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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Piflufolastat
  • PSMA PET/CT Scan
  • PSMA PET/MRI scan
  • Biospecimen Collection
  • Electronic Health Record Review

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator

Progenics Pharmaceuticals, Inc.

Collaborator