Clinical Trial Details
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NCT03016741 : Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer
PhasePhase 4
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Have pathologic diagnosis of prostate cancer and have received treatment with GnRH
agonist or antagonist therapy for at least 3 months prior to enrollment

- Willing and able to complete survey questionnaires in English with or without
assistance through the duration of the study

- Life expectancy >= 6 months

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Ability to understand and the willingness to sign a written informed consent document
written in English that is approved by an institutional review board


- Have castration-resistant metastatic disease (mCRPC) defined by the following:

- Castrate serum testosterone level =< 50 ng/dL (1.7 nmol/L)

- Bilateral orchiectomy or maintenance on androgen ablation therapy with GnRH
agonist or antagonist throughout the study (including the follow-up period)

- Serum prostate specific antigen (PSA) progression, defined as two consecutive
increases in PSA over a previous reference value within 6 months prior to
enrollment, with each progression measurement at least 1 week apart

- Willing and medically able to receive treatment with first-line AR directed therapy
with abiraterone acetate or enzalutamide as determined and prescribed by the primary

- Patients may have received the following prior AR directed therapy >= 24 months prior
to enrollment: bicalutamide, ketoconazole; prior to enrollment, patients may have
received treatment with abiraterone acetate or enzalutamide for no more than 7 days
before completing baseline studies

- Patients may have received chemotherapy for hormone-sensitive metastatic prostate
cancer only, but it must not have lasted for more than 6 months; at least 12 months
must have elapsed since completion of chemotherapy

- Patients may have received prior radiation therapy or surgery; however, at least 60
days must have elapsed since completion of radiation therapy or surgery and patient
must have only grade 2 or less adverse effects at the time of registration

- Patients must be able to take oral medication


- Control patients must be expected to stay on GnRH agonist or antagonist therapy for
high-risk localized, biochemical recurrent or hormone-sensitive metastatic prostate
cancer for the entire 12 months of the study; examples of eligible patients include
long-term androgen deprivation therapy (ADT) use after definitive external beam
radiation for high-risk localized prostate cancer, long-term ADT use after
prostatectomy for lymph node positive disease, long-term ADT use for biochemical
recurrence or elevated PSA post-prostatectomy, or long-term ADT use for hormone
sensitive metastatic prostate cancer; control patients should not expect to receive
additional treatments for their prostate cancer during the 12 months of the study,
including but not limited to additional salvage or adjuvant radiation, surgery,
chemotherapy, or other intervention; if these interventions are expected, enrollment
should be delayed until after the intervention; unexpected changes in treatment,
including the use of medications for mCRPC, are completely acceptable and at the
discretion of the treating physician; questions regarding the eligibility of control
patients should be directed to the principal investigator (PI)

Exclusion Criteria:

- Prior treatment with enzalutamide or abiraterone acetate for > 7 days prior to
enrollment and completion of baseline tests

- Receipt of chemotherapy for prostate or other cancer within the past 12 months with
residual cognitive deficits, or receipt of chemotherapy for mCRPC; patients/physicians
planning treatment with chemotherapy during the 12 month period of the investigation
are also ineligible

- History of cognitive impairment or dysfunction, including a history of dementia,
Alzheimer's disease, stroke with residual cognitive deficits, cognitive dysfunction
related to alcohol or substance abuse, or cognitive dysfunction related to prior
treatment for any cancer

- Patients with a seizure history, history of recurrent falls, or known brain metastases
are excluded from this clinical trial because of their poor prognosis and because of
their heightened risk of seizure or progressive cognitive and/or neurologic
dysfunction that would confound the evaluation

- Uncontrolled intercurrent illness including, but not limited to, uncontrolled
diabetes, ongoing or active infection, symptomatic congestive heart failure (New York
Heart Association class III and IV heart failure), unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations/substance abuse that would limit
compliance with study requirements

- Patients with a "currently active" second malignancy other than non-melanoma skin
cancers are not eligible; patients are not considered to have a "currently active"
malignancy if they have completed all therapy and are now considered without evidence
of disease for 1 year; patients with cognitive dysfunction related to treatment of
another malignancy, including a history of "chemo-brain", are ineligible

- Patients taking psychotropic medications or illicit drugs that may alter cognition,
concentration, or behavior; appropriate treatment by a licensed provider with
medications for depression or anxiety, including but not limited to selective
serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors
(SNRIs), and standard dose benzodiazepines at a stable dose, is permitted

- Control patients cannot have a diagnosis of mCRPC
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