Clinical trial · Observational
Liquid Biopsy-based Detection of Resistance to Targeted Therapy in Prostate Cancer Patients
NCT03601143CI-TRIAL-00061580PEARLunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study will prospectively compare liquid-biopsy based methods for prediction of resistance under androgen-receptor signaling inhibitors. The main goal is to determine the optimal method to determine androgen-receptor variant 7 (AR-V7) status. In addition, the investigators will explore novel other, AR-V7 independent mechanisms of resistance and their predictive value for proper treatment. These are based on further AR splice variants, and on neuroendocrine differentiation of prostate cancer cells.
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 |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples prior to a new line of AR-targeted therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prostate-specific antigen (PSA) decline >=50%
- timeFrame
- 24 months
- description
- The optimal liquid biopsy-based test method to predict PSA response under AR-targeted therapy will be determined.
Secondary outcomes (2)
- measure
- Clinical progression-free survival
- timeFrame
- 24 months
- description
- The optimal liquid biopsy-based test method to predict clinical progression-free survival under AR-targeted therapy will be determined.
- measure
- Overall survival
- timeFrame
- 36 months
- description
- The optimal liquid biopsy-based test method to predict overall survival under AR-targeted therapy will be determined.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma * Castrate serum testosterone \<50ng/ml or \<1.7nmol/l under continued androgen-deprivation therapy or surgical castration * Progressive disease at study entry in accordance with Prostate Cancer Working Group 3 criteria (PCWG3): * Biochemical progression: Three consecutive rises in PSA at least one week apart resulting in two 50% increases over the nadir, and a PSA \>1.0 ng/ml as minimal starting value, or * Radiologic progression: either two or more new bone lesions on bone scan or a new soft tissue lesion using RECIST (Response evaluation criteria in solid tumors). * Metastatic disease confirmed on computed tomography (CT) or bone scan * Planned treatment with ARSi (androgen-receptor signaling receptors) * Written informed consent of the patient Exclusion Criteria: * Persons who are in a dependency or employment relationship with the investigator or sponsor * Planned additional concurrent anticancer therapy
References
Publications (1)
- BACKGROUNDSeitz AK, Thoene S, Bietenbeck A, Nawroth R, Tauber R, Thalgott M, Schmid S, Secci R, Retz M, Gschwend JE, Ruland J, Winter C, Heck MM. AR-V7 in Peripheral Whole Blood of Patients with Castration-resistant Prostate Cancer: Association with Treatment-specific Outcome Under Abiraterone and Enzalutamide. Eur Urol. 2017 Nov;72(5):828-834. doi: 10.1016/j.eururo.2017.07.024. Epub 2017 Aug 14. PMID 28818355