Anti-androgen Treatment for Prostate Cancer

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Must be taking: Anti-androgens

Disqualifiers: Active malignancy, Cardiovascular disease, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4-7 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how hormone therapy for prostate cancer affects heart health. Researchers will use MRI scans to assess heart function before and after 4 to 7 months of hormone therapy. It is designed for individuals with confirmed prostate cancer who are about to start hormone treatment, provided their cholesterol is below 200 mg/dL and they can safely undergo moderate exercise and MRI scans. The goal is to help plan better treatments and improve comfort for patients with prostate cancer. As an unphased trial, this study offers patients the opportunity to contribute to important research that may enhance future treatment strategies.

Do I need to stop taking my current medications for this 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.

Is there any evidence suggesting that hormone therapy is likely to be safe for humans?

Research shows that hormone therapy for prostate cancer is usually well-tolerated, but some risks exist. Some studies have found that patients on hormone therapy might face a higher risk of heart problems, especially older men, including a greater chance of dying from heart-related diseases.

However, not everyone experiences these side effects, and many people use hormone therapy without major issues. Discuss these risks and benefits with a doctor when considering treatment options. Always monitor how the body reacts to the therapy and report any concerns to a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new insights into how hormone therapy affects the heart and muscles in prostate cancer patients. Unlike typical approaches that focus solely on cancer treatment, this study uses advanced imaging techniques like cardiac MRI and skeletal muscle PMRS to measure the impact of anti-androgen therapy on cardiovascular and muscular health. This could lead to a better understanding of how to manage not just the cancer itself but also the overall well-being of patients undergoing hormone therapy.

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

Research has shown that hormone therapy, including drugs called anti-androgens, effectively treats prostate cancer. Studies indicate that newer anti-androgens can significantly improve outcomes, such as reducing cancer recurrence and preventing its spread. Hormone therapy lowers male hormone levels that promote prostate cancer growth. This treatment has extended the lives of prostate cancer patients, resulting in better survival rates. Overall, hormone therapy is a well-supported option for managing prostate cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Steven Clinton, MD, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer who are about to start at least 4 months of hormone therapy. They should be in good physical condition (ECOG status 0-1), have cholesterol and triglycerides levels below 200 mg/dL, normal kidney and liver function tests, a complete blood count within the normal range, and no significant clotting disorders.

Inclusion Criteria

I have been diagnosed with prostate cancer through a biopsy.

Have plasma triglycerides < 200 mg/dL

I am about to start a specific hormone therapy for at least 4 months.

Exclusion Criteria

I have no heart-related reasons preventing me from doing exercise tests.

I am being treated for a cancer other than prostate cancer.

I have a heart condition or severe illness that makes moderate exercise unsafe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a treadmill stress CMR and skeletal muscle PMRS before initiation of ADT treatment

1 day

1 visit (in-person)

Treatment

Participants receive anti-androgen treatment (ADT) for 4-7 months

4-7 months

Post-Treatment Assessment

Participants undergo a treadmill stress CMR and skeletal muscle PMRS 4-7 months after initiation of ADT treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hormone Therapy

Trial Overview The study uses cardiac MRI to assess how anti-androgen treatments affect heart function in prostate cancer patients. Participants will undergo MRIs before starting hormone therapy and after 4 to 7 months on treatment to monitor changes in their cardiac health.

How Is the Trial Designed?

Group I: Diagnostic (cardiac MRI, skeletal muscle PMRS) Experimental Treatment 5 Interventions

Patients undergo a treadmill stress CMR focused on cardiac muscle comprised of resting MRI over 10-15 minutes followed by treadmill exercise until peak stress. Patients then undergo MRI and gadopentetate dimeglumine perfusion imaging immediately after exercise and after a 6-8 minute recovery period. Within 24 hours of treadmill CMR exam, patients also undergo skeletal muscle PMRS while at rest, during, and in the recovery phase of resistive lower extremity exercise which patients complete over 30 seconds. Both procedures are performed before initiation of ADT treatment (baseline) and 4-7 months after initiation of ADT treatment.

Hormone Therapy is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Hormone Therapy for:

• Breast cancer
• Hormone receptor-positive breast cancer

Approved in United States as Hormone Therapy for:

• Breast cancer
• Hormone receptor-positive breast cancer
• Stage I-III breast cancer

Approved in Canada as Hormone Therapy for:

• Breast cancer
• Hormone receptor-positive breast cancer

Approved in Japan as Hormone Therapy for:

• Breast cancer
• Hormone receptor-positive breast cancer

Approved in Switzerland as Hormone Therapy for:

• Breast cancer
• Hormone receptor-positive breast cancer

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Pelontonia

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

Letrozole, a third-generation aromatase inhibitor, effectively lowers estrogen levels in postmenopausal women and has been shown to be more effective than tamoxifen in treating hormone-receptor-positive early breast cancer.

Clinical trials indicate that letrozole significantly improves disease-free survival, particularly in high-risk patients, making it a crucial option in adjuvant therapy for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the use of letrozole in breast cancer. Wu, M., Goss, PE.[2019]

Letrozole has been fully approved by the FDA for treating postmenopausal women with hormone receptor-positive early breast cancer, showing a significant improvement in disease-free survival compared to tamoxifen, with a hazard ratio of 0.87 in the adjuvant trial.

