What side effects are associated with this type of intervention?

Androgen Deprivation Therapy (ADT) for prostate cancer can lead to several side effects, including dysregulated glucose metabolism, increased risk of diabetes, cardiovascular disease, weight gain, loss of muscle mass, decreased bone mineral density, and fatigue. Radiation Therapy (RT) can cause urinary symptoms, diarrhea, and potential long-term effects such as changes in bowel habits and sexual dysfunction. Both treatments aim to inhibit cancer growth but come with a range of potential side effects that should be managed with the help of healthcare professionals.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that involve Androgen Deprivation Therapy (ADT) and Radiation Therapy. ADT aims to reduce androgen levels to inhibit cancer cell growth and includes drugs like leuprolide, goserelin, and degarelix, which are gonadotropin-releasing hormone (GnRH) agonists or antagonists. Additionally, antiandrogens such as bicalutamide, enzalutamide, and apalutamide block androgen receptors. Radiation Therapy, often combined with ADT, directly kills cancer cells and is a standard treatment for localized and locally advanced prostate cancer. These therapies have been shown to improve survival and delay disease progression in various stages of prostate cancer.

What other types of research exist?

Promising novel alternatives to ADT and RT for prostate cancer patients include: 1) Bipolar Androgen Therapy (BAT) - This involves alternating between high and low levels of testosterone to disrupt cancer cell adaptation. 2) PARP Inhibitors - These target cancer cells with specific genetic mutations (e.g., BRCA1/2) and have shown efficacy in metastatic castration-resistant prostate cancer (mCRPC). 3) Immunotherapy - Agents like pembrolizumab (a PD-1 inhibitor) are being explored for their potential to harness the immune system against prostate cancer. 4) Radioligand Therapy - This involves targeting cancer cells with radioactive substances, such as Lutetium-177-PSMA, which has shown promise in mCRPC. 5) Next-Generation Antiandrogens - Drugs like enzalutamide and apalutamide offer more targeted androgen receptor inhibition with potentially fewer side effects.

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Hormone Therapy

ADT + Radiation +/- Abiraterone & Apalutamide for Prostate Cancer

Phase 2

Waitlist Available

Led By Paul Nguyen, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

PSA ≥ 0.1 after radical prostatectomy within 3 months of registration and at least 1 unfavorable risk factor

Age between 18 and 95 at the time of consent

Must not have

Current evidence of uncontrolled hypertension, gastrointestinal disorder affecting absorption, active infection, chronic medical conditions requiring high-dose corticosteroids, or any condition precluding study participation

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new drug combinations with radiation for men whose prostate cancer has returned after surgery. These drugs aim to block testosterone more effectively than current treatments to improve cure rates. Enzalutamide, a next generation selective androgen receptor antagonist, is approved by the FDA for use in prostate cancer treatment.

Who is the study for?

Men aged 18-95 with prostate cancer who've had surgery but now have rising PSA levels. They must have a Gleason score of 8-10, fast PSA doubling time, and good organ function. Men must agree to use contraception and not donate sperm during the study.

What is being tested?

The trial is testing two ADT combinations with radiation for prostate cancer patients post-surgery with rising PSA. It's seeing if adding Abiraterone and Apalutamide to standard treatment offers better outcomes.

What are the potential side effects?

Possible side effects include hot flashes, fatigue, joint pain, high blood pressure, liver issues from Abiraterone/Prednisone; seizures or rash from Apalutamide; skin irritation from radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My PSA level is 0.1 or higher after prostate surgery, and I have at least one risk factor.

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I am between 18 and 95 years old.

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My prostate cancer diagnosis was confirmed through a tissue examination.

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I am eligible for additional radiation and hormone therapy.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled high blood pressure, serious gut problems, ongoing infections, or conditions needing high-dose steroids.

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I do not have any unmanaged ongoing illnesses.

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My cancer has spread to my bones, confirmed by scans.

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My liver is not working well.

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I am not currently being treated for another cancer nor at high risk of cancer returning within 5 years.

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I have a history of seizures or conditions that could lead to seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

PSA Progression Free Survival

Secondary study objectives

Cardiovascular events consisting of myocardial infarction

Cause Specific Survival

Metastasis Free Survival on conventional imaging or pathologically (MFS)

+6 more

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250

74%

Hot flashes

71%

Fatigue

44%

Anemia

38%

Hyperglycemia

26%

AST increase

26%

Hypertension

26%

Lipase increase

24%

ALT increase

24%

Dry skin

21%

Rash

18%

ACTH increase

18%

Cholesterol high

15%

Dizziness

15%

Amylase increase

12%

Memory impairment

12%

White blood cell decrease

12%

Constipation

12%

Lymphocyte count decrease

Myalgia

Paresthesia

Weight loss

Arthralgia

Hypothyrodism

LDH increase

Erectile dysfunction

Headache

Personality change

Dysgeusia

Dyspnea

HbA1c increased

Hypertriglyceridemia

Insomnia

Irritability

Anorexia

Atrial fibrillation

Anxiety

Bruising

Hypercalcemia

Dehydration

TSH increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

Arm A (LHRHa, Apalutamide)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: GnRH+Abiraterone+Apalutamide+PrednisoneExperimental Treatment5 Interventions

* GnRH agonist injection monthly or every 3 months for 6 months * Abiraterone acetate by mouth once/day for 6 months * Prednisone by mouth once/day for 6 months * Apalutamide by mouth once/day for 6 months * Salvage radiation (starting 4-10 weeks after initiation of ADT)

Group II: GnRH + BicalutamideExperimental Treatment3 Interventions

* GnRH agonist injection monthly or every 3 months for 6 months * Bicalutamide by mouth once/day for 6 months * Salvage radiation (starting 4-10 weeks after initiation of ADT)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GnRH

2017

Completed Phase 2

~640

Bicalutamide

2003

Completed Phase 3

~6210

Abiraterone

2012

Completed Phase 4

~4570

Prednisone

2014

Completed Phase 4

~2500

Apalutamide

2015

Completed Phase 2

~5660

0 / 11Eligibility criteria met

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

Androgen Deprivation Therapy (ADT) reduces androgen levels, which are hormones that stimulate prostate cancer cell growth, thereby inhibiting cancer cell proliferation. Radiation Therapy uses high-energy rays to directly kill cancer cells by damaging their DNA, preventing them from growing and dividing. Understanding these mechanisms is crucial for prostate cancer patients as it helps them grasp how these treatments target cancer cells, potentially improving treatment adherence and side effect management.