Prostate Cancer Metastatic Clinical Trial
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.
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Dept. of Nuclear Medicine, Saarland University | Homburg | Saarland |
Lead Sponsor | Collaborator |
---|---|
Universität des Saarlandes |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PSA response | Best PSA response and PSA response after 3 months from start of radionuclide therapy | up to 10 years | |
Primary | PSA-PFS | PSA-based progression-free survival (PFS) according to PCWG3 criteria. From date of start of radionuclide therapy until documented and confirmed PSA-progression | up to 10 years | |
Primary | OS | Overall survival. From date of start of radionuclide therapy until the date of death from any cause assessed | up to 10 years | |
Primary | Toxicity (adverse events) | All toxicity occurring after start of radionuclide treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.03). | up to 10 years | |
Primary | Toxicity-related discontinuation of radionuclide treatment | Rate of toxicity-related discontinuation of radionuclide therapy | up to 10 years | |
Secondary | Conventional imaging response | Response to radionuclide therapy based on conventional imaging according to RECIST 1.1 | up to10 years | |
Secondary | Molecular imaging response | Response to radionuclide therapy based on molecular imaging | up to 10 years | |
Secondary | Quality-of-life in patients receiving radionuclide therapy | Quality-of-life assessed from start of radionuclide treatment by EORTC QLQ-C30 questionaires | up to 10 years | |
Secondary | Pain control achieved by radionuclide therapy | Based on VAS-BPI patient questionaires from start of radionuclide treatment | up to 10 years | |
Secondary | Absorbed doses achieved by radionuclide therapy | Absorbed doses in Gy/GBq based on intra- / posttherapeutic dosimetry when available | up to 10 years |
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