Abiraterone + Prednisone for Prostate Cancer

(APRE Trial)

Recruiting at 2 trial locations

Overseen By Martha Mims, MD, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Martha Mims

Must be taking: Abiraterone, Prednisone

Must not be taking: Ketoconazole, Aminoglutethimide, Enzalutamide

Disqualifiers: Brain metastases, Heart failure, 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

Duration: Up to 3 years

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how race and ethnicity might influence the success of standard treatments for prostate cancer. Participants will take abiraterone acetate (Zytiga) and prednisone, medications commonly used for prostate cancer treatment. The study will monitor men with prostate cancer for up to 10 years to evaluate the performance of these drugs. Men diagnosed with metastatic prostate cancer, currently receiving standard hormone treatments, may be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the combination of abiraterone acetate and prednisone is generally well-tolerated in men with prostate cancer. This treatment targets prostate cancer that has metastasized. Long-term use of abiraterone is considered safe for patients with stable heart conditions.

However, some risks exist. This combination may increase the risk of bone fractures and other serious effects when used with certain drugs, such as radium 223 dichloride. Participants should discuss potential side effects with their healthcare provider to ensure safety during treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of Abiraterone Acetate and Prednisone for treating prostate cancer because it targets the production of androgens, which are hormones that fuel the growth of prostate cancer cells. Unlike many existing treatments that typically focus on blocking androgen receptors, Abiraterone Acetate works by inhibiting an enzyme called CYP17, crucial for androgen production. This dual approach could potentially offer a more effective way to slow down or stop the progression of prostate cancer compared to standard treatments alone.

What is the effectiveness track record for abiraterone acetate and prednisone in treating prostate cancer?

Research has shown that using abiraterone acetate with prednisone can help treat prostate cancer. Studies have found that this combination significantly extends patients' lives. For those with metastatic prostate cancer, the time before the disease progressed was much longer for those who received this treatment compared to those who did not. Another study found that adding this treatment to hormone therapy helped men with advanced prostate cancer live longer. Overall, these findings suggest that abiraterone acetate and prednisone effectively slow the disease and extend the lives of prostate cancer patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Martha Mims, MD, PhD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Abiraterone Acetate
• Prednisone

Trial Overview The 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.

How Is the Trial Designed?

Group I: Abiraterone acetate + prednisone Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Martha Mims

Lead Sponsor

Trials

1

Recruited

130+

Published Research Related to This Trial

In a study of 254 metastatic castration-resistant prostate cancer patients treated with abiraterone acetate plus prednisone (AA+P) over a median follow-up of 67.1 weeks, patient-reported outcomes (PROs) showed no significant decline in quality of life or cognitive function, indicating that the treatment is well-tolerated.

The study also reported a 66.4% response rate in prostate-specific antigen (PSA) levels, demonstrating the efficacy of AA+P in managing this patient population while maintaining their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Gotto, G., Drachenberg, DE., Chin, J., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Abiraterone acetate significantly improves overall survival and radiographic progression-free survival in men with metastatic castration-resistant prostate cancer (CRPC) when combined with prednisone, based on results from a multinational phase III study involving men who had previously received docetaxel.

The treatment is generally well-tolerated, although it can cause side effects like hypokalaemia and hypertension; however, serious adverse events were relatively low in the phase III studies, indicating it is a viable option for managing metastatic CRPC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abiraterone acetate: a review of its use in patients with metastatic castration-resistant prostate cancer. Hoy, SM.[2021]

In a phase 3 trial with 1088 patients, abiraterone acetate plus prednisone significantly improved overall survival compared to placebo plus prednisone, with a median survival of 34.7 months versus 30.3 months, indicating its efficacy in treating chemotherapy-naive castration-resistant prostate cancer.

