Abiraterone + Prednisone for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Abiraterone, Prednisone

Must not be taking: Azole drugs, Flutamide

Disqualifiers: Uncontrolled hypertension, Severe hepatic impairment, others

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

Compensation: Varies

Number of Visits: 6

Duration: 2 years

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a method to detect prostate cancer cells in the blood without a biopsy. The goal is to understand how prostate cancer responds to Abiraterone (Zytiga) and Prednisone, drugs that treat advanced prostate cancer by blocking male hormones. Researchers will test participants' blood to observe changes in circulating tumor cells (CTCs) in response to these treatments. Ideal candidates for this trial have advanced prostate cancer that has spread and have undergone previous anti-androgen therapy. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to less invasive detection methods.

What prior data suggests that this method to detect circulating tumor cells is safe?

Research shows that abiraterone acetate, when combined with prednisone, is generally well-tolerated by many prostate cancer patients. Studies have found that this combination can extend life expectancy, even for those who haven't undergone chemotherapy or have previously received docetaxel.

In terms of safety, this treatment tends to have fewer serious side effects compared to some standard treatments. Serious side effects occur less frequently in patients taking abiraterone than in those receiving standard care. Common side effects include fatigue, joint pain, and swelling. Prednisone helps reduce some of these side effects.

Both abiraterone acetate and prednisone have approval for treating certain conditions, which provides some confidence in their safety. However, like any treatment, risks exist, so potential trial participants should discuss these with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of Abiraterone Acetate and Prednisone for prostate cancer because it offers a novel approach to hormone therapy. Unlike traditional treatments that may target testosterone production more broadly, Abiraterone specifically inhibits an enzyme called CYP17, crucial in testosterone synthesis, reducing cancer growth more effectively. This targeted action, combined with Prednisone to manage side effects, has the potential to improve patient outcomes by slowing disease progression in a more focused manner than existing therapies.

What is the effectiveness track record for Abiraterone Acetate and Prednisone in treating prostate cancer?

Research has shown that taking abiraterone acetate with prednisone helps patients with advanced prostate cancer live longer and significantly delays disease progression. One study found that patients using these medications experienced an average of 33 months before their cancer worsened, compared to 14.8 months for those not on the treatment. Additionally, many patients saw a significant drop in their PSA levels, a marker for prostate cancer, with over 64% experiencing a reduction of 50% or more. Due to these positive results, this treatment is approved for advanced prostate cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Richard Lee, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for men with advanced prostate cancer that has spread and doesn't respond to hormone therapy. Participants must have a confirmed diagnosis, be able to swallow tablets, agree to fast before taking the study drug, use effective birth control, and have a life expectancy of over 6 months. They should not have severe symptoms from their cancer or liver metastases.

Inclusion Criteria

My prostate cancer diagnosis was confirmed through lab tests.

My cancer progressed after stopping hormone therapy.

Willing to use a method of birth control with adequate barrier protection

Exclusion Criteria

I do not have any infections or conditions that prevent me from using steroids.

I have not taken bicalutamide or nilutamide in the last 6 weeks.

My prostate cancer is of the small cell type.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive abiraterone acetate and prednisone, with regular clinic visits for assessments and monitoring

2 years

3 visits in the first 2 months, then monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

End of Study Treatment Visit

Final assessments and tests are conducted 15-28 days after treatment discontinuation

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Abiraterone Acetate
• Prednisone

Trial Overview The study tests Abiraterone acetate combined with Prednisone in patients with metastatic castration-resistant prostate cancer (CRPC). It aims to evaluate how circulating tumor cells (CTCs) in blood can indicate the tumor's response to this treatment without needing a biopsy.

How Is the Trial Designed?

Group I: Abiraterone acetate with Prednisone Experimental Treatment 2 Interventions

1000 mg Abiraterone daily by mouth, 4 x 250 mg tablets Prednisone administered as 5 mg orally twice a day

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?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

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. 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 ( ...

3. 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9058899/

Real-world experience of abiraterone acetate plus prednisone ... A PSA response (≥50%) during abiraterone treatment was achieved by 272 patients (64.2% of 424 patients with available information; 59.9% of all ...

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. 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.

7. 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 ...

8. 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 ...