Abiraterone + Prednisone for Prostate Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding two medications, abiraterone acetate (Zytiga) and prednisone, to the usual prostate cancer treatment can lower prostate-specific antigen (PSA) levels and slow cancer growth. Researchers aim to identify any side effects from these medications. Men with prostate cancer currently on hormone therapy without cancer spread may be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any antiandrogen therapy, such as bicalutamide, flutamide, or nilutamide, before participating. If you were previously on these medications, there are specific timeframes you must wait after stopping them before joining the trial.

Is there any evidence suggesting that abiraterone acetate and prednisone are likely to be safe for humans?

Previous studies have shown that the combination of abiraterone acetate and prednisone is generally well-tolerated. Research indicates that this treatment can extend the lives of patients with prostate cancer. Serious side effects occurred less frequently in those receiving this treatment compared to standard care, with 64.1% experiencing more severe side effects compared to 71.8% on standard care.

Common side effects include fatigue, joint pain, and high blood pressure. These can be managed, and doctors closely monitor them. Overall, the safety of abiraterone and prednisone is well-documented, making it a suitable option for many patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about using abiraterone acetate combined with prednisone for prostate cancer because it takes a unique approach to treatment. Unlike typical hormone therapies that block testosterone production at the testicles, abiraterone acetate goes further by also inhibiting testosterone production in other parts of the body, like the adrenal glands and the cancer itself. This broader targeting can potentially lead to more effective suppression of cancer growth. Additionally, combining abiraterone with prednisone helps manage potential side effects and supports better overall treatment outcomes.

What evidence suggests that abiraterone acetate plus prednisone is effective for prostate cancer?

Research has shown that the combination of abiraterone acetate and prednisone, which participants in this trial will receive, can effectively treat prostate cancer. Studies have found that this treatment can extend patients' lives, regardless of prior chemotherapy or docetaxel use. In one study, patients taking abiraterone experienced an average of 33 months without cancer growth, compared to 14.8 months for those on a placebo. Additionally, real-world evidence supports these findings, indicating that this treatment is both effective and safe for many patients. Overall, abiraterone acetate plus prednisone has demonstrated a significant benefit in delaying the progression of prostate cancer. ^{2 5 6 7 8}

Who Is on the Research Team?

Janssen Services, LLC. Clinical Trial

Principal Investigator

Janssen Biotech, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33826036/

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.

sciencedirect.com

sciencedirect.com/science/article/pii/S2059702922000527

Real-world experience of abiraterone acetate plus ...

In 481 chemotherapy-naive mCRPC patients (median follow-up: 25 months), abiraterone plus prednisone was effective and safe.

5.

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 ...

6.

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.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00485303?term=AREA%5BInterventionSearch%5D(YONSA)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=6

An Efficacy and Safety Study of Abiraterone Acetate and ...

The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which ...

8.

mdpi.com

mdpi.com/2072-6694/17/17/2747

The Safety of Abiraterone Acetate in Patients with ...

More serious adverse events (grade 3 or 4) and deaths (grade 5) occurred in those receiving SOC (71.8%) compared to abiraterone (64.1%). The most frequent ...