The treatment was associated with a manageable safety profile, although there were some increased risks of grade 3-4 adverse events, such as cardiac disorders and elevated liver enzymes, suggesting that while effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ryan, CJ., Smith, MR., Fizazi, K., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. Fizazi, K., Tran, N., Fein, L., et al.[2022]

In a study of 1088 patients with metastatic castration-resistant prostate cancer (mCRPC), abiraterone acetate combined with prednisone significantly improved radiographic progression-free survival (rPFS) compared to prednisone alone, with a median rPFS of 16.5 months versus 8.2 months.

Abiraterone acetate also showed a trend towards improved overall survival (OS) with a median of 35.3 months compared to 30.1 months for prednisone, indicating a potential benefit in prolonging life, while maintaining a favorable safety profile over long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Rathkopf, DE., Smith, MR., de Bono, JS., et al.[2022]

In a clinical trial involving 164 men with metastatic castration-resistant prostate cancer, abiraterone acetate combined with prednisone (5 mg twice daily) or dexamethasone (0.5 mg once daily) effectively minimized mineralocorticoid excess, which is important for patient safety.

While abiraterone with dexamethasone showed promising efficacy, it was also linked to adverse metabolic effects, such as increased insulin resistance and decreased bone mineral density, highlighting the need for careful monitoring of these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Attard, G., Merseburger, AS., Arlt, W., et al.[2022]

In a study involving 1919 patients with metastatic prostate cancer, the addition of abiraterone acetate to standard androgen deprivation therapy significantly improved overall survival, with a median survival of 76.6 months compared to 45.7 months for standard care alone.

Combining both abiraterone and enzalutamide did not provide additional survival benefits over abiraterone alone, and it was associated with higher rates of severe side effects, suggesting that this combination should be avoided in long-term treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Attard, G., Murphy, L., Clarke, NW., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8105236/

Real-World Safety and Efficacy Outcomes with Abiraterone ... Abiraterone acetate plus prednisone or prednisolone (AAP) prolongs survival in chemotherapy-naive and docetaxel-experienced patients.

2. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2025.43.5_suppl.367

Real-world discontinuation and efficacy data of abiraterone ... Background: Data from STAMPEDE trial confirmed Overall survival benefit for patients with high-risk localized or locally advanced prostate ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1704174

Abiraterone plus Prednisone in Metastatic, Castration- ... The median length of radiographic progression-free survival was 33.0 months in the abiraterone group and 14.8 months in the placebo group ( ...

4. zytigahcp.com zytigahcp.com/efficacy-and-safety/

Metastatic High-Risk CSPC LATITUDE Study A major efficacy outcome was overall survival. The pre-specified interim analysis after 406 deaths showed a statistically significant improvement in OS in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30987939/

Abiraterone acetate plus prednisone in patients with newly ... The combination of abiraterone acetate plus prednisone with ADT was associated with significantly longer overall survival than placebos plus ADT in men with ...

6. zytigahcp.com zytigahcp.com/important-safety-information/

Important Safety Information ZYTIGA® (abiraterone acetate) is indicated in combination with prednisone for the treatment of patients with: metastatic castration-resistant prostate cancer ( ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34050660/

Safety and efficacy of abiraterone acetate plus ... This study evaluated the safety and efficacy of abiraterone acetate plus prednisolone in castration-resistant prostate cancer patients with or without previous ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/abiraterone-oral-route/description/drg-20074889

Abiraterone (oral route) - Side effects & dosage Abiraterone and prednisone/prednisolone may increase your risk for bone fractures and death when used together with radium 223 dichloride ( ...

9. zytiga.com zytiga.com/

Prescription Treatment with ZYTIGA® (abiraterone acetate ... ZYTIGA® is used to treat men with prostate cancer that has spread to other parts of the body. ZYTIGA® is not for use in women. It is not known if ZYTIGA ® is ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4981293/

Safety of long-term exposure to abiraterone acetate in patients ... Long-term abiraterone treatment was well tolerated in mCRPC patients with controlled cardiovascular comorbidities/risk factors, with no apparent worsening of ...