Condition: Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, Castrate Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer, Non-metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04335682

Sponsor: Alliance Foundation Trials, LLC.

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

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.

View trial on ClinicalTrials.gov