Clinical Trials /

Fluciclovine (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study

NCT04175431

Description:

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

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Fluciclovine (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
  • Official Title: Fluciclovine (FACBC) PET/CT Site-Directed Therapy of Oligometastatic Prostate Cancer (Flu-BLAST-PC)

Clinical Trial IDs

  • ORG STUDY ID: RG1004972
  • SECONDARY ID: NCI-2019-07437
  • SECONDARY ID: P30CA015704
  • SECONDARY ID: 10349
  • NCT ID: NCT04175431

Conditions

  • Prostate Adenocarcinoma
  • PSA Level Greater Than or Equal to 0.5
  • PSA Level Less Than Ten

Interventions

DrugSynonymsArms
Abiraterone Acetate154229-18-2, Yonsa, Zytiga, Androsta-5Group II (surgery, radiotherapy, abiraterone, prednisone)
PrednisoneDeltasone, Prednicort, Prednisone Intensol, Rayos, Sterapred, Dehydrocortisone, Prednilonga, ServisoneGroup II (surgery, radiotherapy, abiraterone, prednisone)
Abiraterone154229-19-3, 17-(3-Pyridyl)androsta-5, 16-dien-3beta-ol, CB 7598Group II (surgery, radiotherapy, abiraterone, prednisone)

Purpose

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

Detailed Description

      OUTLINE: Patients are assigned to 1 of 3 groups.

      GROUP I: Patients undergo fluciclovine PET/CT and who do not have any abnormalities outside
      the prostatic fossa by fluciclovine PET/CT imaging undergo PSA recheckes every 3 months, and
      undergo fluciclovine PET/CT once PSA is > 2 ng/ml. If still no abnormalities are found
      outside of the prostatic fossa, patients continue to undergo PSA recheckes every 3 months,
      and undergo fluciclovine 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 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. 6 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 abiraterone acetate and
      prednisone.

      GROUP III: Patients undergo fluciclovine 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.
    

Trial Arms

NameTypeDescriptionInterventions
Group I (fluciclovine PET/CT)Active ComparatorPatients undergo fluciclovine PET/CT and who do not have any abnormalities outside the prostatic fossa by fluciclovine PET/CT imaging undergo PSA recheckes every 3 months, and undergo fluciclovine PET/CT once PSA is > 2 ng/ml. If still no abnormalities are found outside of the prostatic fossa, patients continue to undergo PSA recheckes every 3 months, and undergo fluciclovine PET/CT once PSA is > 5 ng/ml. Patients are off study for treatment plan once PSA reaches 10 ng/ml.
    Group II (surgery, radiotherapy, abiraterone, prednisone)ExperimentalPatients undergo fluciclovine 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. 6 weeks after surgery, patients receive abiraterone acetate 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 abiraterone acetate and prednisone.
    • Abiraterone Acetate
    • Prednisone
    • Abiraterone
    Group III (abiraterone, prednisone)ExperimentalPatients undergo fluciclovine PET/CT and who have > 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II.
    • Abiraterone Acetate
    • Prednisone
    • Abiraterone

    Eligibility Criteria

            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
    
              -  PSA doubling time must be calculated utilizing all PSA measurements from most recent
                 biochemically-recurred (BCR). 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 28 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 able to understand and authorize informed consent
    
            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 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Undetectable PSA (< 0.2 ng/mL) rate
    Time Frame:At 2 years
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Total testosterone
    Time Frame:Up to 7 years
    Safety Issue:
    Description:
    Measure:Median time to reinitiation of antiandrogen therapy (ADT)
    Time Frame:Up to 7 years
    Safety Issue:
    Description:
    Measure:Overall survival
    Time Frame:Up to 7 years
    Safety Issue:
    Description:
    Measure:Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL
    Time Frame:Up to 7 years
    Safety Issue:
    Description:
    Measure:Number of patients without abnormalities with PSA < 10 ng/mL
    Time Frame:Up to 7 years
    Safety Issue:
    Description:
    Measure: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
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University of Washington

    Last Updated

    June 4, 2021