RECRUITING

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

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Conditions

Castration Resistant Prostate CancerCastration Sensitive Prostate CancerProstate Adenocarcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-25
Study Completion:2030-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05919329

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.
  2. * Participants must have histologically confirmed prostate adenocarcinoma.
  3. * 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.
  4. * Participants must have sites of prostate cancer showing uptake on an initial PSMA PET scan.
  5. * Participants are planned to receive hormonal therapy within eight weeks of the initial PSMA PET. The hormonal therapy agents include:
  6. * For CSPC: GnRH agonists, GnRH antagonists, first-generation antiandrogen (e.g. bicalutamide), or androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)
  7. * 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)
  8. * Life expectancy \> 3 months.
  9. * 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.
  10. * Cohort 2: Castration sensitive prostate cancer with no ADT or AR targeted agents use in the past 12 months, testosterone \>50 ng/dL
  1. * Uncontrolled serious infection.
  2. * Intercurrent illness or condition that would limit compliance with study requirements.
  3. * 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.

Contacts and Locations

Study Contact

Lauren Drake
CONTACT
503-494-4960
RADResearch@ohsu.edu

Principal Investigator

Nadine Mallak, MD
PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute

Study Locations (Sites)

OHSU Knight Cancer Institute
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: OHSU Knight Cancer Institute

  • Nadine Mallak, MD, PRINCIPAL_INVESTIGATOR, OHSU Knight Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-25
Study Completion Date2030-09-01

Study Record Updates

Study Start Date2024-06-25
Study Completion Date2030-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Castration Resistant Prostate Cancer
  • Castration Sensitive Prostate Cancer
  • Prostate Adenocarcinoma