Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT04175431

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

Led by University of Washington · Updated on 2025-12-18

100

Participants Needed

2

Research Sites

665 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

B

Blue Earth Diagnostics

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological or cytological confirmation of prostate adenocarcinoma
  • Previous radical prostatectomy
  • Prior adjuvant or salvage radiation therapy to the prostatic fossa with or without whole pelvis
  • PSA level between 0.2 and less than 10 ng/mL with at least two confirmatory PSA values if only one elevated
  • PSA doubling time between 3 and 18 months calculated using recent PSA measurements
  • No prior radiographic evidence of metastatic prostate cancer by conventional CT and bone scan
  • Total testosterone level greater than 120 ng/dL within 42 days before enrollment
  • ECOG performance status 0 or 1
  • Absolute neutrophil count of at least 1.0 x 10^9/L
  • Platelet count of at least 100 x 10^9/L
  • Hemoglobin level of at least 9 g/dL
  • Potassium level of at least 3.5
  • Serum bilirubin less than or equal to 1.5 times the upper limit of normal or up to 3 times for Gilbert's syndrome
  • ALT and AST levels less than or equal to 3 times the upper limit of normal
  • Creatinine clearance of at least 30 mL/min estimated or measured
  • At least 18 years old at consent
  • Able to understand and provide informed consent
Not Eligible

You will not qualify if you...

  • Chronic active hepatitis B or C
  • History of a second non-prostate cancer requiring systemic therapy in the past 2 years except certain skin or bladder cancers
  • Serious medical conditions impairing ability to undergo PET/CT imaging or treatment
  • Any condition affecting mental status that prevents understanding or consenting
  • Expected lifespan less than 12 weeks
  • Unable to remain still during imaging
  • Weight over 300 pounds due to equipment limits
  • Any other medical condition that may interfere with treatment or follow-up as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

2

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

J

Jane Romani

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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