What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as Apalutamide (an androgen receptor inhibitor) combined with GnRH agonists (which reduce testosterone production), have a range of side effects. Apalutamide can cause fatigue, hypertension, rash, diarrhea, and falls, while GnRH agonists are associated with hot flashes, decreased libido, erectile dysfunction, osteoporosis, and an increased risk of acute kidney injury. Combining these treatments may lead to a compounded side effect profile, requiring careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that are similar to the combination of Apalutamide (an androgen receptor inhibitor) and GnRH agonists (which reduce testosterone production). Notable androgen receptor inhibitors include Enzalutamide and Darolutamide, which, like Apalutamide, block the androgen receptor signaling pathway. GnRH agonists such as Leuprolide and Goserelin are commonly used to lower testosterone levels. These treatments are often used in combination to enhance efficacy, particularly in advanced or castration-resistant prostate cancer.

What other types of research exist?

Promising alternatives to Apalutamide plus GnRH agonist for prostate cancer treatment in 2024 include: 1) Bicalutamide plus LHRH-A, which has shown better tolerability and similar efficacy compared to flutamide. 2) Enzalutamide plus ADT, which is effective for castration-resistant prostate cancer. 3) Bipolar Androgen Therapy (BAT), which may restore sensitivity to other treatments like enzalutamide and abiraterone. These alternatives offer different benefits and should be discussed with a healthcare provider to determine the best option based on individual patient needs.

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Androgen Receptor Inhibitor

Apalutamide + Hormone Therapy for Prostate Cancer

Q: What is the mechanism of action of this treatment?

Prostate cancer treatments often target the androgen pathway, crucial for prostate cancer cell growth. Androgen receptor inhibitors like Apalutamide block the androgen receptor, preventing testosterone from stimulating cancer cells. GnRH agonists reduce testosterone production by initially stimulating and then downregulating the release of gonadotropins from the pituitary gland. This dual approach is significant for prostate cancer patients as it effectively reduces the hormonal signals that drive cancer progression, potentially improving outcomes and delaying metastasis.

Phase 3

Waitlist Available

Research Sponsored by Aragon Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1

Age >= 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 108 months

Awards & highlights

Study Summary

This trial will test whether adding apalutamide to standard hormone therapy can help men with high-risk prostate cancer that has not spread live longer without the disease progressing.

Who is the study for?

Men over 18 with high-risk, localized or locally advanced prostate cancer who are set to receive primary radiation therapy. They must be in good health with a low Charlson index (<=3), able to swallow pills, and have normal liver function and adequate blood counts. Participants should not have had prior treatments for prostate cancer, no history of seizures or conditions that may cause them, and agree to use condoms.Check my eligibility

What is being tested?

The trial is testing if adding apalutamide plus GnRH agonist to the standard radiation treatment improves survival without metastasis in men with high-risk prostate cancer. It compares this combination against placebo versions while all participants receive radiation therapy.See study design

What are the potential side effects?

Apalutamide can cause fatigue, rash, joint pain, falls, fractures, hot flushes, diarrhea, nausea; it might also affect thyroid function. GnRH agonists typically lead to symptoms like hot flashes and reduced sexual interest due to lower testosterone levels.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I am 18 years old or older.

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I can swallow pills without any difficulty.

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My prostate cancer is aggressive based on its Gleason score and PSA levels.

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I am scheduled for initial radiation therapy for prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 108 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~108 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 108 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Metastasis-free survival

Secondary outcome measures

Event-free Survival

MFS by Conventional or Positron Emission Tomography (PET) Imaging

Overall Survival (OS)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ApalutamideExperimental Treatment4 Interventions

Participants will receive apalutamide (240 mg), by mouth, once daily for overall 30 months, plus bicalutamide placebo, by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.

Group II: Control groupActive Control4 Interventions

Participants will receive apalutamide placebo, by mouth, once daily for overall 30 months, plus bicalutamide (50 mg), by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apalutamide

2015

Completed Phase 2

~3310

0 / 5Eligibility 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

Prostate cancer treatments often target the androgen pathway, crucial for prostate cancer cell growth. Androgen receptor inhibitors like Apalutamide block the androgen receptor, preventing testosterone from stimulating cancer cells. GnRH agonists reduce testosterone production by initially stimulating and then downregulating the release of gonadotropins from the pituitary gland. This dual approach is significant for prostate cancer patients as it effectively reduces the hormonal signals that drive cancer progression, potentially improving outcomes and delaying metastasis.