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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04833517

Studienbeginn:
Januar 2016

Letztes Update:
08.12.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Universität des Saarlandes

Collaborator:
-

Studienleiter

Samer Ezziddin, MSc, MD, PhD
Principal Investigator
Universität des Saarlandes

Kontakt

Studienlocations
(1 von 1)

Dept. of Nuclear Medicine, Saarland University
66421 Homburg
(Saarland)
GermanyRekrutierend» Google-Maps

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. PSA response (Time Frame - up to 10 years):
Best PSA response and PSA response after 3 months from start of radionuclide therapy

2. 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

3. 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

4. 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).

5. Toxicity-related discontinuation of radionuclide treatment (Time Frame - up to 10 years):
Rate of toxicity-related discontinuation of radionuclide therapy

Secondary outcome:

1. Conventional imaging response (Time Frame - up to10 years):
Response to radionuclide therapy based on conventional imaging according to RECIST 1.1

2. Molecular imaging response (Time Frame - up to 10 years):
Response to radionuclide therapy based on molecular imaging

3. Quality-of-life in patients receiving radionuclide therapy (Time Frame - up to 10 years):
Quality-of-life assessed from start of radionuclide treatment by EORTC QLQ-C30 questionaires

4. Pain control achieved by radionuclide therapy (Time Frame - up to 10 years):
Based on VAS-BPI patient questionaires from start of radionuclide treatment

5. Absorbed doses achieved by radionuclide therapy (Time Frame - up to 10 years):
Absorbed doses in Gy/GBq based on intra- / posttherapeutic dosimetry when available

Studien-Arme

  • 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

Quelle: ClinicalTrials.gov


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