Abemaciclib + Hormone Therapy for Prostate Cancer

(RAD 1805 Trial)

Overseen By Andrew McDonald, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Must be taking: Androgen deprivation therapy

Must not be taking: CDK4-6 inhibitors

Disqualifiers: Cardiovascular disease, Hepatitis, AIDS, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 4

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of abemaciclib (a cancer-fighting drug) and hormone therapy to evaluate their effectiveness in treating high-risk prostate cancer. Researchers aim to determine if adding abemaciclib to standard hormone treatments and radiation can improve outcomes for those with prostate cancer confined to the prostate. This trial targets individuals diagnosed with localized high-risk or locally advanced prostate cancer who are considering radiation therapy. Candidates must have confirmed prostate cancer with specific Gleason scores and no prior systemic cancer treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer treatment.

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

The trial does not specify if you need to stop taking your current medications. However, prior treatment with systemic anti-cancer agents is not allowed, so you may need to discuss your current medications with the study team.

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

Research has shown that abemaciclib is generally well tolerated by patients with advanced prostate cancer. One study found that abemaciclib alone was effective and did not cause severe side effects for most participants, even those with extensive prior treatments.

Androgen deprivation therapy (ADT) is another component of the treatment. It effectively shrinks tumors and lowers PSA levels, a protein linked to prostate cancer, in over 90% of patients. However, ADT can cause side effects such as sexual problems and changes in physical appearance.

Overall, both treatments have demonstrated safety in similar contexts. However, like any treatment, side effects may occur, so discussing expectations with the study team is important. ^{1 2 3 4 5}

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

Researchers are excited about the combination of Abemaciclib with hormone therapy for prostate cancer because it introduces a new angle in treatment. Unlike traditional treatments that primarily focus on androgen deprivation therapy (ADT) alone, this approach adds Abemaciclib, a CDK4/6 inhibitor, which targets cancer cell division and growth. This combination, along with radiation therapy, aims to enhance the overall effectiveness against prostate cancer by attacking the cancer cells on multiple fronts, potentially leading to better outcomes for patients.

What evidence suggests that this treatment might be an effective treatment for prostate cancer?

Studies have shown that abemaciclib can slow the progression of prostate cancer. One study found that patients taking abemaciclib with another drug experienced stable cancer for about 22 months. Androgen deprivation therapy (ADT) has lowered male hormone levels and slowed cancer growth for over 80 years. In this trial, participants will receive a combination of abemaciclib, ADT, and radiation therapy, which might further improve outcomes for those with high-risk or advanced prostate cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Andrew McDonald, MD

Principal Investigator

University of Alabama at Birmingham (UAB)

Are You a Good Fit for This Trial?

Men with high-risk or advanced prostate cancer that hasn't spread, who haven't had systemic anti-cancer treatments. They must have a certain level of health, including normal organ function and blood counts, be able to perform daily activities with ease or some difficulty (ECOG PS=0 or 1), and agree to use contraception.

Inclusion Criteria

Adequate hematologic and end-organ function: ANC ≥ 1500/mm3, Platelet count ≥ 100,000/mm3, Hb ≥ 9g/dl, Creatinine ≤ ULN or Creatinine Clearance (CrCl) ≥ 60 ml/min, Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert syndrome, who can have total Bilirubin > 2.0 x ULN and direct bilirubin within normal limits are permitted), AST, ALT and alkaline phosphatase ≤ ULN, Agreement to remain abstinent or use appropriate contraception, Willingness and ability to consent for self to participate in study, Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

I have at least one measurable cancer lesion.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have active hepatitis or cirrhosis.

I have an active autoimmune disease or a history of inflammatory bowel disease, and I cannot receive brachytherapy boost.

I have a cancer other than prostate cancer that doesn't need further treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abemaciclib in combination with androgen deprivation therapy (ADT) and radiation therapy (RT). ADT starts 3 months before RT, and abemaciclib is paused 2 weeks prior to RT and resumes 1 month post-RT.

24 months

Visits every 4 weeks for laboratory evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abemaciclib
• Androgen deprivation therapy (ADT)

Trial Overview The trial is testing the effectiveness and safety of abemaciclib pills taken twice daily in combination with standard hormone therapy for prostate cancer. Participants will also receive radiation therapy as part of their treatment.

How Is the Trial Designed?

Group I: Abemaciclib + ADT+ RT Experimental Treatment 3 Interventions

Abemaciclib at 150 mg by mouth twice daily, androgen deprivation therapy (ADT), and radiation therapy in conjunction with ADT.

Abemaciclib is already approved in United States, European Union for the following indications:

Approved in United States as Verzenio for:

• Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Approved in European Union as Verzenio for:

• HR+, HER2- advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41167216/

Abemaciclib plus abiraterone in patients with metastatic ... Median radiographic progression-free survival was 22·0 months (95% CI 19·3-27·5) for abemaciclib plus abiraterone and 20·3 months (16·5-24·4) for placebo plus ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03706365

NCT03706365 | A Study of Abiraterone Acetate Plus ... This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1470204525004759

Abemaciclib plus abiraterone in patients with metastatic ... Median radiographic progression-free survival was 22·0 months (95% CI 19·3–27·5) for abemaciclib plus abiraterone and 20·3 months (16·5–24·4) for placebo plus ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38512117/

A Signal-Finding Study of Abemaciclib in Heavily ... Efficacy analyses are as follows: ORR without concurrent bone progression: 6.8%; disease control rate: 45.5%; median time to PSA progression: ...

5. aacrjournals.org aacrjournals.org/clincancerres/article-pdf/30/11/2377/3454552/2377.pdf

A Signal-Finding Study of Abemaciclib in Heavily Pretreated ... Results: At trial entry, 40 (90.9%) of 44 patients had objective radiographic disease progression, 4 (9.1%) had prostate-specific antigen (PSA)–only progression ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05288166

NCT05288166 | A Study of Abemaciclib (LY2835219) With ... The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04408924?term=AREA%5BExpandedAccessNCTId%5DNCT03763604&rank=7&tab=results

Study Results | Abemaciclib (LY2835219) in Men With ... A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11145166/

A Signal-Finding Study of Abemaciclib in Heavily ... Conclusions: Abemaciclib monotherapy was well tolerated and showed clinical activity in this heavily pretreated population, nearly half with visceral ...