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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004203-41 | EudraCT Number | ||
| 56021927PCR3010 | Other Identifier | Aragon Pharmaceuticals, Inc. |
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The purpose of this study is to collect additional safety data until apalutamide is commercially available for participants with non-metastatic castrate-resistant prostate cancer (NM-CRPC).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apalutamide | Drug | Participants will receive apalutamide 240 mg orally once daily. |
| |
| ADT (Standard of Care) | Drug | Participants who did not undergo surgical castration, should receive and remain on a stable regimen of ADT according to local standard of care. |
Inclusion Criteria:
Participants with confirmed prostate cancer, with evidence of castration resistance, with a rising prostate-specific antigen (PSA) while on androgen deprivation therapy (ADT), and for whom the treating physician believes additional therapy is indicated in the non-metastatic castrate-resistant prostate cancer (NM-CRPC) setting
a) Willingness to continue gonadotropin releasing hormone analog (GnRHa) throughout study if the participant is medically castrated
Must sign an informed consent form (ICF) (or the participant's legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
To avoid risk of drug exposure through the ejaculate (even participants with vasectomies), participants must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug
Willingness and ability to comply with prohibitions and restrictions specified in this protocol, scheduled visits, treatment plans, laboratory, and other study procedures, including ability to swallow study drug tablets
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aragon Pharmaceuticals, Inc. Clinical Trial | Aragon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ynova Pesquisa Clinica | Florianópolis | 88020-210 | Brazil | |||
| Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) |
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| Rio de Janeiro |
| 22775 001 |
| Brazil |
| Ensino e Terapia de Inovacao Clinica AMO Etica | Salvador | 41950 640 | Brazil |
| Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo | São Paulo | 01246 000 | Brazil |
| Fundacao Antonio Prudente A C Camargo Cancer Center | São Paulo | 01509 900 | Brazil |
| Núcleo de Pesquisa São Camilo | São Paulo | 04014-002 | Brazil |
| Hospital Pablo Tobon Uribe | Medellín | 050034 | Colombia |
| Instituto Nacional de Cancerologia | México | 14080 | Mexico |
| i Can Oncology Center | Monterrey | 64710 | Mexico |
| Oncologia Integral Satelite | Naucalpan | 53100 | Mexico |
| Centro Oncologico Estatal ISSEMYM | Toluca | 50180 | Mexico |
| Farmaco Oncología especializada S.A. de C.V | Zapopan | 45050 | Mexico |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C572045 | apalutamide |
| D000726 | Androgen Antagonists |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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