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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

Summary

Number

000569-C

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

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)

None

Intervention(s)

Drug: Apalutamide

Supporting Site

National Cancer Institute

Background:

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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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Peter A. Pinto, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 2-5952
10 CENTER DR
BETHESDA MD 20892
(240) 858-3700
pp173u@nih.gov

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
michele.reed@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04530552

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