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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT05919329
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Piflufolastat — DRUG
    Given IV
  • PSMA PET/CT Scan — PROCEDURE
    Undergo PSMA PET/CT
  • PSMA PET/MRI scan — PROCEDURE
    Undergo PET/MRI
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Electronic Health Record Review — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jun 25, 2024
Status verified
Oct 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort 1: CRPC
    Patients with CRPC will receive 18F-DCFPyL PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy.
  • Experimental: Cohort 2: CSPC
    Patients with CSPC will receive 18F-DCFPyL PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy.

Primary Outcome Measure

Change in maximum standardized uptake value (SUVmax) on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline. [ Time Frame: Baseline PSMA PET up to 8 days after therapy initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Lauren Drake
[email protected]
503-494-4960
Nadine Mallak, MD (PRINCIPAL_INVESTIGATOR)

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OHSU Knight Cancer Institute· Portland, OR

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