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

Sponsor

Universität des Saarlandes (Other)

Overall Status

Recruiting

CT.gov ID

NCT04833517

Collaborator

(none)

500

Enrollment

Location

120

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Metastatic Castration Resistant Prostatic Cancer Advanced Prostate Carcinoma

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 type of metastases with PSMA-expression (Lutetium-177 and Actinium-225 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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 microshperes Radioembolization with yttrium-90 (Y90) microspheres, standard methodology

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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