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) improves long-term outcomes by facilitating early identification of metastatic prostate cancer amenable to both systemic and site-directed definitive therapy.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Not yet 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
  • 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, ZytigaGroup II (ADT/abiraterone/prednisone +/- surgery +/- RT)
PrednisoneDeltasone, Prednicort, Prednisone Intensol, Rayos, SterapredGroup II (ADT/abiraterone/prednisone +/- surgery +/- RT)

Purpose

This phase II trial studies how well fluciclovine positron emission tomography (PET)/computed tomography (CT) improves long-term outcomes by facilitating early identification of metastatic prostate cancer amenable to both systemic and site-directed definitive therapy.

Detailed Description

      OUTLINE: Patients are assigned to 1 of 3 groups.

      GROUP I (observation with fluciclovine PET/CT): Patients who do not have any abnormalities
      outside the prostatic fossa by fluciclovine PET/CT imaging undergo prostate-specific antigen
      (PSA) rechecks every 3 months once PSA is > 2 ng/ml. If still no abnormalities are found,
      patients continue to undergo PSA rechecks every 3 months once PSA is > 5 ng/ml. Patients are
      off study once PSA reaches 10 ng/ml.

      GROUP II (ADT/abiraterone/prednisone +/- surgery +/- RT): Patients who have =< 3 regions of
      metastatic disease outside the prostatic fossa may undergo lymphadenectomy and/or radiation
      therapy, depending on the location of metastases. Patients with surgically treatable disease
      receive androgen deprivation therapy (ADT) comprising any luteinizing hormone-releasing
      hormone (LHRH) agent, abiraterone acetate 1000 mg orally (PO) once daily (QD), and prednisone
      PO QD 6 weeks after surgery. Patients with radiation treatable disease receive 2 cycles of
      ADT, abiraterone acetate, and prednisone followed by radiation therapy. Treatment repeats
      every 4 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.

      GROUP III (ADT/abiraterone/prednisone): Patients who have > 3 regions of metastatic disease
      receive ADT, abiraterone acetate, and prednisone as in Group II.

      After completion of study treatment, patients are followed up every 3 months for 2 years,
      every 6 months for 3 years, then annually thereafter.
    

Trial Arms

NameTypeDescriptionInterventions
Group I (observation with fluciclovine PET/CT)Active ComparatorPatients who do not have any abnormalities outside the prostatic fossa by fluciclovine PET/CT imaging undergo PSA rechecks every 3 months once PSA is > 2 ng/ml. If still no abnormalities are found, patients continue to undergo PSA rechecks every 3 months once PSA is > 5 ng/ml. Patients are off study once PSA reaches 10 ng/ml.
    Group II (ADT/abiraterone/prednisone +/- surgery +/- RT)ExperimentalPatients who have =< 3 regions of metastatic disease outside the prostatic fossa may undergo lymphadenectomy and/or radiation therapy, depending on the location of metastases. Patients with surgically treatable disease receive ADT comprising any LHRH agent, abiraterone acetate 1000 mg PO QD, and prednisone PO QD 6 weeks after surgery. Patients with radiation treatable disease receive 2 cycles of ADT, abiraterone acetate, and prednisone followed by radiation therapy. Treatment repeats every 4 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.
    • Abiraterone Acetate
    • Prednisone
    Group III (ADT/abiraterone/prednisone)ExperimentalPatients who have > 3 regions of metastatic disease receive ADT, abiraterone acetate, and prednisone as in Group II.
    • Abiraterone Acetate
    • Prednisone

    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:Not yet recruiting
    Lead Sponsor:University of Washington

    Last Updated

    November 20, 2019