Evaluating cognitive decline in men undergoing androgen deprivation therapy for prostate cancer

Plasma Amyloid-beta 42/40 to Predict Cognitive Decline From Androgen Deprivation Therapy in Prostate Cancer: a Prospective Observational Study

This study is testing if starting hormone therapy for prostate cancer affects thinking skills in men and whether changes in a specific blood marker are related to this decline.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of California, San Francisco (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT05820932 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the relationship between baseline plasma Amyloid-beta 42/40 ratio and cognitive decline in men starting androgen deprivation therapy (ADT) for prostate cancer. It will also investigate whether ADT is linked to changes in the plasma Aβ42/40 ratio and if intensified ADT leads to greater cognitive decline. Participants will undergo cognitive assessments and complete quality of life surveys, with a focus on understanding the implications of ADT on cognitive functioning. The study utilizes a blood-based assay for biomarkers, which is less invasive and more cost-effective than traditional methods.

Who should consider this trial

Good fit: Ideal candidates include men aged 18 or older with a diagnosis of prostate adenocarcinoma who are fluent in English and can complete study procedures online.

Not a fit: Patients who do not have prostate cancer or those with an ECOG performance status greater than 2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into predicting cognitive decline in prostate cancer patients undergoing ADT, potentially leading to improved patient management.

How similar studies have performed: Previous studies have indicated a potential link between ADT and cognitive impairment, suggesting that this approach may build on existing knowledge rather than being entirely novel.

Eligibility criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (RECRUITING)

Study contacts

• Principal investigator: Daniel Kwon, MD — University of California, San Francisco
• Study coordinator: UCSF Genitourinary Medical Oncology Recruitment

Conditions: Prostate Cancer, Cognitive decline, Cognitive functioning