Advanced Prostate Carcinoma, Castration Resistant Prostatic Cancer, Prostate Cancer Metastatic
Conditions
Keywords
mCRPC, Radioligand Therapy, PSMA, PSMA-targeted Therapy, Radionuclide Therapy, Ra-223, Bone-targeted Radionuclide Therapy, Radioembolization, SIRT
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.
Interventions
None listed
Sponsors
Universität des Saarlandes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity-related discontinuation of radionuclide treatment | up to 10 years | Rate of toxicity-related discontinuation of radionuclide therapy |
| PSA response | up to 10 years | Best PSA response and PSA response after 3 months from start of radionuclide therapy |
| PSA-PFS | 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 |
| OS | 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conventional imaging response | up to10 years | Response to radionuclide therapy based on conventional imaging according to RECIST 1.1 |
| Molecular imaging response | up to 10 years | Response to radionuclide therapy based on molecular imaging |
| Quality-of-life in patients receiving radionuclide therapy | up to 10 years | Quality-of-life assessed from start of radionuclide treatment by EORTC QLQ-C30 questionaires |
| Pain control achieved by radionuclide therapy | up to 10 years | Based on VAS-BPI patient questionaires from start of radionuclide treatment |
| Absorbed doses achieved by radionuclide therapy | up to 10 years | Absorbed doses in Gy/GBq based on intra- / posttherapeutic dosimetry when available |
Countries
Germany
Contacts
Primary ContactSamer Ezziddin, MSc, MD, PhD
Backup ContactKatja Threm
Outcome results
None listed