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

StatusRecruiting
PhasePhase 4
Started

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Record History

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  1. Interventions: Biospecimen Collection (Procedure), Electronic Health Record Review (Other), PSMA PET/CT Scan (Procedure), PSMA PET/MRI scan (Procedure)… to Biospecimen Collection (Procedure), Electronic Health Record Review (Other), PSMA PET/CT Scan (Procedure), PSMA PET/MRI scan (Procedure)…
    • Eligibility criteria expanded, about 13 words
  2. Re-verified, no change to tracked fieldsv7
  3. Eligibility criteria expanded, about 7 wordsv6
  4. Study completion date: Sep 1, 2029 to Sep 1, 2030
    • Eligibility criteria expanded, about 64 words
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2024 to Jun 25, 2024
    • Site details revised
    • Eligibility criteria expanded, about 5 words
    v4
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  1. Start date: Jan 1, 2024 to May 1, 2024v3
  2. Start date: Aug 1, 2023 to Jan 1, 2024v2 Show 6 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 60 to 80
    • Interventions: Biospecimen Collection (Procedure), Electronic Health Record Review (Other), Piflufolastat (Drug), Positron Emission Tomography/Computed… to Biospecimen Collection (Procedure), Electronic Health Record Review (Other), PSMA PET/CT Scan (Procedure), PSMA PET/MRI scan (Procedure)…
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 8 words
    • Collaborators revised (2)
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05919329
Lead Sponsor OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University, Progenics Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Castration Resistant Prostate Cancer, Castration Sensitive Prostate Cancer, Prostate Adenocarcinoma
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov