This study is NOT currently recruiting participants.
Number
000569-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Female;Children
Keywords
Surveillance; Androgen Receptor (Ar); Inhibitor; PSA; Gleason Score
Recruitment Keyword(s)
None
Condition(s)
Prostate Cancer
Investigational Drug(s)
Apalutamide
Investigational Device(s)
Intervention(s)
Drug: Apalutamide
Supporting Site
National Cancer Institute
Prostate cancer is often treated with surgery or radiation. These approaches can cause serious side effects, and men with certain low-risk prostate cancers may be overtreated. A new drug may be able to slow the progress of these low-risk cancers.
Objective:
To test a new drug (apalutamide) in people with low-risk cancer that has not spread beyond the prostate gland.
Eligibility:
People aged 18 years or older with prostate cancer who have been scheduled for surgery to remove the prostate gland.
Design:
Participants will be screened. They will have a physical exam with blood tests. Their existing images and biopsy specimens will be reviewed. They will answer questions about their use of alcohol and tobacco.
Apalutamide is a tablet participants will take by mouth. They will receive a supply of the pills and be instructed to take them for up to 8 weeks before their scheduled surgery. They may take the drug for up to 12 weeks if surgery is delayed.
Participants will use a calendar to keep track of when they take their pills; they will also record any side effects in a diary.
Participants will be contacted every 7 to 10 days while they are taking the drug.
Participants will visit the clinic within 3 days before their surgery. They will have a physical exam and blood tests. They will answer questions about their quality of life and their use of alcohol and tobacco.
Participants will have a follow-up visit 7 to 14 days after their prostate surgery.
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INCLUSION CRITERIA: -Histologically confirmed organ-confined adenocarcinoma of the prostate (PCa) suitable for prostatectomy. -Gleason score <= (4+4), however no Gleason pattern 5. -Current serum PSA <= 20 ng/ml. -Age >18 years. -Karnofsky >=70% -Participants must meet the following laboratory measures: --Leukocytes >=3,000/microL --Absolute neutrophil count >=1,500/microL --Platelets >=100,000/microL --Total bilirubin <=1.5 X institutional 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 may be eligible) --AST (SGOT)/ALT (SGPT) <2.5 X institutional ULN --Creatinine <2 X institutional ULN -TSH within the institutional normal range. -Willing to use adequate contraception (barrier method; abstinence; subject has had a vasectomy; or partner is using effective birth control or is postmenopausal) for the duration of study participation. -Ability to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: -Prior or ongoing hormonal treatment for prostate cancer including, but not limited to orchiectomy, antiandrogens, abiraterone, ketoconazole, or estrogens, or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists. Men on stable doses of 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) are eligible as long as there is no planned dose change while on study. -Patients who have prostate cancer with distant metastases. -Presence of neuroendocrine differentiation in the prostate biopsies. -Serum testosterone (blood collected between 7-10 AM for men < 45 years of age and prior to 2 PM for men >= 45 years of age) < 200 ng/dL. -Have a history of prior malignancies other than prostate cancer within the past 2 years, excluding non-melanoma skin cancer. -Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration. -History of seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to registration, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect). -Use of drugs known to lower the seizure threshold, including: atypical antipsychotics (e.g. clozapine, olanzapine, risperidone, ziprasidone), bupropion, lithium, meperidine, pethidine, phenothiazine antipsychotics (e.g. chlorpromazine, mesoridazine, thioridazine), and tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine). -Concurrent use of drugs in category X drug interactions with apalutamide. -Participants may not be receiving any other investigational agents. -History of allergic reactions attributed to compounds of similar chemical composition of apalutamide. -Uncontrolled intermittent illnesses or medical conditions which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. Such illnesses/conditions may include, but are not limited to, hypertension, ongoing or active infection, or psychiatric illness/social situations.
-Histologically confirmed organ-confined adenocarcinoma of the prostate (PCa) suitable for prostatectomy.
-Gleason score <= (4+4), however no Gleason pattern 5.
-Current serum PSA <= 20 ng/ml.
-Age >18 years.
-Karnofsky >=70%
-Participants must meet the following laboratory measures:
--Leukocytes >=3,000/microL
--Absolute neutrophil count >=1,500/microL
--Platelets >=100,000/microL
--Total bilirubin <=1.5 X institutional 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 may be eligible)
--AST (SGOT)/ALT (SGPT) <2.5 X institutional ULN
--Creatinine <2 X institutional ULN
-TSH within the institutional normal range.
-Willing to use adequate contraception (barrier method; abstinence; subject has had a vasectomy; or partner is using effective birth control or is postmenopausal) for the duration of study participation.
-Ability to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
-Prior or ongoing hormonal treatment for prostate cancer including, but not limited to orchiectomy, antiandrogens, abiraterone, ketoconazole, or estrogens, or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists. Men on stable doses of 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) are eligible as long as there is no planned dose change while on study.
-Patients who have prostate cancer with distant metastases.
-Presence of neuroendocrine differentiation in the prostate biopsies.
-Serum testosterone (blood collected between 7-10 AM for men < 45 years of age and prior to 2 PM for men >= 45 years of age) < 200 ng/dL.
-Have a history of prior malignancies other than prostate cancer within the past 2 years, excluding non-melanoma skin cancer.
-Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration.
-History of seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to registration, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect).
-Use of drugs known to lower the seizure threshold, including: atypical antipsychotics (e.g. clozapine, olanzapine, risperidone, ziprasidone), bupropion, lithium, meperidine, pethidine, phenothiazine antipsychotics (e.g. chlorpromazine, mesoridazine, thioridazine), and tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
-Concurrent use of drugs in category X drug interactions with apalutamide.
-Participants may not be receiving any other investigational agents.
-History of allergic reactions attributed to compounds of similar chemical composition of apalutamide.
-Uncontrolled intermittent illnesses or medical conditions which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. Such illnesses/conditions may include, but are not limited to, hypertension, ongoing or active infection, or psychiatric illness/social situations.
Principal Investigator
Referral Contact
For more information: