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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Recurrent Prostate Carcinoma, Stage III Prostate Adenocarcinoma AJCC v7, Stage IV Prostate Adenocarcinoma AJCC v7

In brief

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 facts

Study ID

NCT03371719

Run by

NRG Oncology

People needed

298

Starts

2018-06-20

Expected to finish

2026-10-27

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically (histologically) proven diagnosis of prostate adenocarcinoma; prostatectomy must have been performed within 10 years prior to Step 1 registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
• Post-prostatectomy patients with a detectable serum PSA (>= 0.1, but =< 1.0 ng/mL) at study entry (within 90 days of Step 1 registration) and at least one of the following:
• Gleason score 7-10 (International Society of Urological Pathology [ISUP] grade group 2 to 5)
• ISUP grade group:
• Grade group 1 = Gleason score =< 6,
• Grade group 2 = Gleason score 3 + 4 = 7,
• Grade group 3 = Gleason score 4 + 3 = 7,
• Grade group 4 = Gleason score 8,
• Grade group 5 = Gleason scores 9 and 10
• >= T3a disease
• Persistent elevation of PSA after prostatectomy measured within 90 days after surgery (PSA never became undetectable) of > 0.04 but < 0.2 ng/mL (PSA nadir)
• pN0 or pNx
• History/physical examination within 90 days prior to Step 1 registration
• Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
• Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on Decipher GRID platform; Note: if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation and for GenomeDx to provide the subtyping needed for stratification
• Prior androgen deprivation therapy (luteinizing hormone-releasing hormone [LHRH] agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to Step 1 registration and given for =< 90 days duration
• For example: patients on prior LHRH analogs (post-prostatectomy), the discontinuation date should be calculated based on the expected duration of the sustained release injection, not simply the injection date of the drug; for instance, if a 22.5 mg sustained release dose of leuprolide acetate is given (3 month duration), then the expected duration of such a dose would be 90 days after the injection date; for a 7.5 mg leuprolide (1 month duration), the discontinuation date would be 30 days after the injection date
• Please note: finasteride or dutasteride must be stopped before treatment starts but prior usage will not affect eligibility
• Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to Step 1 registration
• Platelet count >= 100,000 x 10\^9/uL independent of transfusion and/or growth factors within 90 days prior to Step 1 registration
• Serum albumin >= 3.0 g/dL within 90 days prior to Step 1 registration
• Glomerular filtration rate (GFR) >= 35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to Step 1 registration
• Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (Note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible) within 90 days prior to Step 1 registration
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x ULN within 90 days prior to Step 1 registration
• Testosterone > 50 ng/dL within 90 days prior to Step 1 registration

You may not qualify if…

• PRIOR TO STEP 1 REGISTRATION:
• Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)
• Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• History of any of the following:
• Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to Step 1 registration)
• History of documented inflammatory bowel disease
• Transmural myocardial infarction within the last 4 months prior to Step 1 registration
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to Step 1 registration
• History of any condition that in the opinion of the investigator, would preclude participation in this study
• Current evidence of any of the following:
• Known gastrointestinal disorder affecting absorption of oral medications
• Active uncontrolled infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis)
• Uncontrolled hypertension
• Any current condition that in the opinion of the investigator, would preclude participation in this study
• Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound [HIFU]) for prostate cancer is not allowed
• HIV positive with CD4 count < 200 cells/microliter within 30 days prior to registration
• HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count; (Note: HIV testing is not required for eligibility for this protocol as it is self-reported; this exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive and/or interact with HAART)
• Patients must not plan to participate in any other clinical trials while receiving treatment on this study or being followed post-protocol therapy
• PRIOR TO STEP 2 REGISTRATION:
• 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

Where it is running

• Arizona Center for Cancer Care-Peoria — Peoria, Arizona, United States
• Arizona Center for Cancer Care - Scottsdale — Scottsdale, Arizona, United States
• Arizona Center for Cancer Care-Surprise — Surprise, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Marin General Hospital — Greenbrae, California, United States
• Los Angeles General Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Gene Upshaw Memorial Tahoe Forest Cancer Center — Truckee, California, United States
• Sutter Solano Medical Center/Cancer Center — Vallejo, California, United States
• UCHealth University of Colorado Hospital — Aurora, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• UCHealth Memorial Hospital Central — Colorado Springs, Colorado, United States
• Memorial Hospital North — Colorado Springs, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado, United States
• Valley View Hospital Cancer Center — Glenwood Springs, Colorado, United States
• UCHealth Greeley Hospital — Greeley, Colorado, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Stamford Hospital/Bennett Cancer Center — Stamford, Connecticut, United States
• Arizona Center for Cancer Care - Gilbert — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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