Abiraterone + Prednisone for Prostate Cancer

Recruiting at 44 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Janssen Biotech, Inc.

Must be taking: Gonadotropin-releasing hormone

Must not be taking: Antiandrogens, CYP17 inhibitors

Disqualifiers: Metastatic disease, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

131 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.

Research Team

Janssen Services, LLC. Clinical Trial

Principal Investigator

Janssen Biotech, Inc.

Eligibility Criteria

Men over 18 with prostate cancer, currently on GnRH therapy or who've had testicular surgery, can join. They need a rising PSA level and must be able to swallow pills. Excluded are those with recent antiandrogen therapy, active hepatitis/liver disease, other cancers (except certain skin cancers), heart issues, uncontrolled diabetes/hypertension, or prior treatments affecting CYP17 enzyme.

Inclusion Criteria

Be willing/able to adhere to the prohibitions and restrictions specified in this protocol

I can take care of myself and am up and about more than half of my waking hours.

I can swallow pills whole.

Exclusion Criteria

My cancer has spread or gotten worse according to specific criteria.

Have received an investigational therapeutic within 30 days of screening

Have partners of childbearing potential and are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Core Study Treatment

Participants receive abiraterone acetate plus prednisone for six 28-day cycles

Approximately 6 months

Pre-metastatic Disease Follow-up

Participants are monitored for disease progression without radiographic evidence of metastasis

Up to 30.5 months

Optional Drug Holiday

Participants may discontinue treatment and resume if PSA rises without metastasis

Up to 1 year

Safety Follow-up

Participants return for a safety follow-up visit 30 days after the last dose

1 month

Treatment Details

Interventions

• Abiraterone Acetate
• Prednisone

Trial Overview The trial tests if adding abiraterone acetate plus prednisone to standard care lowers PSA levels and delays cancer growth in men with prostate cancer already receiving GnRH therapy or post-testicular removal.

Participant Groups

Group I: 001 Experimental Treatment 1 Intervention

abiraterone acetate in combination with prednisone Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.

Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Metastatic high-risk castration-sensitive prostate cancer

Approved in European Union as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer

Approved in Canada as Zytiga for:

• Metastatic castration-resistant prostate cancer
• Metastatic castration-sensitive prostate cancer

Approved in Japan as Zytiga for:

• Prostate cancer

Who Is Running the Clinical Trial?

Janssen Biotech, Inc.

Lead Sponsor

Trials

30

Recruited

18,800+