Predicting Cognitive Decline From Androgen Deprivation Therapy

Ki vehet részt

• Patient Participants-
• Age 18 years or greater
• Fluent in reading, listening to, and writing English
• Current or prior diagnosis of prostate adenocarcinoma based on a pathology report or as documented in a medical oncology, urology, or radiation oncology note
• Access and ability to use a computer or mobile device with Internet connectivity to complete study procedures
• Telephone Montreal Cognitive Assessment (T-MoCA) of 16 or greater
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (documented within past 3 months, otherwise patient-reported); Study partner participants-
• Age 18 years or greater
• Fluent in reading, listening to, and writing English
• Identified by patient participant as a person who knows patient participant well, like a friend, family member or spouse
• Access and ability to use a computer or mobile device with internet connectivity to complete study procedures; Only the ADT cohort-
• Anticipated to start ADT, which includes one of the following two treatments; Gonadotropin-releasing hormone (GnRH) agonist (e.g., leuprolide, goserelin, and others); GnRH antagonist (i.e., degarelix or relugolix)
• Anticipated to remain on ADT for at least 12 months
• Concurrent first-generation anti-androgens (e.g., bicalutamide, flutamide, nilutamide) and novel androgen-signaling inhibitors (e.g., abiraterone, enzalutamide, and apalutamide) are allowed
• Concurrent radiation is allowed; Only the PC cohort-
• Has completed definitive local therapy (radical prostatectomy or radiation therapy) for localized prostate cancer at least 6 months prior to screening
• For radical prostatectomy: undetectable prostate-specific antigen (PSA) within 12 months of screening
• For radiation therapy: last PSA of < 2.0 within 12 months of screening

Ki nem vehet részt

• Receipt of ADT (GnRH agonist, GnRH antagonist, 1st-generation anti-androgen, or novel androgen signaling inhibitor) within 6 months before screening. ADT >6 months prior to screening is allowed provided testosterone has recovered to 100 ng/ml or greater
• Concurrent or anticipated (at any point during first 12 months of ADT) non-hormonal, antineoplastic systemic therapy, such as chemotherapy
• Prior or concurrent brain metastases (no prior or screening imaging is required)
• Prior or concurrent malignancy other than prostate cancer whose natural history or treatment has the potential to interfere with study assessments; Study partner participants-
• Any prior, concurrent, or anticipated use of any hormonal systemic therapy, including GnRH agonist, GnRH antagonist, 1st-generation anti-androgen, or novel androgen signaling inhibitor
• Any known or prior history of M1 prostate cancer (no screening imaging required)
• Current or prior biochemical recurrence following American Urological Association guidelines for radical prostatectomy or American Society for Therapeutic Radiology and Oncology (ASTRO) guidelines for radiation therapy
• Major neurocognitive or psychiatric disorders, such as dementia or schizophrenia
• Patient Participants-
• Small cell prostate carcinoma (pure or mixed)
• Testosterone <100 ng/ml
• None; Only the ADT cohort-
• None; Only the PC cohort-