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.

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Samer Ezziddin, MSc, MD, PhD; Phone Number: +49 6841 16 22201; Email: PSMA@uks.eu
• Study Contact Backup: Name: Katja Threm; Phone Number: +49 6841 16 24667; Email: nuklearmedizin@uks.eu

Study Locations

• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Recruiting
      • Dept. of Nuclear Medicine, Saarland University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conventional imaging response	Response to radionuclide therapy based on conventional imaging according to RECIST 1.1	up to10 years
Molecular imaging response	Response to radionuclide therapy based on molecular imaging	up to 10 years
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
Pain control achieved by radionuclide therapy	Based on VAS-BPI patient questionaires from start of radionuclide treatment	up to 10 years
Absorbed doses achieved by radionuclide therapy	Absorbed doses in Gy/GBq based on intra- / posttherapeutic dosimetry when available	up to 10 years

Collaborators and Investigators

• Sponsor: Universität des Saarlandes
• Investigators: Principal Investigator: Samer Ezziddin, MSc, MD, PhD, Universität des Saarlandes

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 4, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: mCRPC; PSMA; Radioligand Therapy; SIRT; Radioembolization; PSMA-targeted Therapy; Radionuclide Therapy; Ra-223; Bone-targeted Radionuclide Therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant
• Other Study ID Numbers: RNT-Prostate

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No