What is the mechanism of action of this treatment?

Common treatments for prostate cancer, particularly hormone-sensitive types, focus on altering hormone levels to inhibit tumor growth. Androgen deprivation therapy (ADT) reduces androgen levels through surgical or medical means, such as LHRH agonists and antagonists, which lower testosterone. Newer antiandrogens like enzalutamide block androgen receptors, while abiraterone inhibits androgen production. These treatments are vital as they target the hormonal pathways essential for prostate cancer cell growth, thereby slowing disease progression and improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly hormone therapies like androgen deprivation therapy (ADT), enzalutamide, and abiraterone, are associated with several side effects. These include cardiovascular toxicities, hypertension, fatigue, decreased libido, erectile dysfunction, hot flashes, and metabolic changes such as weight gain and loss of muscle mass. Long-term hormone suppression can also increase the risk of osteoporosis and fractures.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that focus on altering hormone levels to inhibit tumor growth. Androgen deprivation therapy (ADT) is a cornerstone of treatment, often combined with androgen receptor signaling inhibitors such as enzalutamide, apalutamide, and darolutamide. These agents have shown significant improvements in metastasis-free survival in patients with castration-resistant prostate cancer (CRPC). Additionally, abiraterone acetate, used in combination with prednisone, has been approved for its efficacy in prolonging survival in CRPC patients. These treatments are based on robust clinical trial data demonstrating their effectiveness in managing hormone-sensitive prostate cancer.

What other types of research exist?

Promising alternatives to oral hormone therapy for prostate cancer patients include: 1) Androgen Deprivation Therapy (ADT) combined with novel antiandrogens like enzalutamide or abiraterone, which have shown improved survival and quality of life in clinical trials. 2) Chemohormonal therapy, such as the combination of ADT with docetaxel, which has demonstrated long-term survival benefits. 3) Bipolar Androgen Therapy (BAT), an investigational approach involving cyclical high-dose testosterone therapy, which has shown potential in resensitizing castration-resistant prostate cancer to further androgen-directed therapies.

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Hormone Therapy

Hormone Therapy + Radiation for Prostate Cancer

N/A

Waitlist Available

Led By Stanley Liauw, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing if taking hormone pills can improve the quality of life and survival rates for patients who need hormone-based treatment. The pills work by adjusting hormone levels in the body to help manage their condition.

Who is the study for?

Men aged 18+ with intermediate or high-risk prostate cancer who haven't had radical surgery, hormonal therapy, or certain other treatments for prostate cancer. They should have a life expectancy of at least 10 years and be able to give informed consent. Men with severe health issues like unstable angina, active infections needing IV antibiotics, liver problems, AIDS, or autoimmune diseases are excluded.

What is being tested?

The trial is testing if oral hormone therapies (Bicalutamide, Dutasteride, Finasteride) plus radiation improve quality of life and survival rates compared to standard care in men with prostate cancer. It's looking at how well patients do on these drugs versus the usual treatment.

What are the potential side effects?

Possible side effects from the hormone therapies may include breast tenderness/enlargement, hot flashes, reduced sex drive/erectile function; while radiation can cause fatigue, skin changes in treated area and urinary/bowel symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire

Secondary study objectives

Percentage of Participants Free From Biochemical Failure

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oral Androgen TherapyExperimental Treatment4 Interventions

Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation

2003

Completed Phase 2

~780

Finasteride

FDA approved

Bicalutamide

FDA approved

Dutasteride

FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer, particularly hormone-sensitive types, focus on altering hormone levels to inhibit tumor growth. Androgen deprivation therapy (ADT) reduces androgen levels through surgical or medical means, such as LHRH agonists and antagonists, which lower testosterone. Newer antiandrogens like enzalutamide block androgen receptors, while abiraterone inhibits androgen production. These treatments are vital as they target the hormonal pathways essential for prostate cancer cell growth, thereby slowing disease progression and improving patient outcomes.

Screening and hormonal therapy of localized prostate cancer shows major benefits on survival.