Apalutamide + Radiation for Prostate Cancer

(BALANCE Trial)

Recruiting at415 trial locations

Overseen by Felix Y Feng

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NRG Oncology

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with prostate cancer that has come back (recurrent). Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer compared to radiation therapy alone.

Research Team

Felix Y Feng

Principal Investigator

NRG Oncology

Eligibility Criteria

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.

Inclusion Criteria

My cancer is at least stage T3a.

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

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

Exclusion Criteria

For patients who have not undergone prior Decipher analysis, submission of the specimen to GenomeDx should be as soon as possible after study registration (Step 1) as these results can take up 21 days after the specimen is received at GenomeDx; Step 2 registration must occur within 6 weeks (42 days) of Step 1 registration; if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation

Patients must not plan to participate in any other clinical trials while receiving treatment on this study or being followed post-protocol therapy.

I have had seizures or conditions that increase my risk of seizures, like a stroke within the last year.

Treatment Details

Interventions

• Apalutamide (Antiandrogen)
• External Beam Radiation Therapy (Radiation)

Trial Overview 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.

Participant Groups

Group I: Arm 2 (radiation therapy, apalutamide) Experimental Treatment 2 Interventions

Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive apalutamide PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm 1 (radiation therapy, placebo) Active Control 2 Interventions

Patients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive placebo PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

External Beam Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Japan as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in China as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Switzerland as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School