Clinical trial NCT04833517: Prospective REgistry of Targeted RadionucLide TherapY in Patients With mCRPC (REALITY Study)
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer Metastatic
Castration Resistant Prostatic Cancer
Advanced Prostate Carcinoma
Keywords: mCRPC
Radioligand Therapy
PSMA
PSMA-targeted Therapy
Radionuclide Therapy
Ra-223
Bone-targeted Radionuclide Therapy
Radioembolization
SIRT
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: PSA response
timeFrame: up to 10 years
measure: PSA-PFS
timeFrame: up to 10 years
measure: OS
timeFrame: up to 10 years
measure: Toxicity (adverse events)
timeFrame: up to 10 years
measure: Toxicity-related discontinuation of radionuclide treatment
timeFrame: up to 10 years
Secondary outcomes:
measure: Conventional imaging response
timeFrame: up to10 years
measure: Molecular imaging response
timeFrame: up to 10 years
measure: Quality-of-life in patients receiving radionuclide therapy
timeFrame: up to 10 years
measure: Pain control achieved by radionuclide therapy
timeFrame: up to 10 years
measure: Absorbed doses achieved by radionuclide therapy
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Dept. of Nuclear Medicine, Saarland University
state: Saarland
Study officials:
affiliation: Universität des Saarlandes
name: Samer Ezziddin, MSc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: