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

Description

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.

Conditions

Castration Resistant Prostate Cancer, Castration Sensitive Prostate Cancer, Prostate Adenocarcinoma

Study Overview

Study Details

Study 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.

Modulation of PSMA Expression in Castration Sensitive and Castration Resistant Prostate Cancer in Response to Hormonal Therapy

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

Condition
Castration Resistant Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Portland

OHSU Knight Cancer Institute, Portland, Oregon, United States, 97239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

OHSU Knight Cancer Institute,

Nadine Mallak, MD, PRINCIPAL_INVESTIGATOR, OHSU Knight Cancer Institute

Study Record Dates

2030-09-01