Clinical trial · Interventional
Dynamics of Androgen Receptor Genomics and Transcriptomics After Neoadjuvant Androgen Ablation
- 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)
Rationale: Understanding the mechanisms of enzalutamide as an androgen receptor inhibitor in early prostate cancer could lead to improved patient selection for treatment. Objective: To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression. Intervention : Men with localized prostate cancer will undergo an additional set of targeted tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The prostatectomy specimen will be additionally sampled, ex vivo.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Androgen Receptor Abnormal | — | UNRESOLVED | — |
| DNA | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostatectomy after enzalutamide
- description
- This is a single-arm study. Patients will have biopsies, after which they will receive enzalutamide for 3 months. After 3 months they will have a prostatectomy.
- interventionNames
- Drug: Enzalutamide
Primary outcomes (2)
- measure
- Effects of enzalutamide on tumor downstaging
- timeFrame
- From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
- description
- To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression.
- measure
- Genetic and transcriptional changes caused by enzalutamide
- timeFrame
- From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men over 18 years of age. 2. clinically non-metastasized prostate cancer, tumor that can be imaged (TRUS or MRI) in order to allow for accurate preoperative biopsies. 3. Gleason score 7-10 4. written informed consent 5. WHO performance 0-1 Exclusion Criteria: 1. A history of seizures. 2. Clinically nodal metastases. 3. Prostatitis or urinary tract infection. 4. Androgen ablative therapy within 6 weeks of inclusion (including 5 alpha-reductase inhibitors). 5. Tumor of the prostate that can not be visualized by TRUS or MRI.
References
Publications (1)
- DERIVEDZhang M, Moreno-Rodriguez T, Quigley DA. Why ARNT Prostate Tumors Responding to Enzalutamide? Cancer Discov. 2022 Sep 2;12(9):2017-2019. doi: 10.1158/2159-8290.CD-22-0702. PMID 36052502