Clinical trial · Interventional
Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
Phase 2 Study of Enzalutamide and GnRH Agonist Before, During and After Radiation Therapy in Treatment of Patients With High-risk Localized Prostate Cancer
NCT02064582CI-TRIAL-00047614completedPhase 2Results postedClinicalTrials.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)
The study is being done to find out whether combining two FDA approved drugs along with radiation therapy for the treatment of high risk localized prostate cancer is safe and well tolerated.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Leuprolide acetate | Drug | Leuprolide | ALIAS |
| radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Enzalutamide, Leuprolide, radiation
- description
- Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care
- interventionNames
- Drug: Enzalutamide
- Drug: Leuprolide acetate
- Radiation: radiation
Primary outcomes (1)
- measure
- Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation
- timeFrame
- 12 months following initiation of treatment with enzalutamide plus GnRH agonist
- description
- Assessment will number of participants who experience adverse events greater than or equal to Grade 3, as defined by NCI Common terminology criteria for adverse events(CTCAE) v4.0
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven adenocarcinoma of the prostate within 6 months of screening * Eastern Cooperative Oncology Group(ECOG) score 0-2 * adequate organ and and blood marrow function * must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer * patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment * men who are sexually active with female partners of child-bearing potential mush agree to use adequate contraception Exclusion Criteria: * prior treatment with agents known to have endocrine effects on prostate cancer * treatment with corticosteroids within 4 weeks of enrollment * treatment with androgens within 6 months of enrollment * may not be receiving any other investigational agents * Prostate specific antigen greater than 160ng/dL * history of malignancy( other than non-melanoma skin cancer) within 5 years * uncontrolled intercurrent illness * cardiovascular event within 6 months of enrollment * seizure or seizure disorder history * contraindications to MRI- pacemakers, clips, etc
References
Publications (1)
- BACKGROUNDLi J, Alyamani M, Zhang A, Chang KH, Berk M, Li Z, Zhu Z, Petro M, Magi-Galluzzi C, Taplin ME, Garcia JA, Courtney K, Klein EA, Sharifi N. Aberrant corticosteroid metabolism in tumor cells enables GR takeover in enzalutamide resistant prostate cancer. Elife. 2017 Feb 13;6:e20183. doi: 10.7554/eLife.20183. PMID 28191869