What side effects are associated with this type of intervention?

Common treatments for prostate cancer, especially those involving androgen receptor inhibitors like apalutamide, can have a range of side effects. Apalutamide, for instance, is associated with fatigue, hypertension, rash, diarrhea, and falls. Other similar treatments, such as enzalutamide, may also cause seizures, cognitive impairment, and increased risk of infections. Docetaxel, often used in combination with androgen deprivation therapy (ADT), can lead to neutropenia, diarrhea, and fatigue. Overall, while these treatments can be effective, they come with a significant risk of adverse effects that should be carefully managed in clinical practice.

What prior FDA approvals exist?

The FDA has approved several androgen receptor inhibitors for the treatment of prostate cancer, including apalutamide, enzalutamide, and darolutamide. Apalutamide was approved for metastatic castration-sensitive prostate cancer (CSPC) based on studies showing significant improvements in overall survival and radiographic progression-free survival. Enzalutamide has also been approved for both metastatic and nonmetastatic castration-resistant prostate cancer (CRPC) and CSPC, demonstrating benefits in overall survival and disease progression. Darolutamide, another androgen receptor inhibitor, has been approved for nonmetastatic CRPC and in combination with docetaxel for metastatic CSPC, showing a significant reduction in the risk of death and consistent benefits across various endpoints.

What other types of research exist?

Promising novel alternatives to Apalutamide for prostate cancer patients include Enzalutamide and Darolutamide, both of which are androgen receptor inhibitors. Additionally, taxane-based chemotherapies like Docetaxel and Cabazitaxel have shown efficacy in castration-resistant prostate cancer. Emerging therapies such as Lutetium-177-PSMA-617 (Pluvicto) and Bipolar Androgen Therapy (BAT) are also noteworthy options.

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Apalutamide + ADT for Prostate Cancer (PROTEUS Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Histologically confirmed adenocarcinoma of the prostate.

High risk disease (Gleason Score of 7 or greater).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing if using apalutamide and hormone therapy around the time of surgery can help men with high-risk prostate cancer by reducing the hormones that help the cancer grow.

Who is the study for?

Men with high-risk, localized or locally advanced prostate cancer who are candidates for surgery to remove the prostate and pelvic lymph nodes. They must be willing to undergo 13 months of treatment, have a Gleason Score of at least 7, no distant metastasis (M0 stage), and not have had prior treatments for prostate cancer or certain cardiovascular events in the past year.

What is being tested?

The trial is testing if adding apalutamide to standard hormone therapy before and after surgical removal of the prostate improves outcomes like complete response rate and survival without metastasis compared to placebo plus hormone therapy.

What are the potential side effects?

Apalutamide can cause fatigue, rash, joint pain, falls, fractures, hot flushes, diarrhea, nausea. Androgen deprivation therapy may lead to sexual dysfunction, hot flashes, reduced bone density/muscle mass and changes in mood.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is confirmed by tissue analysis.

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My prostate cancer is considered high risk.

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

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Men who are participating in the study and their female partners who can become pregnant need to use approved birth control methods according to local regulations for people participating in clinical trials.

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I am willing to undergo 13 months of treatment and can continue hormone therapy if not surgically castrated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

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

Metastasis-Free Survival (MFS)

Percentage of Participants with Pathologic complete response (pCR)

Secondary study objectives

Event Free Survival (EFS)

MFS Based on Conventional Imaging

Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability

+7 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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo + ADTExperimental Treatment2 Interventions

Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment.

Group II: Apalutamide + ADTExperimental Treatment2 Interventions

Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Androgen Deprivation Therapy (ADT)

2005

Completed Phase 3

~610

Placebo

1995

Completed Phase 3

~2670

Apalutamide

2015

Completed Phase 2

~5710

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 receptor pathway, which is crucial for the growth and survival of prostate cancer cells. Androgen deprivation therapy (ADT) reduces androgen levels, thereby limiting cancer cell growth. Androgen receptor inhibitors like apalutamide and enzalutamide block the androgen receptor, preventing androgens from stimulating cancer cells. Abiraterone inhibits androgen production by blocking the enzyme CYP17. These treatments are vital as they effectively slow disease progression and improve survival rates in prostate cancer patients by disrupting the hormonal signals that drive cancer growth.