Advanced ChemoHormonal Therapy for Treatment Naïve Metastatic Prostate Cancer: Apalutamide and Abiraterone Acetate with Prednisone and Androgen Deprivation Therapy after Treatment with Docetaxel and Androgen Deprivation Therapy
To learn more about the combination of testosterone lowering therapy and chemotherapy followed by a combination of hormonal therapies, apalutamide and abiraterone with prednisone, that may be helpful in treating metastatic prostate cancer. We are hoping to find out more about the efficacy, safety and tolerability of the combination of apalutamide and abiraterone with prednisone following testosterone lowering therapy and chemotherapy.
Newly diagnosed metastatic prostate cancer.
-PSA > 5 ng/mL and high volume metastatic disease
-ADT naive or on ADT <4 months for metastatic disease at the time of chemotherapy initiation without evidence of disease progression
-No prior apalutamide, enzalutamide, abiraterone, ODM-201or other 2nd generation androgen receptor antagonist therapy
-No history of seizures or current treatment with medications that lower the seizure threshold
-Docetaxel therapy for metastatic hormone sensitive prostate cancer completed no more than 12 weeks from the planned initiation of treatment with apalutamide and abiraterone
18 - 110
Healthy Volunteers Needed
Duration of Participation
Duration of participation will vary depending on how your cancer responds. Active treatment with apalutamide and abiraterone with prednisone will continue until your cancer stops responding (approximately 6 months to 3 years). After you are done receiving treatment with apalutamide and abiraterone with prednisone, we will continue to check on you by telephone for up to 10 years.
Knight Cancer Institute Clinical Trials information line: 503-494-1080 or firstname.lastname@example.org
Oregon Health & Science University (OHSU)