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Protocol Details

Clinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for Prostatectomy

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Androgen Receptor (Ar);
Gleason Score

Recruitment Keyword(s)



Prostate Cancer

Investigational Drug(s)


Investigational Device(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.


To test a new drug (apalutamide) in people with low-risk cancer that has not spread beyond the prostate gland.


People aged 18 years or older with prostate cancer who have been scheduled for surgery to remove the prostate gland.


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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-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.


-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.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Peter A. Pinto, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 2-5952
(240) 858-3700

Michele L. Reed, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room B2L324A
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6121

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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