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

• Status: Not yet recruiting
• Trial end date: 2029-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; Progenics Pharmaceuticals, Inc.

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 histologically confirmed prostate adenocarcinoma.

• 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 four weeks of the initial PSMA PET.

• 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 (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.