Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Washington

About this trial

This phase II trial studies how well prostate specific membrane antigen (PSMA) or fluciclovine positron emission tomography (PET)/computed tomography (CT) site-directed therapy works for treating patients with prostate cancer. PSMA or fluciclovine PET/CT may detect prostate cancer early and may help to show whether patients benefit from site directed treatment to PET detected abnormalities.

Eligibility criteria

Qualifiers

Patient must have histologically or cytologically documented evidence of prostate adenocarcinoma

Patient must previously have undergone radical prostatectomy

Patient must previously have undergone either adjuvant or salvage radiation therapy to the prostatic fossa +/- whole pelvis

Patient must have a prostate specific antigen (PSA) >= 0.2 and < 10 ng/mL. If there is only one PSA value that has risen to >= 0.2 with this biochemical recurrence, a second PSA value must be confirmed to be within >= 0.2 and < 10 ng/mL at least 2 weeks from the first value and within 28 days of enrollment

Disqualifiers

Chronic active hepatitis B or C

History of a second, non-prostate malignancy that required systemic therapy in the last 2 years except cancer in situ of bladder and non-melanomatous cancers of the skin

Patient with a serious underlying medical condition that would otherwise impair the patient's ability to undergo fluciclovine or PSMA PET/CT imaging or receive subsequent treatment

Any condition that would alter the patient's mental status, prohibiting understanding and/or authorization of informed consent

Trial design

Treatments tested in this trial

  • Positron Emission Tomography
  • Lymphadenectomy
  • Radiation Therapy
  • Abiraterone Acetate
  • Prednisone
  • Computed Tomography
  • Abiraterone
  • PSMA PET Scan

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Washington

Lead sponsor

Blue Earth Diagnostics

Collaborator