Abiraterone for Prostate Cancer

(Drugs-SNPs Trial)

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair

Must be taking: Abiraterone, Prednisone, Bicalutamide

Must not be taking: Other anti-cancer therapies

Disqualifiers: Other cancer, Serious illness, 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: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment for prostate cancer using a drug called Abiraterone, often combined with other medications. Researchers aim to determine how genetic differences might influence the treatment's effectiveness and safety. Participants will receive either the usual form of Abiraterone or a version imported from China. Men diagnosed with prostate cancer that has not spread outside the prostate and who have not undergone prostate surgery may be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

If you are currently on a different chemotherapy, you must stop it to join this trial. If you are on other anti-cancer therapies that cannot be stopped, you cannot participate.

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

Research has shown that patients generally tolerate abiraterone well. Almost all study participants experienced at least one side effect, but these were often similar to those seen with standard treatments. Importantly, abiraterone does not increase the risk of serious side effects compared to standard care.

Real-world evidence supports these findings, indicating that abiraterone is both effective and safe for treating prostate cancer. Most clinical trials with abiraterone have demonstrated positive results, achieving a high success rate in meeting their objectives. This suggests that abiraterone is a reliable treatment option, with a safety profile comparable to other standard treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments in this trial because they explore new formulations of abiraterone, a key medication for prostate cancer. Unlike standard treatments, which often rely on familiar formulations, these treatments incorporate abiraterone acetate tablets combined with prednisone and BICALUTAMIDE, but with a unique twist: one arm uses ZYTIGA, a well-known brand, while the other uses a China-imported version. This comparison could reveal differences in efficacy or side effects between the formulations, potentially leading to more tailored treatment options for patients.

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

Studies have shown that abiraterone effectively treats prostate cancer. In one study, abiraterone helped patients live longer on average and slowed cancer progression. Nearly all trials testing abiraterone have shown positive results, with 89% achieving their goals. In this trial, participants will receive either the usual approach with abiraterone or a study-specific formulation. Another study found that patients taking abiraterone experienced longer periods without cancer worsening compared to those not taking it. These findings suggest abiraterone can be a strong option for managing prostate cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

HAN XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

HAN XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

HAN XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

Are You a Good Fit for This Trial?

Men with prostate cancer that's still within the prostate, who haven't had orchiectomy or prostate resection, and have stopped any previous different chemotherapy can join. They must not be on other anti-cancer therapies, have serious illnesses, multiple cancers, severe drug allergies or bleeding tendencies. Participants need to sign a consent form and agree to blood draws.

Inclusion Criteria

I have had treatments for my condition without having my testicles surgically removed.

I have had prostate cancer treatment without surgery to remove the prostate.

I have stopped any previous chemotherapy treatments.

Exclusion Criteria

Treatment with other anti-cancer therapies and the therapies cannot be stopped currently

I have more than one type of cancer.

I have a condition that causes serious bleeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive combined chemotherapy with ZYTIGA - abiraterone acetate tablet, prednisone tablet, and BICALUTAMIDE tablet to study the relationship between Abiraterone therapeutic efficacy and SNP genotyping

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CoronaVac® plus TICE® BCG Mix
• COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection
• Licorice Combination Separate Dietary Supplements Oral
• Licorice DS plus Ginkgo DS plus Ginger DS plus Aloe DS

Trial Overview The trial is testing if genetic differences (SNPs) affect how well Abiraterone works for treating prostate cancer. It compares usual treatment with a study approach in two groups of 300 men each using blind random assignment. Both groups receive combined chemotherapy including Abiraterone.

How Is the Trial Designed?

Group I: Abiraterone - Usual Experimental Treatment 1 Intervention

* ZYTIGA - Abiraterone * Combined Chemotherapy * ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet * Usual Approach Group

Group II: Abiraterone - Study Experimental Treatment 1 Intervention

* China Import - Abiraterone * Combined Chemotherapy * China Import - abiraterone acetate tablet plus prednisone tablet plus BICALUTAMIDE tablet * Usual Approach Group

Who Is Running the Clinical Trial?

Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair

Lead Sponsor

Trials

4

Recruited

1,200+

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Lead Sponsor

Trials

6

Recruited

2,400+

Citations

1. e-juo.org e-juo.org/journal/view.php?number=594

Assessing Patient Risk, Benefit, and Outcomes in Drug ... Nearly all clinical trials testing abiraterone in prostate cancer showed promising outcomes with 89% of studies meeting their endpoint.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40531349/

The efficacy of abiraterone in metastatic hormone-sensitive ... Results: Data for 3374 patients were analyzed. In the overall population, abiraterone improved OS (HR: 0.66, 95% CI 0.59-0.73) and PFS (HR: 0.51, 95% CI ...

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. ecancer.org ecancer.org/en/news/26791-lower-dose-of-abiraterone-acetate-as-effective-for-prostate-cancer-treatment

Lower dose of abiraterone acetate as effective for prostate ... In their study involving nine men with metastatic prostate cancer, they found that this lower dose resulted in comparable cancer suppression.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4530380/

Comparative analysis of the effectiveness of abiraterone ... Abiraterone was associated with significantly increased radiographic-progression-free survival, objective response rate, and prostate-specific antigen response ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40940844/

The Safety of Abiraterone Acetate in Patients with Metastatic ... Nearly all participants experienced at least one adverse event (98.4% abiraterone, 97.3% standard of care [SOC]).

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

The Safety of Abiraterone Acetate in Patients with ... Conclusions: In this IPD meta-analysis, abiraterone acetate provides no greater risk of SAE in those receiving abiraterone than those receiving SOCs. Patients ...

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

Real-World Safety and Efficacy Outcomes with Abiraterone ... Real-world data from this registry confirm the efficacy and safety of first- and second-line abiraterone acetate in patients with mCRPC, including a subset who ...

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

Metastatic High-Risk CSPC LATITUDE Study The median follow-up time was 52 months. Results from this analysis were consistent with those from the pre-specified interim analysis. At the updated analysis, ...