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Antiandrogen

Apalutamide Before Surgery for Prostate Cancer

Phase 2

Waitlist Available

Led By John W Davis

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Normal coagulation profile and no history of substantial non-iatrogenic bleeding diathesis

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Must not have

Clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events in the past 6 months, severe or unstable angina, class III-IV New York Heart Association heart failure

Other malignancy, except non-melanoma skin cancer, that is active or has a >= 30% probability of recurrence within 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how effective apalutamide is in treating prostate cancer before surgery. It may work by lowering androgen levels, which could make radiation therapy after surgery unnecessary.

Who is the study for?

Men with intermediate-risk prostate cancer, suitable for surgery, and no metastases. They must have a testosterone level above 200 ng/mL, agree to use contraception during the trial and for 3 months after, be able to swallow tablets, and not have other serious health issues or another active malignancy.

What is being tested?

The trial is testing apalutamide's effectiveness in treating prostate cancer before surgical removal of the prostate. Apalutamide is a hormone therapy that lowers androgen levels which may reduce the need for radiation post-surgery.

What are the potential side effects?

Apalutamide can cause fatigue, high blood pressure, skin rash, falls or fractures due to bone weakness; digestive issues like diarrhea; weight loss; joint pain; hot flushes; swelling in limbs; headache.

Eligibility Criteria

Inclusion Criteria

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

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My blood clotting is normal and I don't have a history of unusual bleeding.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidney function is good.

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My prostate cancer diagnosis was confirmed through a tissue examination.

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My cancer is extensive enough for a major lymph node surgery, as agreed by a surgeon.

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I can swallow pills without any difficulty.

Exclusion Criteria

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

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I have had serious heart issues like a heart attack or severe heart failure recently.

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I do not have an active cancer other than non-melanoma skin cancer or one likely to return within a year.

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I have stomach or intestine problems that could affect how I absorb medication.

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I am not a candidate for prostate surgery due to other serious health issues.

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My cancer is not adenocarcinoma but another type like neuroendocrine, small cell, or sarcomatoid.

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I have active hepatitis or chronic liver disease.

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I have had hormone therapy for prostate cancer.

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I do not have any serious illnesses or infections that are not under control.

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I have a history of pituitary or adrenal disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 to 5 years

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

Aggregate Pathologic Risk Features

Secondary study objectives

Adverse Events (AE_) of Neoadjuvant Apalutamide Followed by Radical Prostatectomy

Biochemical Recurrence Rate

Estimation of the frequency of clinical complete responses (pT0) and "near" complete responses (<6mm total tumor volume)

+1 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

1Treatment groups

Experimental Treatment

Group I: Treatment (apalutamide, radical prostatectomy)Experimental Treatment3 Interventions

Patients receive apalutamide PO daily for 24 weeks in the absence of disease progression or unacceptable toxicity. Within 2 weeks of completing apalutamide, patients undergo radical prostatectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radical Prostatectomy

2005

Completed Phase 2

~4550

Apalutamide

2015

Completed Phase 2

~5750