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Evaluating PSMA Expression Changes in Prostate Cancer with Hormonal Therapy

This study is looking at how prostate-specific membrane antigen (PSMA) levels change in prostate cancer patients when they start hormonal therapy. PSMA is a protein found on prostate cancer cells. Researchers will use a special scan called a PSMA PET/CT or PSMA PET/MRI (Positron Emission Tomography/Computed Tomography or Magnetic Resonance Imaging) with a drug called Piflufolastat to measure these changes. The goal is to understand if these changes affect how doctors stage the cancer and to find the best time to do these scans after starting treatment. You could be eligible if you are an adult man (18 years or older) with confirmed prostate cancer, either Castration Sensitive Prostate Cancer (CSPC) or Castration Resistant Prostate Cancer (CRPC). The study aims to enroll 80 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, not randomized, that will divide 80 participants into two groups (CRPC or CSPC) to observe the effects of hormonal therapy.
What's involved
You would undergo PSMA PET scans before and after starting hormonal therapy (at 8 and 28 days), have blood samples collected, and your electronic health records reviewed. You will be followed for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years after starting hormonal therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05919329

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

Recruiting
PHASE4Ages 18+InterventionalDiagnostic
OHSU Knight Cancer Institute
~80 participants
Updated 2025-10-24 on ClinicalTrials.gov
What's tested:PiflufolastatPSMA PET/CT ScanPSMA PET/MRI scanBiospecimen CollectionElectronic Health Record Review

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in maximum standardized uptake value (SUVmax) on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline.
Measured over Baseline PSMA PET up to 8 days after therapy initiation

Conditions

Castration Resistant Prostate Cancer
Castration Sensitive Prostate Cancer
Prostate Adenocarcinoma

Explore related trials

Castration Resistant Prostate CancerCastration Sensitive Prostate CancerProstate Carcinoma

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Nadine Mallak, MD · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Lauren Drake
[email protected]
503-494-4960
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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, on continuous ADT at least 4 months, no AR targeted agent in the prior 4 months.
Cohort 2: Castration sensitive prostate cancer with no ADT or AR targeted agents use in the past 12 months, testosterone \>50 ng/dL

Exclusion

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.

What this trial measures

  • Change in maximum standardized uptake value (SUVmax) on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline.Baseline PSMA PET up to 8 days after therapy initiation

    Evaluate the change in SUVmax between baseline and Day 8 using a paired t-test to determine how hormonal therapy affects the PSMA modulation.