Study on PSMA or FACBC PET/CT Site-Directed Therapy for Treating Prostate Cancer (Flu-BLAST-PC Study)

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04175431

Provider View

This clinical trial is exploring how well a specific type of imaging, called PSMA or fluciclovine PET/CT, works in guiding treatment for prostate cancer. The study aims to see if this imaging can detect cancer early and help decide if targeted treatment is beneficial.

Patient Parameters

Program Overview

This phase II study is investigating the effectiveness of using PSMA or fluciclovine PET/CT imaging to guide treatment in patients with prostate cancer. The imaging may help detect cancer early and determine if patients benefit from targeted treatment based on the PET/CT findings.

Description

The study involves three groups of patients:

  • Group I: Patients whose initial PET/CT scan shows no cancer outside the prostate area will have their PSA levels checked every 3 months. If PSA levels rise above 2 ng/ml, another PET/CT scan is done. If no cancer is found outside the prostate area, PSA checks continue every 3 months, with another scan if PSA exceeds 5 ng/ml. The study ends for these patients if PSA reaches 10 ng/ml.

  • Group II: Patients with up to 3 areas of cancer outside the prostate area, as shown by PET/CT, will receive surgery or radiation therapy. After 6-10 weeks, they will take abiraterone acetate and prednisone daily for 6 cycles, unless the cancer progresses or side effects are unacceptable. Radiation therapy may start after 2 cycles of medication.

  • Group III: Patients with more than 3 areas of cancer will receive the same medication as Group II.

After treatment, patients will have follow-up visits at various intervals up to 66 months, and then annually.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed prostate cancer.
  • Must have had prostate surgery and radiation therapy.
  • PSA levels between 0.2 and 10 ng/mL, with specific conditions for rising PSA levels.
  • PSA doubling time between 3 and 18 months.
  • No visible metastatic cancer on standard scans.
  • Testosterone level above 120 ng/dL.
  • Good overall health with an ECOG score of 0 or 1.
  • Adequate blood cell counts and organ function.
  • At least 18 years old and able to consent to the study.

Exclusion Criteria

  • Active hepatitis B or C.
  • Recent history of another cancer requiring treatment, except certain skin or bladder cancers.
  • Serious medical conditions affecting imaging or treatment.
  • Mental conditions affecting consent.
  • Life expectancy less than 12 weeks.
  • Inability to stay still for imaging.
  • Weight over 300 lbs.
  • Any other condition affecting treatment or follow-up.

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