Clinical trial · Interventional
Identification of Predictive Biomarkers
Identification of Predictive Biomarkers for Successful Salvage Surgeries on PSMA-PET-positive Limited Metastatic Prostate Cancer Relapses
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Molecular nuclear imaging in prostate cancer has made significant progress in the last few years. The introduction of tracers that target the prostate-specific membrane antigen (PSMA) has profoundly influenced imaging diagnostics in prostate cancer. In case of relapse after curative treatment (especially after radical prostatectomy), PSMA positron emission tomography (PET) has the ability to detect lesions already at very low prostate-specific antigen (PSA) levels. The improved detection of relapses increases the interest of individualized targeted therapies in patients with prostate cancer recurrence. Thus, this development led to the acceptance of PSMA PET for diagnostics in prostate cancer patients with biochemical relapses in national and international guidelines.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Biomarker
- description
- This single-arm study is a Phase I study to exploratively identify potential biomarkers in patients with early prostate cancer relapse and limited metastases in PSMA-PET, who need further assistance in treatment decisions (for or against local treatment options).
- interventionNames
- Other: Blood sample
Primary outcomes (1)
- measure
- Rate of complete biochemical response (cBR: PSA <0,2ng/ml)
- timeFrame
- 6 months
- description
- PSA Level after salvage lymphadenectomy without adjuvant prostate cancer-specific treatment
Secondary outcomes (2)
- measure
- Prostate cancer-specific treatment-free survival after salvage surgery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients in good general health and an expected life expectancy of \> 10 years * Diagnosis of prostate cancer relapse * Evidence of positive lymph nodes or soft tissue metastases as seen in PSMA PET Exclusion Criteria: * Contraindication for a surgical procedure * Clinical suspicion of systemic disease as determined by PSMA PET * PSMA PET examination older than 4 months at time of surgery
References
Publications (1)
- DERIVEDRiethdorf S, Knipper S, Falkenbach F, Coith C, Tilki D, Graefen M, Werner S, Pantel K, Maurer T. Identification of Biomarkers Predictive of Successful Salvage Surgery in Prostate-specific Membrane Antigen Positron Emission Tomography-positive Oligorecurrent Prostate Cancer: Results from the BioPoP Trial. Eur Urol Focus. 2026 Feb 27:S2405-4569(25)00292-5. doi: 10.1016/j.euf.2025.10.006. Online ahead of print. PMID 41763960