Fluorine-18 - 2-(3-(1-carboxy-5-[(6-[18F]Fluoro-pyridine-3-carbonyl)-Amino]-Pentyl)-Ureido)-Pentanedioic Acid (18F-DCFPyL) Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of Recurrent Prostate Cancer


Condition: Prostatic Neoplasms, Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02899312

Sponsor: British Columbia Cancer Agency

Phase:

Eligibility:

  • Age: minimum 19 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Known PC with a biochemical recurrence (BR) after initial curative therapy with radical prostatectomy, with a documented history of failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increased on 2 or more determinations (PSA recurrence). The patient may have received treatment following documentation of PSA persistence or PSA recurrence. The most recent PSA measurement must be greater than 0.4 ng/mL.
  • Participants with findings on other examinations (such as plain x-ray, CT, MRI or bone scintigraphy and others) that are suspicious for metastatic disease but not conclusively diagnostic of metastatic disease.
  • Known PC with BR after initial curative therapy with radiation therapy (including brachytherapy), with a PSA level >2 ng/mL above the nadir after radiation therapy.
  • Castration resistant PC with a minimum PSA of 2.0 ng/mL with 2 consecutive rises above the nadir and castrate levels of testosterone (<1.7 nmol/L). Treatment does not need to be discontinued before the 18F-DCFPyL scan.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.

Exclusion Criteria:

  • Medically unstable (eg. acute illness, unstable vital signs)
  • Unable to lie supine for the duration of imaging
  • Unable to provide written consent
  • Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)

View trial on ClinicalTrials.gov


email news signup