While letrozole is effective, it is associated with a higher risk of bone fractures and myocardial infarction compared to tamoxifen, which has its own risks such as endometrial cancer and thromboembolic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approval summary: letrozole (Femara® tablets) for adjuvant and extended adjuvant postmenopausal breast cancer treatment: conversion of accelerated to full approval. Cohen, MH., Johnson, JR., Justice, R., et al.[2021]

Hormonal treatment for prostate cancer aims to reduce androgen levels, and various methods like orchiectomy and medications can achieve this effectively, with all methods showing similar efficacy.

While orchiectomy is a safe procedure, it may have psychological effects, and other treatments like estrogens and synthetic hormone analogs have their own risks, making patient preference and side effects important factors in treatment selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hormonal therapy of prostate cancer: current concepts and future prospects. Smith, JA.[2005]

Abiraterone acetate combined with prednisone significantly improves overall survival (34.7 months vs 30.3 months) and radiologic progression-free survival (16.5 months vs 8.3 months) in patients with metastatic castration-resistant prostate cancer compared to placebo.

The treatment is generally well-tolerated, with manageable side effects primarily related to mineral corticoid excess, and it also enhances the perceived quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Abiraterone in castration resistant prostate cancer.] Juárez Soto, A., Caballero Cobos, R., Campanario Pérez, R., et al.[2018]

Letrozole, an aromatase inhibitor, has been shown to be significantly more effective than tamoxifen in treating advanced breast cancer, particularly in terms of median time to progression and response rates, while being well tolerated by patients.

Anastrozole and exemestane also provide effective alternatives to tamoxifen, with anastrozole showing equivalent efficacy overall but superior results in hormone receptor-positive patients, and exemestane demonstrating better response rates, although overall survival data is still pending.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aromatase inhibitors in advanced breast cancer. Mouridsen, HT.[2019]

In a study of 40 postmenopausal women with locally advanced breast cancer, both Letrozole and Tamoxifen were found to be effective as neoadjuvant hormone therapies, with 25% of patients on Tamoxifen and 20% on Letrozole not achieving a complete response, leading to subsequent radiotherapy.

The study indicated that neoadjuvant hormone therapy was generally well-tolerated, with side effects occurring in 55% of patients on Letrozole and 60% on Tamoxifen, suggesting that these treatments could improve clinical outcomes and allow for successful radical mastectomy in patients with better prognoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Letrozole vs. tamoxifen as neoadjuvant therapy for postmenopausal patients with hormone-dependent locally-advanced breast cancer]. Novoa Vargas, A., Font López, KC., Amador, DD.[2018]

Anastrozole and letrozole significantly improve disease-free survival compared to tamoxifen in postmenopausal women with early-stage breast cancer, based on results from Phase III trials.

Switching to an aromatase inhibitor like anastrozole or exemestane after 2 to 3 years of tamoxifen therapy reduces the risk of cancer recurrence more effectively than continuing tamoxifen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are all aromatase inhibitors the same? A review of controlled clinical trials in breast cancer. Berry, J.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9007137/

Endocrine therapies for breast and prostate cancers Adjuvant tamoxifen therapy for 5 to 10 years is associated with a statistically significant absolute breast cancer mortality reduction at 15 years (mean [SD] ...

2. ahajournals.org ahajournals.org/doi/10.1161/HCG.0000000000000082

Impact of Hormonal Therapies for Treatment ... This consensus statement describes the risks associated with specific hormonal therapies used to treat breast and prostate cancer and provides an evidence- ...

3. cedars-sinai.org cedars-sinai.org/newsroom/new-combined-therapy-helps-extend-lives-of-men-with-prostate-cancer/

New Combined Therapy Helps Extend Lives of Men With ... Research from Cedars-Sinai shows that a combination of therapies significantly improves outcomes for prostate cancer patients.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1558767325000473

Efficacy of Neoadjuvant Hormonal Therapy for High-Risk ... NHT with second-generation antiandrogens has shown significant improvements in oncological outcomes, including BCR and MFS, compared with RP alone (P < .001 for ...

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2775931

Efficacy of Endocrine Therapy for the Treatment of Breast ... In premenopausal women the addition of GnRHa leads to an improved disease-free survival, and in prostate cancer the use of a GnRHa improves ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2588931124000282

A 3-year Interim Analysis of the Observational J-ROCK Study In this study, we compared clinical and safety outcomes with different treatment regimens, using a large series of patients with high-risk metastatic hormone- ...

7. ecancer.org ecancer.org/en/news/22066-hormone-therapy-for-prostate-cancer-increases-the-risk-of-dying-from-cardiovascular-disease

Hormone therapy for prostate cancer increases the risk of ... Hormone therapy for prostate cancer increases the risk of cardiovascular disease-related death especially in older men, according to a population study.

8. professional.heart.org professional.heart.org/en/science-news/Impact-of-Hormonal-Therapies-for-Treatment-of-Hormone-Dependent-Cancers-Breast-and-Prostate-on-the-C/commentary

Hormonal Based Therapies in the Treatment of Breast and ... Explore the potential cardiovascular impacts of hormonal therapies for the treatment of hormone-dependent breast & prostate cancer with ...