Predicting Cognitive Decline From Androgen Deprivation Therapy

Open to males ages 18 years and up

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.

Patient Participants-

• Small cell prostate carcinoma (pure or mixed).
• 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.
• Testosterone <100 ng/ml.
• Prior or concurrent brain metastases (no prior or screening imaging is required).
• Major neurocognitive or psychiatric disorders, such as dementia or schizophrenia.
• Prior or concurrent malignancy other than prostate cancer whose natural history or treatment has the potential to interfere with study assessments.

Study partner participants-

• None.

Only the ADT cohort-

• None.

Only the PC cohort-

• 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.