Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial

Conditions

• Recurrent Prostate Carcinoma
• Stage III Prostate Adenocarcinoma AJCC v7
• Stage IV Prostate Adenocarcinoma AJCC v7

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Apalutamide — DRUG
  Given PO
• External Beam Radiation Therapy — RADIATION
  Undergo external beam radiation therapy
• Placebo Administration — OTHER
  Given PO

Study Details

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.

Key Dates

Start date

Jun 20, 2018

Status verified

Jan 2026

Primary completion

Mar 10, 2025

Completion

Mar 1, 2026

Study Design

Enrollment

324 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1 (radiation therapy, placebo)
  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.
• Experimental: Arm 2 (radiation therapy, apalutamide)
  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.

Primary Outcome Measure

Biochemical progression-free survival (bPFS) [ Time Frame: From randomization to the first occurrence of a rise in PSA, clinical or radiographic local, regional, or distant metastases, or death from any cause, assessed up to 5 years ]

Locations (352)

Find similar trials in Gilbert, AZ

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