Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland

  • End date
    Jan 31, 2024
  • participants needed
  • sponsor
    National Cancer Institute (NCI)
Updated on 7 October 2022


This phase IIa trial investigates how well apalutamide before surgery works in treating patients with prostate cancer that is confined to the prostate gland. Testosterone can cause the growth of prostate cancer cells. Apalutamide blocks the use of testosterone by the tumor cells. Giving low dose apalutamide before prostate surgery may lead to lowered PSA levels in men with prostate cancer that is confined to the prostate gland.



I. To determine the effects of low dose apalutamide on circulating levels of prostate specific antigen (PSA).


I. To determine the effect of low dose apalutamide on:

Ia. Reversibility of testosterone levels 7-14 days post intervention. Ib. Post-intervention plasma trough apalutamide concentration. Ic. Health-related quality of life.


I. To determine the effects of apalutamide on intra-prostatic immune cell infiltration and Gleason score and the effects of tobacco/alcohol use on the study endpoints.


The first 40 patients taking part in this trial receive apalutamide orally (PO) three times a week (TIW) for 4-8 weeks prior to before prostate surgery in the absence of disease progression or unacceptable toxicity. Based on PSA levels of the first 40 patients, the next group of 40 patients receive apalutamide either once a week (QW) or once daily (QD) for 4-8 weeks prior to before prostate surgery in the absence of disease progression or unacceptable toxicity. Patients may receive apalutamide for up to 4 to 12 weeks before prostate surgery (in the event surgery is delayed).

After completion of study treatment, patients are followed up at 7-14 days after prostate surgery.

Condition Localized Prostate Carcinoma, Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8
Treatment quality-of-life assessment, Apalutamide
Clinical Study IdentifierNCT04530552
SponsorNational Cancer Institute (NCI)
Last Modified on7 October 2022


Yes No Not Sure

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
Karnofsky >= 70%
Age > 18 years
Leukocytes >= 3,000/uL
Absolute neutrophil count >= 1,500/uL
Platelets >= 100,000/uL
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)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 2.5 x institutional ULN
Creatinine < 2 x institutional ULN
Thyroid stimulating hormone (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
Have a history of prior malignancies other than prostate cancer within the past 2 years, excluding non-melanoma skin cancer
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
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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