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

Universität des Saarlandes

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT04833517

RNT-Prostate

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 7 patient groups

Lu177 PSMA RLT

Description:

Lutetium-177 prostate-specific membrane antigen (Lu177 PSMA) radioligand therapy (RLT) according to standard local protocol

Ac225 PSMA RLT

Description:

Actinium-225 prostate-specific membrane antigen (Ac225 PSMA) radioligand therapy (RLT) according to standard local protocol

Tandem Lu177 / Ac225 PSMA RLT

Description:

Combined Lu177 / Ac225 PSMA radioligand therapy according to standard local protocol

Ra223 chloride

Description:

Bone-targeted Radium-223 (Ra223) radionuclide therapy in standard application

Sm153 EDTMP

Description:

Bone-targeted Samarium-153 (Sm153) EDTMP radionuclide therapy in standard application

Y90 microspheres

Description:

Radioembolization with yttrium-90 (Y90) microspheres, standard methodology

Tb161 PSMA RLT

Description:

Terbium-161 prostate-specific membrane antigen (Tb161 PSMA) radioligand therapy (RLT) according to standard local protocol