Abiraterone/Prednisone + ADT for Prostate Cancer

Overseen By Taylor Johnson, MA

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Nebraska

Must be taking: ADT

Must not be taking: HIV antivirals

Disqualifiers: Metastatic disease, Uncontrolled diabetes, 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: 3 months to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores improved methods for treating prostate cancer by combining hormone therapy with radiation. Researchers compare a new treatment, which includes the drugs abiraterone and prednisone (a corticosteroid), with standard hormone therapy to determine which is more effective over five years. Participants must have prostate cancer with specific lymph node involvement identified by a PSMA-PET scan and no prior treatments. The goal is to determine if the new combination offers better survival rates and fewer side effects. This study could influence future prostate cancer treatments. As a Phase 2 trial, the research focuses on assessing 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 information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance based on your situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining abiraterone and prednisone with standard hormone therapy is generally well-tolerated by patients with prostate cancer. While most people taking abiraterone experience some side effects, this is common with many cancer treatments. In one study, 98.4% of patients experienced side effects, similar to other treatments. However, these effects are usually manageable.

Abiraterone is already approved for treating advanced prostate cancer, indicating that doctors understand its safety. Studies have also shown that it helps patients live longer. This combination treatment might cause common side effects like tiredness or high blood pressure, but doctors closely monitor these.

Overall, abiraterone and prednisone have been used safely in many patients, and the side effects are similar to those of other prostate cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for prostate cancer?

Researchers are excited about the combination of Abiraterone and Prednisone with standard ADT for prostate cancer because it offers a new approach by enhancing hormone therapy. Unlike traditional treatments that focus solely on hormone reduction, this combination also targets androgen production more effectively, which may slow cancer progression more significantly. This dual-action approach could potentially lead to better outcomes for patients by tackling the cancer from multiple angles.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that adding abiraterone and prednisone to standard hormone therapy can help treat prostate cancer. In this trial, participants in one arm will receive this combination with standard hormone therapy. One study found that this combination lowered the risk of death by 24% in patients with metastatic prostate cancer. Another study found that it extended the time patients lived without cancer spreading and improved overall survival rates. Patients also experienced less bone pain and better results in PSA tests, which monitor prostate cancer. These findings suggest that abiraterone and prednisone can effectively improve outcomes for prostate cancer patients. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for prostate cancer patients with PSMA-positive but conventional imaging negative pelvic lymphadenopathy. Participants should not have lymph nodes larger than 1cm in smallest diameter and must be suitable for hormone therapy and radiation.

Inclusion Criteria

I can give my informed consent to participate in the study.

I can swallow pills.

My prostate cancer diagnosis was confirmed by a pathology review.

Exclusion Criteria

Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse

I cannot have radiation therapy due to certain health conditions.

My cancer has spread beyond the pelvic area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either enhanced ADT with abiraterone and prednisone or standard ADT, both with concurrent radiation therapy

3 months to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Abiraterone/Prednisone

Trial Overview The study compares enhanced ADT using abiraterone and prednisone with standard ADT, both combined with radiation therapy, to see which is more effective for the specified prostate cancer condition over a period of five years.

How Is the Trial Designed?

Group I: Abiraterone/Prednisone + Standard ADT Experimental Treatment 1 Intervention

Abiraterone/Prednisone Combination plus Standard Hormone Therapy

Group II: Standard ADT Active Control 1 Intervention

Standard Hormone Therapy

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Citations

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

Abiraterone plus Prednisone in Metastatic, Castration- ... In STAMPEDE, a significant 24% risk reduction in death was observed among patients with metastatic, castration-sensitive prostate cancer. (The ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11560831/

Efficacy of abiraterone combined with prednisone in ... Conclusions: Abiraterone combined with prednisone effectively relieves bone pain and improves PSA response rates in CRPC patients, suggesting benefits in ...

3. thelancet.com thelancet.com/article/S0140-6736(21)02437-5/fulltext

Abiraterone acetate and prednisolone with or without ... Our results suggest a clear improvement in metastasis-free and overall survival from the addition of 2 years of abiraterone to ADT in men with ...

4. esmoopen.com esmoopen.com/article/S2059-7029(22)00052-7/fulltext

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. •. QoL, measured ...

5. cancer.gov cancer.gov/types/prostate/research/abiraterone

Abiraterone Improves Survival in Metastatic Prostate Cancer Among the 797 patients randomly assigned to receive abiraterone acetate plus the corticosteroid prednisone, median overall survival was 14.8 ...

6. 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 ...

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

The Safety of Abiraterone Acetate in Patients with ... We observed a higher incidence of overall adverse events with the use of abiraterone acetate (98.4%) compared to (97.3%), though given the distribution of ...

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 ...