Registry of Targeted Radionuclide Therapies for Advanced Prostate Cancer
REALITY Study: Analysis of a Prospective REgistry to Assess Outcome and Toxicity of Targeted RadionucLide TherapY in Patients With mCRPC in Clinical Routine.
This study is trying to see how well targeted radionuclide therapies, like PSMA-targeted treatments, work and what side effects they have for people with advanced prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Universität des Saarlandes Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Homburg, Saarland) |
| Trial ID | NCT04833517 on ClinicalTrials.gov |
What this trial studies
This prospective registry aims to evaluate the outcomes and toxicity of targeted radionuclide therapies in patients with advanced prostate cancer, particularly focusing on PSMA-targeted radioligand therapy. The study will collect long-term data on the effectiveness and risks associated with various radionuclide treatments, including Radium-223 and liver-directed radioembolization. By assessing real-life clinical applications and patient outcomes, the study seeks to provide valuable insights into the benefits and risks of these therapies in a palliative setting.
Who should consider this trial
Good fit: Ideal candidates include patients with metastatic castration-resistant prostate cancer who have sufficient PSMA expression and meet specific health criteria.
Not a fit: Patients who are unable or unwilling to provide informed consent or do not meet the health criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical data to improve treatment strategies and patient outcomes for those with advanced prostate cancer.
How similar studies have performed: While there is limited data on the specific outcomes of this registry approach, similar studies on radionuclide therapies have shown promising results in improving patient management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Homburg, Saarland
- Dept. of Nuclear Medicine, Saarland University — Homburg, Saarland, Germany (Recruiting)
Study contacts
- Principal investigator: Samer Ezziddin, MSc, MD, PhD — Universität des Saarlandes
- Study coordinator: Samer Ezziddin, MSc, MD, PhD
- Email: PSMA@uks.eu
- Phone: +49 6841 16 22201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.