Actively Recruiting
Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
Led by OHSU Knight Cancer Institute · Updated on 2025-10-24
80
Participants Needed
1
Research Sites
322 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative must provide written informed consent before any study-specific procedures or interventions.
- Confirmed prostate adenocarcinoma by histology or combined imaging and biochemical markers.
- Male participants aged 18 years or older from all races and ethnic groups.
- Presence of prostate cancer sites showing uptake on an initial PSMA PET scan.
- Planned to receive hormonal therapy within eight weeks of the initial PSMA PET.
- For CSPC: use of GnRH agonists, GnRH antagonists, first-generation antiandrogens, or androgen receptor-targeted agents.
- For CRPC: continuous ADT for at least 4 months, rising PSA confirmed by two values at least one week apart, testosterone below 50 ng/dL, no AR-targeted agent in prior 4 months.
- For CSPC: no ADT or AR-targeted agents use in the past 12 months, testosterone above 50 ng/dL.
- Life expectancy greater than 3 months.
You will not qualify if you...
- Uncontrolled serious infection.
- Any illness or condition that would limit compliance with study requirements.
- Any cancer treatment other than hormonal therapy (systemic or radiation) started between baseline PSMA PET and day 28 PSMA PET.
- Use of supplements or herbal medications intended to treat cancer started between baseline PSMA PET and day 28 PSMA PET.
AI-Screening
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
L
Lauren Drake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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