IRB #

STUDY00016728

Title

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

Principal Investigator

Julie Graff

Study Purpose

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.

Medical Condition(s)

Newly diagnosed metastatic prostate cancer.

Eligibility Criteria

-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

Age Range

18 - 110

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials information line: 503-494-1080 or trials@ohsu.edu

Sponsor

Oregon Health & Science University (OHSU)

Recruitment End

12/31/2027

Compensation Provided

No


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