NCT04175431RecruitingPhase 2
Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 7 Nov 2019
- Start date
- 30 Sept 2020
- Primary completion date
- 1 Jul 2032
- Lead sponsor
- University of Washington
- Diseases
- Prostate cancer
- NCT number
- NCT04175431
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 30 Sept 2020 to the primary completion date, 1 Jul 2032
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Any other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and/or follow up
Other
- Expected lifespan of less than 12 weeks
- Inability to lay still for imaging
- Weight \> 300 lbs. (due to equipment specifications)
Who the study is looking for
- 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
- PSA doubling time must be calculated utilizing either all PSA measurements \> 0.1 ng/mL from most recent biochemically-recurred (BCR) or the most recent 3 PSA measurements \> 0.1 ng/mL (if the latter, all 3 PSA measurements must be \> 2 weeks apart to be used in the calculation). PSA doubling time must be \> 3 months and \< 18 months. The Memorial Sloan Kettering PSA doubling time calculator should be used
- Patient must have no previous evidence of radiographically detectable metastatic prostate cancer by conventional CT and bone scan imaging
- Patient must have total testosterone level \> 120 ng/dL demonstrated within 42 days of enrollment
- Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count (ANC) \>= 1.0 X 10\^9/L
- Platelet count \>= 100 X 10\^9/L
- Hemoglobin \>= 9 g/dL
- Potassium \>= 3.5
- Serum bilirubin =\< 1.5 X upper limit of normal (ULN) or =\< 3 X ULN for patients with documented Gilbert's syndrome
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 X ULN
- Creatinine clearance (Cr Cl) \>= 30 mL/min as estimated by the Cockcroft-Gault criteria or as determined by 24 hour Cr Cl measurement
- Patient must be \>= 18 years of age on day of signing informed consent
- Patient must be able to understand and authorize informed consent
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pittsburgh Cancer Institute (UPCI) Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Fred Hutch/University of Washington Cancer Consortium Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.