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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

BALANCE Trial 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.Check my eligibility

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.See study design

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.

BALANCE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer is at least stage T3a.

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

Select...

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.

Select...

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

Select...

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

BALANCE Trial 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

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

Primary outcome measures

Biochemical Progression-free survival (bPFS)

Secondary outcome measures

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

BALANCE 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

~3070

Apalutamide

2015

Completed Phase 2

~3310

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor

231 Previous Clinical Trials

100,541 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,842 Total Patients Enrolled

Daniel Spratt, MDPrincipal InvestigatorNRG Oncology

3 Previous Clinical Trials

205 Total Patients Enrolled

Media Library

External Beam Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03371719 — Phase 2

Prostate-Specific Antigen Research Study Groups: Arm 2 (Radiation Therapy + Apalutamide), Arm 1 (Radiation Therapy + Placebo)

Prostate-Specific Antigen Clinical Trial 2023: External Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT03371719 — Phase 2

External Beam Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03371719 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many health care centers are actively participating in this trial?

"This clinical trial is presently being conducted at 100 different sites, with outposts in San Antonio, Salt Lake City and Lexington as well as a plethora of other locations. It is advisable to select the closest site possible to reduce traveling expenditures if you decide to partake."

Answered by AI

Can you please explain the risks of External Beam Radiation Therapy for patients?

"Based on our assessment, External Beam Radiation Therapy achieved a safety score of 2 as the procedure remains in Phase 2 trials; there is some evidence that it can be safely applied but no data yet demonstrating its effectiveness."

Answered by AI

Have prior studies been conducted with External Beam Radiation Therapy?

"Currently, 44 live medical studies are exploring the efficacy of External Beam Radiation Therapy with 15 trials in their final stage. Although most of these experiments take place in South Weymouth, Massachusetts, there are an additional 2417 sites conducting similar research."

Answered by AI

How many individuals are eligible for enrollment in this research trial?

"This experiment is not presently enrolling participants. It was first posted on April 27th 2018 and its last update occured on March 9th 2022. For those seeking out other trials, 1968 are actively recruiting patients with advanced stage of prostate adenocarcinoma and 44 clinical studies for External Beam Radiation Therapy require volunteers at this time."

Answered by AI

Is this experiment unprecedented in its scope and approach?

"Since 2014, External Beam Radiation Therapy has been the subject of numerous clinical trials. The very first trial, sponsored by Aragon Pharmaceuticals Inc., involved 982 patients and resulted in its Phase 3 drug approval. Currently, 44 studies on this method are underway across 38 countries and 552 cities."

Answered by AI

Are there still vacancies open for participants in this clinical experiment?

"According to clinicaltrials.gov, this investigation is no longer recruiting individuals for participation. The trial was initially made available on April 27th 2018 and was modified most recently on March 9th 2022; however, 2012 other studies are actively looking for volunteers currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BIOMARKER TRIAL of APALUTAMIDE and RADIATION for RECURRENT PROSTATE CANCER

2018. "BIOMARKER TRIAL of APALUTAMIDE and RADIATION for RECURRENT PROSTATE CANCER". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03371719.

All > Recurrent Prostate Cancer