Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

This is a prospective, randomized, open-label phase II study comparing cognitive outcomes between men with metastatic and non-metastatic castration resistant prostate cancer (CRPC) or metastatic hormone sensitive prostate cancer (HSPC). Approximately 132 patients will be enrolled. Eligible patients will be randomized in a 1:1 fashion to treatment with enzalutamide 160 mg orally daily or darolutamide 600 mg orally twice daily, in combination with standard LHRH agonist based treatment. Cognitive assessments will be performed using modules from Cambridge Neuropsychological Test Automated Battery (CANTAB) an internationally recognized software for assessing cognitive function and impairment.

Official Title

A Randomized Phase II Study of Androgen Receptor Directed Therapy on COGnitive Function in Patients Treated With Darolutamide or Enzalutamide (ARACOG)

Details

The goal of the trial is to assess cognitive and quality of life outcomes over the 48-week primary data collection period of the trial. This is a prospective, randomized, open-label phase II study comparing cognitive outcomes between men with Advanced prostate cancer: metastatic and non-metastatic castration resistant prostate cancer (CRPC) or metastatic hormone sensitive prostate cancer (HSPC).

The primary endpoint will be the percent change in the maximally changed cognitive domain by 24 weeks in each study arm. Patients will be stratified by age (<65, 65-80, > 80). Patients will be allowed to cross over from either treatment to the opposite treatment arm at 12 and 24 weeks if they meet any of the cross-over criteria as described in the protocol.

Cognitive assessments will be performed using Cambridge Neuropsychological Test Automated Battery (CANTAB), an internationally recognized software for assessing cognitive function and impairment. Tests available in the CANTAB battery include tests of learning and executive function; working memory; visual, verbal and episodic memory; and attention, information and processing time. The maximally changed cognitive domain is defined as the domain most changed from baseline in each individual.

Blood samples will be collected for exploratory genomic analyses (AR CAG repeat length, PHS, exosome analysis).

Patients will have the option to opt into an additional separate MRI sub-study. A subset of 40 patients (20 per arm) will undergo fMRI to measure percent signal change in the HP PFC circuit at baseline, 24 and 48 weeks or/and cross-over/end of treatment visit (if applicable).

Keywords

Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, Castrate Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer, Non-metastatic Prostate Cancer, Prostatic Neoplasms, Darolutamide, Enzalutamide, Darolutamide (DARO), Enzalutamide (ENZ)

Eligibility

For males ages 18 years and up

Key inclusion criteria include:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Progressive disease per PCWG3 criteria with EITHER: Metastatic CRPC or non-metastatic CRPC (M0CRPC)
    • For mCRPC: metastatic disease documented by standard or novel imaging techniques
    • OR for M0CPRC: no evidence of metastatic disease on standard imaging.
  • OR mHSPC
  • Surgically or medically castrated, with testosterone levels of <50 ng/dL. If the patient is medically castrated, continuous dosing with GnRH agonist or antagonist must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Able to complete cognitive testing and patient reported outcome surveys in English.
  • Ability to swallow study medications whole.
  • Able to provide informed consent.

Locations

  • UCSF at Mount Zion accepting new patients
    San Francisco California 94115 United States
  • University of Oklahoma terminated
    Oklahoma City Oklahoma 73104 United States
  • University of Minnesota accepting new patients
    Minneapolis Minnesota 55455 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance Foundation Trials, LLC.
ID
NCT04335682
Phase
Phase 2 Prostate Cancer Research Study
Study Type
Interventional
Participants
Expecting 132 study participants
Last Updated