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RecruitingNCT04175431Updated Jul 7, 2026

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

A Phase 2 interventional study of Positron Emission Tomography and Lymphadenectomy in Prostate Adenocarcinoma, sponsored by University of Washington. Recruiting at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by University of Washington · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2020; still recruiting 6 years later.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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.

Read the detailed description

OUTLINE: Patients are assigned to 1 of 3 groups.

GROUP I: Patients for whom initial fluciclovine or PSMA PET/CT does not reveal any abnormalities outside the prostatic fossa undergo PSA rechecks every 3 months, and undergo fluciclovine or PSMA PET/CT once PSA is > 2 ng/ml. If still no abnormalities are found outside of the prostatic fossa, patients continue to undergo PSA rechecks every 3 months, and undergo fluciclovine or PSMA PET/CT once PSA is > 5 ng/ml. Patients are off study for treatment plan once PSA reaches 10 ng/ml.

GROUP II: Patients undergo fluciclovine or PSMA PET/CT and who have =\< 3 regions of metastatic disease outside of the prostatic fossa that are amenable to metastasis-directed therapy undergo lymphadenectomy or radiation therapy. Six to ten weeks after surgery, patients receive abiraterone acetate 1000 mg orally (PO) once daily (QD) and prednisone PO QD. Treatment repeats every 4 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may start radiation therapy after 2 cycles of abiraterone acetate and prednisone.

GROUP III: Patients undergo fluciclovine or PSMA PET/CT and who have > 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II.

After completion of study treatment, patients are followed up at 37, 49, 61, 73, 85, 97, 109, and 121 weeks, at 36, 42, 48, 54, 60, and 66 months, and then annually thereafter.

02

Conditions studied

  • Prostate Adenocarcinoma
03

In context

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Expected lifespan of less than 12 weeks
  • Inability to lay still for imaging
  • Weight > 300 lbs. (due to equipment specifications)
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Group I (fluciclovine PET/CT)

    Patients for whom initial fluciclovine or PSMA PET/CT does not reveal any abnormalities outside the prostatic fossa undergo PSA rechecks every 3 months, and undergo fluciclovine or PSMA PET/CT once PSA is \> 2 ng/ml. If still no abnormalities are found outside of the prostatic fossa, patients continue to undergo PSA rechecks every 3 months, and undergo fluciclovine or PSMA PET/CT once PSA is \> 5 ng/ml. Patients are off study for treatment plan once PSA reaches 10 ng/ml.

    Procedure: Positron Emission Tomography · Procedure: Computed Tomography · Procedure: PSMA PET Scan

  • Experimental
    Group II (surgery, radiotherapy, abiraterone, prednisone)

    Patients undergo fluciclovine or PSMA PET/CT and who have =\< 3 regions of metastatic disease outside of the prostatic fossa that are amenable to metastasis-directed therapy undergo lymphadenectomy or radiation therapy. Six to ten weeks after surgery, patients receive abiraterone acetate 1000 mg PO QD and prednisone PO QD. Treatment repeats every 4 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may start radiation therapy after 2 cycles of abiraterone acetate and prednisone.

    Procedure: Positron Emission Tomography · Procedure: Lymphadenectomy · Radiation: Radiation Therapy · Drug: Abiraterone Acetate · Drug: Prednisone · Procedure: Computed Tomography · Drug: Abiraterone · Procedure: PSMA PET Scan

  • Experimental
    Group III (abiraterone, prednisone)

    Patients undergo fluciclovine or PSMA PET/CT and who have \> 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II.

    Procedure: Positron Emission Tomography · Drug: Abiraterone Acetate · Drug: Prednisone · Procedure: Computed Tomography · Drug: Abiraterone · Procedure: PSMA PET Scan

Interventions

  • ProcedurePositron Emission Tomography

    Undergo fluciclovine PET/CT

    Also known as: Medical Imaging, PET Scan, positron emission tomography scan, proton magnetic resonance spectroscopic imaging, Positron-Emission Tomography

  • ProcedureLymphadenectomy

    Undergo lymphadenectomy

    Also known as: Lymph Node Dissection, lymph node excision, excision of the lymph node

  • RadiationRadiation Therapy

    Undergo radiation therapy

    Also known as: Cancer Radiotherapy, Irradiation, Radiotherapeutics, RT, ENERGY_TYPE, Irradiated, Therapy, Radiation, NOS

  • DrugAbiraterone Acetate

    Given PO

    Also known as: 154229-18-2, Yonsa, Zytiga, Androsta-5

  • DrugPrednisone

    Given PO

    Also known as: Deltasone, Prednicort, Prednisone Intensol, Rayos, Sterapred, Dehydrocortisone, Prednilonga, Servisone

  • ProcedureComputed Tomography

    Undergo fluciclovine PET/CT

    Also known as: CAT Scan, CAT, computerized axial tomography, computerized tomography, CT Scan

  • DrugAbiraterone

    Given PO

    Also known as: 154229-19-3, 17-(3-Pyridyl)androsta-5, 16-dien-3beta-ol, CB 7598

  • ProcedurePSMA PET Scan

    Undergo PSMA PET scan

    Also known as: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

06

What researchers measure

Primary outcomes

  1. Undetectable PSA (< 0.2 ng/mL) rate

    Time frame: At 2 years

Secondary outcomes

  1. Total testosterone

    Time frame: Up to 7 years

  2. Median time to reinitiation of antiandrogen therapy (ADT)

    Time frame: Up to 7 years

  3. Overall survival

    Time frame: Up to 7 years

  4. Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL

    Time frame: Up to 7 years

  5. Number of patients without abnormalities with PSA < 10 ng/mL

    Time frame: Up to 7 years

  6. Number of patients with PSA < 10 mg/mL and > 3 regions of metastatic prostate cancer on fluciclovine PET/CT

    Time frame: Up to 7 years

07

Study locations

2 of 2 sites recruiting
  • University of Pittsburgh Cancer Institute (UPCI)
    Pittsburgh, Pennsylvania 15232, United States
    • Risa Wong · Principal investigator
    Recruiting
  • Fred Hutch/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04175431
Lead sponsor
University of Washington
Collaborators
Blue Earth Diagnostics
Responsible party
Sponsor
First posted
Nov 25, 2019
Start date
Sep 30, 2020
Primary completion
Jul 1, 2032 (estimated)
Completion
Jul 1, 2037 (estimated)
Last update
Jul 7, 2026

Study contacts

Jane Romani
Contact
jromani@fredhutch.org
206-606-1909
Evan Yu
principal investigator · Fred Hutch/University of Washington Cancer Consortium

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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