Study Comparing Urinary Radioactivity in Men with Low PSA Recurrence of Prostate Cancer After Surgery Using Two PET Scans

Sponsor: Blue Earth Diagnostics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06604442

Provider View

This clinical trial is examining the differences in urinary radioactivity between two types of PET scans, Piflufolastat (18F) and Flotufolastat (18F), in men who have a low PSA recurrence of prostate cancer after surgery.

Patient Parameters

Program Overview

The study aims to compare the levels of radioactivity in urine after using two different PET scans, Piflufolastat (18F) and Flotufolastat (18F), in men who have experienced a low PSA recurrence of prostate cancer following surgery. This research will help understand how these scans perform in detecting cancer recurrence when PSA levels are low.

Description

This study involves men who have had prostate cancer surgery and now show a low level of PSA, indicating a possible recurrence of cancer. Researchers will use two different PET scans, Piflufolastat (18F) and Flotufolastat (18F), to measure radioactivity in the urine. This will help determine how effective each scan is in detecting cancer recurrence. Participants will undergo both scans, and the results will be compared to see which scan provides better information.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Have a history of prostate cancer treated with surgery, with PSA levels initially undetectable after surgery.
  • Experiencing a recurrence of prostate cancer with low PSA levels (0.5 ng/mL or less).
  • At least 6 months have passed since surgery.
  • Scheduled to have a PSMA PET scan by their doctor.
  • Able to understand and sign a consent form and follow study requirements.

Exclusion Criteria

  • Any medical condition that might affect the study results or the participant's ability to complete the study.
  • Planned to have an x-ray contrast or another PET scan within 24 hours before the study scans.
  • Already had a Piflufolastat (18F) PET scan before joining the study.
  • Participating in another clinical trial within the last 30 days or received certain treatments recently.
  • Allergic to the substances used in the PET scans.
  • Have had bladder removal surgery, kidney failure, or other conditions affecting urine output.
  • Have already received additional cancer treatment after surgery.

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