TheranosticTrials.org

Clinical Trial · NCT05919329

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

Overview

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.

Sponsor

OHSU Knight Cancer Institute

Phase

Phase 4

Contacts

Nadine Mallak, MD (PRINCIPAL_INVESTIGATOR)

Lauren Drake (CONTACT)

radresearch@ohsu.edu

503-494-4960

ClinicalTrials.gov

NCT05919329

Drug / Compound

DCFPyL

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Life expectancy \> 3 months.
  • Cohort 2: Castration sensitive prostate cancer with no ADT or AR targeted agents use in the past 12 months, testosterone \>50 ng/dL
  • Participants must have confirmed prostate adenocarcinoma, histologically, or by combined imaging and biochemical markers.
  • Participants must have sites of prostate cancer showing uptake on an initial PSMA PET scan.
  • For CSPC: GnRH agonists, GnRH antagonists, first-generation antiandrogen (e.g. bicalutamide), or androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)
  • Participants are planned to receive hormonal therapy within eight weeks of the initial PSMA PET. The hormonal therapy agents include:
  • 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.
  • 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)

Exclusion

  • 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.
  • Uncontrolled serious infection.
  • Intercurrent illness or condition that would limit compliance with study requirements.