Impact of 177Lu-PSMA therapy on kidney function in prostate cancer patients
177Lu-PSMA-KiRi-trial
This study is testing how a new prostate cancer treatment affects kidney function in men with advanced prostate cancer over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 1 site (Munich) |
| Trial ID | NCT06720532 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how 177Lutetium-Prostate Specific Membrane Antigen (PSMA) Radioligand Therapy affects kidney function in patients with metastatic castration-resistant prostate cancer (mCRPC). It will monitor kidney function using routine markers like creatinine and cystatin C before, during, and after therapy, with follow-ups extending up to 5 years. The study will also collect additional biomarkers and patient-reported outcomes to identify risk factors for chronic kidney disease and correlate them with clinical data. A total of 100 patients will be included to ensure robust data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with metastatic castration-resistant prostate cancer who are starting their first cycle of 177Lu-PSMA therapy.
Not a fit: Patients who are not starting 177Lu-PSMA therapy or are under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify kidney function decline in prostate cancer patients undergoing treatment, leading to better management of kidney health.
How similar studies have performed: While there have been studies on kidney function in cancer therapies, this specific approach focusing on 177Lu-PSMA therapy and its renal impact is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle). Exclusion Criteria: * Missing or incomplete informed consent. * age below 18 years
Where this trial is running
Munich
- Klinikum rechts der Isar, München, Bavaria 81675 — Munich, Germany (Recruiting)
Study contacts
- Study coordinator: Hannah Schäfer/ Christoph Schmaderer
- Email: hannah.schaefer@mri.tum.de
- Phone: +49 - 89 4140 8383
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.