REALITY Study: Analysis of a Prospective REgistry to Assess Outcome and Toxicity of Targeted RadionucLide TherapY in Patients With mCRPC in Clinical Routine.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer Metastatic
- Sponsor
- Universität des Saarlandes
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- OS
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Samer Ezziddin, MD
Director, Dept. of Nuclear Medicine
Universität des Saarlandes
Eligibility Criteria
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
Outcomes
Primary Outcomes
OS
Time Frame: 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)
Time Frame: 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
Time Frame: up to 10 years
Rate of toxicity-related discontinuation of radionuclide therapy
PSA response
Time Frame: up to 10 years
Best PSA response and PSA response after 3 months from start of radionuclide therapy
PSA-PFS
Time Frame: 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 Outcomes
- 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)
- Conventional imaging response(up to10 years)
- Molecular imaging response(up to 10 years)