Clinical trial · Observational
Micro RNAs to Predict Response to Androgen Deprivation Therapy
Utility of Exosomal microRNAs to Predict Response to Androgen Deprivation Therapy in Prostate Cancer Patients
NCT02366494CI-TRIAL-00082976completedClinicalTrials.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)
Identify exosomal micro RNA that predict responses to ADT
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 | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone | Drug | Abiraterone | ALIAS |
| Apalutamide | Drug | Apalutamide | ALIAS |
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Goserelin | Drug | Goserelin | ALIAS |
| Leuprolide | Drug | Leuprolide | ALIAS |
| Triptorelin | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Androgen blockade
- description
- Androgen DeprivationTherapy or Complete Androgen Blockade
- interventionNames
- Drug: Bicalutamide
- Drug: Leuprolide
- Drug: Goserelin
- Drug: Triptorelin
- label
- Hormonal Therapy and Chemotherapy
- description
- Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)
- interventionNames
- Drug: Bicalutamide
- Drug: Leuprolide
- Drug: Goserelin
- Drug: Triptorelin
- Drug: Docetaxel
- Drug: Abiraterone
- Drug: Apalutamide
- Drug: Enzalutamide
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate cancer. * Testosterone level \>30ng/ml and at least 6 months since last dose of hormonal therapy. * History/physical examination including a detailed description of the stage of prostate cancer within 8 weeks prior to registration. * CT scan of abdomen and pelvis with IV contrast and bone scan should be performed within 8 weeks prior to registration. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. * Age ≥ 18. * Patients must provide study-specific informed consent prior to study entry for this project and mandatory blood specimen for banking for future studies (future studies may include genetic testing). Exclusion Criteria: * Received hormonal therapy less than 6 months prior to registration. * History of active secondary malignancy. * Decline hormone therapy for prostate cancer. * Current or previous treatment with 5-alpha reductase inhibitors within 6 months prior to enrollment.
References
Publications (3)
- BACKGROUNDTaplin ME, Xie W, Bubley GJ, Ernstoff MS, Walsh W, Morganstern DE, Regan MM. Docetaxel, estramustine, and 15-month androgen deprivation for men with prostate-specific antigen progression after definitive local therapy for prostate cancer. J Clin Oncol. 2006 Dec 1;24(34):5408-13. doi: 10.1200/JCO.2006.06.6589. PMID 17135641
- RESULTScher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487. PMID 18309951
- RESULTHuggins C, Hodges CV. Studies on prostatic cancer. I. The effect of castration, of estrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate. CA Cancer J Clin. 1972 Jul-Aug;22(4):232-40. doi: 10.3322/canjclin.22.4.232. No abstract available. PMID 4625049