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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04175431
Recruitment Status : Not yet recruiting
First Posted : November 25, 2019
Last Update Posted : April 30, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Blue Earth Diagnostics
Information provided by (Responsible Party):
University of Washington

Tracking Information
First Submitted Date  ICMJE November 7, 2019
First Posted Date  ICMJE November 25, 2019
Last Update Posted Date April 30, 2020
Estimated Study Start Date  ICMJE May 28, 2020
Estimated Primary Completion Date July 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2019)
Undetectable PSA (< 0.2 ng/mL) rate [ Time Frame: At 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2019)
  • Total testosterone [ Time Frame: Up to 7 years ]
  • Median time to reinitiation of antiandrogen therapy (ADT) [ Time Frame: Up to 7 years ]
  • Overall survival [ Time Frame: Up to 7 years ]
  • Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL [ Time Frame: Up to 7 years ]
  • Number of patients without abnormalities with PSA < 10 ng/mL [ Time Frame: Up to 7 years ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluciclovine (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
Official Title  ICMJE Fluciclovine (FACBC) PET/CT Site-Directed Therapy of Oligometastatic Prostate Cancer (Flu-BLAST-PC)
Brief Summary 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Adenocarcinoma
  • PSA Level Greater Than or Equal to 0.5
  • PSA Level Less Than Ten
Intervention  ICMJE
  • Diagnostic Test: fluciclovine-PET/CT scan
    Undergo fluciclovine PET/CT
    Other Names:
    • Medical Imaging
    • PET Scan
    • Positron Emission Tomography
    • Computed Tomography
    • CAT Scan
  • Procedure: Lymphadenectomy
    Undergo lymphadenectomy
    Other Names:
    • Lymph Node Dissection
    • lymph node excision
  • Radiation: Radiation Therapy
    Undergo radiation therapy
    Other Names:
    • Cancer Radiotherapy
    • Irradiation
    • Radiotherapeutics
    • RT
  • Drug: Abiraterone Acetate
    Given PO
    Other Names:
    • 154229-18-2
    • Yonsa
    • Zytiga
  • Drug: Prednisone
    Given PO
    Other Names:
    • Deltasone
    • Prednicort
    • Prednisone Intensol
    • Rayos
    • Sterapred
  • Other: LHRH agent
    ADT with LHRH agent
Study Arms  ICMJE
  • Active Comparator: Group I (observation with fluciclovine PET/CT)
    Patients 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.
    Intervention: Diagnostic Test: fluciclovine-PET/CT scan
  • Experimental: 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 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.
    Interventions:
    • Diagnostic Test: fluciclovine-PET/CT scan
    • Procedure: Lymphadenectomy
    • Radiation: Radiation Therapy
    • