Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy

About This Trial

This study looks at how hormone therapy changes the way prostate cancer appears on specialized imaging scans, helping doctors find the best time to scan patients during treatment.
It is open to adult men with prostate cancer visible on these scans who are about to begin a new hormone treatment.
Patients can join whether their cancer is still responding to standard hormone therapy or has become resistant to it.
Before considering this trial, you should know that you will need to undergo imaging scans and cannot receive other cancer treatments, radiation, or herbal cancer supplements during your first month in the study.

This clinical trial investigates the change in prostate-specific membrane antigen (PSMA) expression in response to hormonal therapy in both, Castration Sensitive Prostate Cancer (CSPC) and Castration Resistant Prostate Cancer (CRPC), and whether this change in PSMA expression changes tumor staging after therapy initiation.
Understanding these effects can help define the best timing to perform the PSMA positron emission tomography (PET) relative to the start of therapy.

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study looks at how hormone therapy changes the way prostate cancer appears on specialized imaging scans, helping doctors find the best time to scan patients during treatment.

Full Eligibility Criteria

Inclusion Criteria

Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.
Participants must have confirmed prostate adenocarcinoma, histologically, or by combined imaging and biochemical markers.
Age >= 18 years. Given the nature of the disease in question, only men will be included. Members of all races and ethnic groups will be included.
Participants must have sites of prostate cancer showing uptake on an initial PSMA PET scan.
Participants are planned to receive hormonal therapy within eight weeks of the initial PSMA PET. The hormonal therapy agents include:
- For CSPC: GnRH agonists, GnRH antagonists, first-generation antiandrogen (e.g. bicalutamide), or androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)
- For CRPC: this group of patients are typically on continuous ADT (GnRH agonists or antagonists), which will be continued, and the hormonal therapy they will be started on is an androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)
Life expectancy > 3 months.
Cohort 1: Castration resistant prostate cancer with rising PSA (confirmed by two PSA values at least 1 week apart), testosterone 50 ng/dL

Exclusion Criteria

Uncontrolled serious infection.
Intercurrent illness or condition that would limit compliance with study requirements.
Participants who have undergone any cancer treatment other than the hormonal therapy (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the baseline PSMA PET and PSMA PET at day 28.