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โ† Trials
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An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial

RecruitingEARLY Phase 1Ages any - anyMaleNorthwestern University
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In plain words

What the trial is, and whether it could suit you

This phase II trial evaluates an imaging technique (rhPSMA-7.3 positron emission tomography \[PET\]/computed tomography \[CT\]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen negative on their most recent PET scan. Contrast agents like rhPSMA-7.3 (also called POSLUMA) circulate in the blood until they find their intended target. Once they are taken up by the target tumor cells, they can be visualized using PET/CT cameras. A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells often take up more tracer than normal cells, the pictures can be us

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy \[i.e. salvage radiation\]) * Men must have biochemical recurrence (defined as PSA \>= 0.1ng/ml) after therapy * PSA \< 0.5ng/ml (within 90 days of enrollment) * Men must have had negative or equivocal PET PSMA based imaging with 90 days of enrollment with an Food and Drug Administration (FDA) approved non-POSLUMA tracer * Non-castrate testosterone (testosterone \[T\] \> 50ng/dL) within 90 days of study entry * Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study * Concurrent diseases and malignancies are permitted Exclusion Criteria: * Most recent PSA not between 0.1ng/ml and 0.5ng/ml * Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T \< 50ng/dl) * Patients receiving 5-alpha reductase inhibitors, androgen deprivation therapy and androgen receptor antagonists within 3 months of enrollment (men may start these therapies at physician discretion immediately following POSLUMA PET PSMA scan)
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What it tests

  • Computed Tomography
  • Electronic Health Record Review
  • Flotufolastat F-18 Gallium
  • Positron Emission Tomography
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Where

1 site
Northwestern University
Chicago, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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