130 Participants Needed

Abiraterone + Prednisone for Prostate Cancer

(APRE Trial)

Recruiting at 2 trial locations
CT
MM
Overseen ByMartha Mims, MD, PhD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Martha Mims
Must be taking: Abiraterone, Prednisone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years. The reason for the study is that researchers think that there may be a connection between the race and ethnicity of men with prostate cancer and how well the standard treatments work for the participants.

Will I have to stop taking my current medications?

The trial does not require a washout period for antiandrogens or five alpha reductase inhibitors, so you may not need to stop these medications. However, you cannot take ketoconazole, aminoglutethimide, or enzalutamide during the trial.

What data supports the effectiveness of the drug Abiraterone Acetate plus Prednisone for prostate cancer?

Research shows that Abiraterone Acetate combined with Prednisone significantly improves survival and delays disease progression in patients with metastatic castration-resistant prostate cancer, especially those who have not received chemotherapy before.12345

Is Abiraterone + Prednisone safe for humans?

Abiraterone acetate combined with prednisone is generally considered safe for treating prostate cancer, but it can cause side effects like low potassium levels, high blood pressure, fluid retention, and liver issues. These side effects were relatively low in frequency in clinical studies.12678

How is the drug Abiraterone Acetate with Prednisone unique for prostate cancer?

Abiraterone Acetate with Prednisone is unique because it blocks the production of androgens (male hormones) that fuel prostate cancer growth, and is taken orally, making it more convenient than some other treatments. It is particularly effective for patients with metastatic castration-resistant prostate cancer, significantly improving survival and delaying disease progression compared to standard treatments.12469

Research Team

MM

Martha Mims, MD, PhD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

Men with metastatic hormone naive prostate cancer who have not received certain prior treatments like ketoconazole or chemotherapy for metastasis. They must be over 18, have adequate organ function, and a Zubrod performance status of 0-2 (3 if due to bone pain). Prior surgery is okay after recovery, and they can't have severe heart issues or known brain metastases.

Inclusion Criteria

I had surgery over 2 weeks ago and have recovered from major side effects.
Patients must have a PSA ≥ 10 ng/mL obtained within 90 days prior to registration.
I am taking or plan to take bone-strengthening drugs that don't affect PSA levels.
See 15 more

Exclusion Criteria

I do not have brain metastases.
I haven't had chemotherapy for metastatic prostate cancer but may have had it earlier with a curative goal.
I am not allergic to abiraterone or LHRH agonists.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abiraterone acetate and prednisone as per standard of care until disease progression

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 months

Long-term follow-up

Participants are followed for up to 10 years to assess long-term outcomes

Up to 10 years

Treatment Details

Interventions

  • Abiraterone Acetate
  • Prednisone
Trial OverviewThe study examines the effectiveness of standard care treatment with abiraterone acetate and prednisone in men with prostate cancer across different races/ethnicities. Participants will be followed for up to 10 years to see how well these treatments work.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Abiraterone acetate + prednisoneExperimental Treatment2 Interventions
All subjects will receive abiraterone acetate and prednisone, as per standard of care. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone twice per day. Subjects will continue to take abiraterone acetate and prednisone until confirmed disease progression.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Martha Mims

Lead Sponsor

Trials
1
Recruited
130+

Findings from Research

Oral abiraterone acetate (Zytiga®) significantly improves overall survival and progression-free survival in patients with metastatic castration-resistant prostate cancer (CRPC) when used with prednisone, compared to a placebo.
The treatment is specifically effective for patients who have already undergone docetaxel-containing chemotherapy, highlighting its role as a subsequent therapy in advanced prostate cancer management.
Abiraterone acetate: a guide to its use in metastatic castration-resistant prostate cancer.Scott, LJ., Yang, LPH., Lyseng-Williamson, KA.[2021]
In a phase 3 trial involving 1199 patients, the addition of abiraterone acetate and prednisone to androgen-deprivation therapy significantly improved overall survival, with a median survival not reached in the abiraterone group compared to 34.7 months in the placebo group.
The study also showed that patients receiving abiraterone had a median radiographic progression-free survival of 33.0 months, compared to 14.8 months in the placebo group, indicating a strong benefit in delaying disease progression.
Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer.Fizazi, K., Tran, N., Fein, L., et al.[2022]
Abiraterone acetate, in combination with prednisone, received full FDA approval for treating metastatic castration-resistant prostate cancer (mCRPC) based on the COU-AA-302 trial, which involved 1,088 patients and showed a significant improvement in radiographic progression-free survival (rPFS) compared to placebo (8.3 months vs. not reached).
The trial also indicated a favorable trend in overall survival (OS) for patients receiving abiraterone acetate, although it did not reach statistical significance, confirming the drug's efficacy and safety profile consistent with previous studies.
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary.Kluetz, PG., Ning, YM., Maher, VE., et al.[2018]

References

Abiraterone acetate: a guide to its use in metastatic castration-resistant prostate cancer. [2021]
Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. [2022]
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary. [2018]
Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. [2022]
Abiraterone acetate plus prednisolone with or without enzalutamide for patients with metastatic prostate cancer starting androgen deprivation therapy: final results from two randomised phase 3 trials of the STAMPEDE platform protocol. [2023]
Assessment of the Safety of Glucocorticoid Regimens in Combination With Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer: A Randomized, Open-label Phase 2 Study. [2022]
Abiraterone acetate: a review of its use in patients with metastatic castration-resistant prostate cancer. [2021]
Real-world evidence in patient-reported outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate + prednisone (AA+P) across Canada: Final results of COSMiC. [2020]
Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). [2022]