NCT05919329 Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
| NCT ID | NCT05919329 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | OHSU Knight Cancer Institute |
| Condition | Castration Resistant Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2024-06-25 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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, 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 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.
Contact & Investigator
Nadine Mallak, MD
PRINCIPAL INVESTIGATOR
OHSU Knight Cancer Institute
Frequently Asked Questions
Who can join the NCT05919329 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Castration Resistant Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05919329 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05919329 currently recruiting?
Yes, NCT05919329 is actively recruiting participants. Contact the research team at RADResearch@ohsu.edu for enrollment information.
Where is the NCT05919329 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT05919329 clinical trial?
NCT05919329 is sponsored by OHSU Knight Cancer Institute. The principal investigator is Nadine Mallak, MD at OHSU Knight Cancer Institute. The trial plans to enroll 80 participants.
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