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

NCT05919329 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-10-24

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Piflufolastat

Given IV

PROCEDURE

PSMA PET/CT Scan

Undergo PSMA PET/CT

PROCEDURE

PSMA PET/MRI scan

Undergo PET/MRI

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

OTHER

Electronic Health Record Review

Ancillary studies

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • Progenics Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Nadine Mallak, MD · OHSU Knight Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2028-09-01
Completion
2030-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919329 on ClinicalTrials.gov