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Radiation Therapy with or without Apalutamide in Treating Patients with Stage III-IV Prostate Cancer

This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with stage III-IV prostate cancer. 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.
Not Available
Phase II
Adults
Not Available
Not Available
Kirschner, Austin
National
Vanderbilt University
10-22-2018
Treatment
NRGUROGU006
NCT03371719

Eligibility

18 Years
MALE
NO
Inclusion Criteria:

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 == T3a disease * Persistent elevation of PSA after prostatectomy measured within 90 days after surgery (PSA never became undetectable) of > 0.04 but
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

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 =
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 ULN, measure direct and indirect bilirubin and if direct bilirubin is =
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
Testosterone > 50 ng/dL within 90 days prior to Step 1 registration

Concomitant medications known to lower the seizure threshold discontinued or substituted at least 4 weeks (30 days) prior to Step 1 registration

The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug

The patient must agree not to donate sperm during the study treatment and for 3 months after receiving the last dose of study drug

The patient or a legally authorized representative must provide study-specific informed consent prior to study entry



Exclusion Criteria:

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
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

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

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