Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
Modulation of PSMA Expression in Castration Sensitive and Castration Resistant Prostate Cancer in Response to Hormonal Therapy
2 other identifiers
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2024
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedStudy Start
First participant enrolled
June 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
October 24, 2025
October 1, 2025
4.2 years
June 16, 2023
October 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in maximum standardized uptake value (SUVmax) on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline.
Evaluate the change in SUVmax between baseline and Day 8 using a paired t-test to determine how hormonal therapy affects the PSMA modulation.
Baseline PSMA PET up to 8 days after therapy initiation
Secondary Outcomes (2)
Change in SUVmax on post-therapy initiation PSMA PET (28 ± 3 days) compared to baseline.
Baseline PSMA PET up to 28 days after therapy initiation
Number of patients in whom the tumor staging changed on PSMA PET scans obtained post-therapy initiation relative to baseline PET scan
Baseline PSMA PET up to 28 days after therapy initiation
Study Arms (2)
Cohort 1: CRPC
EXPERIMENTALPatients with CRPC will receive 18F-DCFPyL PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy.
Cohort 2: CSPC
EXPERIMENTALPatients with CSPC will receive 18F-DCFPyL PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy.
Interventions
Given IV
Undergo PSMA PET/CT
Undergo PET/MRI
Undergo collection of blood samples
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OHSU Knight Cancer Institutelead
- Oregon Health and Science Universitycollaborator
- Progenics Pharmaceuticals, Inc.collaborator
Study Sites (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadine Mallak, MD
OHSU Knight Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 16, 2023
First Posted
June 26, 2023
Study Start
June 25, 2024
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2030
Last Updated
October 24, 2025
Record last verified: 2025-10