Therapy Detail
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| Therapy Name | Apalutamide + Leuprolide |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Apalutamide | Erleada | ARN-509|JNJ-56021927 | Hormone - Anti-androgens 54 | Erleada (apalutamide) is a second-generation antiandgrogen, that binds to the androgen receptor (AR) and inhibits downstream signaling, potentially resulting in decreased growth of AR-expressing tumors (PMID: 22266222, PMID: 23337756). Erleada (apalutamide) is FDA approved for use in patients with non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer (FDA.gov). |
| Leuprolide | Lupron | Leuprorelin | Lupron (leuprolide) is an agonist of gonadotropin releasing hormone (GnRH), which results decreased testosterone production in males and decreased estradiol production in females, potentially leading to decreased growth of androgen-positive tumors (NCI Drug Dictionary). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02770391 | Phase II | Apalutamide + Leuprolide | ARN-509 and Leuprolide in Intermediate and High-risk Prostate Cancer | Completed | USA | 0 |
| NCT02811809 | Phase II | Leuprolide Apalutamide + Leuprolide | Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer | Withdrawn | USA | 0 |
| NCT04423211 | Phase III | Apalutamide + Leuprolide Apalutamide + Goserelin Leuprolide Goserelin | Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Using PET/CT Imaging | Recruiting | USA | 0 |
| NCT04585932 | Phase II | Apalutamide + Degarelix Apalutamide + Leuprolide | Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study | Withdrawn | USA | 0 |
| NCT04557059 | Phase III | Apalutamide + Triptorelin Triptorelin Apalutamide + Goserelin Apalutamide + Leuprolide Leuprolide Goserelin | A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Prostate-Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Positive Hormone-Sensitive Prostate Cancer Participants (PRIMORDIUM) | Active, not recruiting | USA | TUR | SWE | SVK | POL | LBN | ITA | HUN | FIN | ESP | DNK | DEU | CZE | BRA | BEL | AUT | AUS | 4 |
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