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Apalutamide + Radiation for Prostate Cancer (BALANCE Trial)

Phase 2

Waitlist Available

Led By Daniel Spratt, MD

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

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

Must have

>= T3a disease

Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration

Must not have

Active uncontrolled infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)

Uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Summary

This trial is testing how well radiation therapy works when combined with or without the drug apalutamide to treat patients with stage III-IV prostate cancer.

Who is the study for?

Men with stage III-IV prostate cancer who've had a prostatectomy within the last 10 years, have certain PSA levels, and meet specific health criteria can join. They must not have had prior chemotherapy for prostate cancer or radiotherapy overlapping the treatment area, among other exclusions.

What is being tested?

The trial is testing if adding apalutamide to radiation therapy improves outcomes in treating prostate cancer compared to radiation alone. Apalutamide blocks androgens which may fuel cancer growth.

What are the potential side effects?

Apalutamide could cause fatigue, high blood pressure, rash, diarrhea, weight loss, fractures and falls. Radiation might lead to skin changes at the treated site, tiredness and more frequent urination.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is at least stage T3a.

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I can care for myself and am able to carry on normal activities.

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My surgical sample is available for genomic analysis or I already have the results for validation.

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I agree not to donate sperm during and for 3 months after the study.

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My PSA levels are between 0.1 and 1.0 ng/mL after prostate surgery.

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My prostate cancer is aggressive (Gleason score 7-10).

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My PSA levels have been consistently high after prostate surgery, but not above 0.2 ng/mL.

Exclusion Criteria

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

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I do not have an active, uncontrolled infection like HIV or hepatitis.

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My high blood pressure is not under control.

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My cancer has spread to other parts of my body or lymph nodes.

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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.

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I have a documented history of inflammatory bowel disease.

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I have not had cryoablation or HIFU for prostate cancer.

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I have had radiation in the same area where my current cancer is located.

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I have a digestive condition that affects how my body absorbs pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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

Biochemical Progression-free survival (bPFS)

Secondary study objectives

Acute Patient-Reported Morbidity (per the patient reported outcomes [PRO]- Common Terminology Criteria for Adverse Events [CTCAE])

Acute Physician-Reported Morbidity (per the Common Terminology Criteria for Adverse Events [CTCAE] version 5)

Cancer-Specific Mortality (CSM)

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 2 (Radiation Therapy + Apalutamide)Experimental Treatment2 Interventions

Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive apalutamide PO QD on Days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months)in the absence of disease progression or unacceptable toxicity.

Group II: Arm 1 (Radiation Therapy + Placebo)Placebo Group2 Interventions

Patients undergo external beam radiation therapy on Day 1 for 7.5 weeks. Beginning on Day 1 of radiation therapy, patients receive placebo PO QD on Days 1-30. Treatment repeats every 30 days for up to 6 courses (6 months) in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

External Beam Radiation Therapy

2006

Completed Phase 3

~3300

Apalutamide

2015

Completed Phase 2

~5660