up to 10 years	All toxicity occurring after start of radionuclide treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.03).
Toxicity-related discontinuation of radionuclide treatment	up to 10 years	Rate of toxicity-related discontinuation of radionuclide therapy
PSA response	up to 10 years	Best PSA response and PSA response after 3 months from start of radionuclide therapy
PSA-PFS	up to 10 years	PSA-based progression-free survival (PFS) according to PCWG3 criteria. From date of start of radionuclide therapy until documented and confirmed PSA-progression

Secondary Outcome Measures

Name	Time	Method
Quality-of-life in patients receiving radionuclide therapy	up to 10 years	Quality-of-life assessed from start of radionuclide treatment by EORTC QLQ-C30 questionaires
Pain control achieved by radionuclide therapy	up to 10 years	Based on VAS-BPI patient questionaires from start of radionuclide treatment
Absorbed doses achieved by radionuclide therapy	up to 10 years	Absorbed doses in Gy/GBq based on intra- / posttherapeutic dosimetry when available
Conventional imaging response	up to10 years	Response to radionuclide therapy based on conventional imaging according to RECIST 1.1
Molecular imaging response	up to 10 years	Response to radionuclide therapy based on molecular imaging

Trial Locations

Locations (1)

Dept. of Nuclear Medicine, Saarland University; 🇩🇪 Homburg, Saarland, Germany