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Fast Facts
NCI Protocol # UAZ20-01-01
Clinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for Prostatectomy
Study Information:
- A new prostate cancer research study is being conducted at the University and sponsored by the National Cancer Institute.
- The study is recruiting men diagnosed with prostate cancer and scheduled for removal of the prostate gland.
- The purpose is to determine whether apalutamide will lead to lowered PSA levels in men with prostate cancer confined to the prostate gland.
- Apalutamide is an FDA approved oral medication used to treat prostate cancer patients with advanced stages of the disease.
- The study will use low doses of apalutamide (one-quarter or less than the dose used in patients with advanced stages of prostate cancer).
- This study may help researchers learn more about how apalutamide works in the body and how it may be used to help prevent prostate cancer from worsening.
Study Involvement:
- Come to a study clinic to undergo a screening process to determine eligibility for study participation - brief physical exam, review of medical history and current medications, blood tests, study questionnaires
- Once determined eligible, take Apalutamide as prescribed until the day of the scheduled prostate surgery.
- Weekly communication with the study staff
- Return to the study clinic within 3 days before surgery - brief physical exam, additional blood tests, study questionnaires
- Final study visit 7-14 days after the prostate surgery for additional blood tests - may be combined with the post-op appointment.
Subject Compensation:
Qualified participants receive apalutamide and study evaluations at no cost and up to $300 for participation
Study Coordinator:
Frances Epstein, 520-471-7867 fminter@arizona.edu
Primary Objective:
To determine the effects of low dose apalutamide on circulating levels of Prostate Specific Antigen (PSA).
Secondary Objectives:
- Reversibility of testosterone levels 7-14 days post intervention
- Post-intervention plasma trough apalutamide concentration
- Intra-prostatic immune cell infiltration
- Health-related quality of life
- Gleason score of pre- and post-intervention tumor(s) with matched location
Inclusion Criteria
- Men over the age of 18 with histologically confirmed organ-confined adenocarcinoma of the prostate (PCa) suitable for prostatectomy.
- Gleason score ≤ (4+4).
- Current serum PSA < 10 ng/ml OR PSA ≥ 10 ng/ml with PSA density < 0.3ng/ml2.
- Karnofsky ≥70%.
- Participants must have normal organ and marrow function.
- TSH within the institutional normal range.
- Willing to use adequate contraception for the duration of study participation and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Prior or ongoing hormonal treatment for prostate cancer.
- Patients who have prostate cancer with distant metastases.
- Presence of neuroendocrine differentiation in the prostate biopsies.
- Serum testosterone (blood collected between 7-10 AM) < 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 or clinically significant ventricular arrhythmias within 6 months prior to registration.
- History of seizure or known condition that may pre-dispose to seizure.
- Use of drugs known to lower the seizure threshold.
- Concurrent use of drugs in category X.
- 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.
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