Trial Search Results

Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Progenics Pharmaceuticals, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: 18F-DCFPyL

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Male >/= 18 years of age

   - Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with
   subsequent definitive therapy

   - Suspected recurrence of prostate cancer based on rising PSA after definitive therapy
   on the basis of:

      1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a
      confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or

      2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that
      is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic
      Radiology and Oncology [ASTRO]-Phoenix)

   - Negative or equivocal findings for prostate cancer on conventional imaging performed
   as part of standard of care workup within 60 days prior to Day 1

   - Life expectancy ≥6 months as determined by the investigator

   - Able and willing to provide informed consent and comply with protocol requirements

Exclusion Criteria:

   - Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within
   five (5) physical half-lives prior to Day 1

   - Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH
   agonist or antagonist) for prostate cancer

   - Treatment with ADT in the past 3 months of Day 1

   - Receipt of investigational therapy for prostate cancer within 60 days of Day 1

   - Subjects with any medical condition or other circumstances that, in the opinion of the
   investigator, compromise the safety or compliance of the subject to produce reliable
   data or completing the study

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shahryar Niknam
408-721-4080
Recruiting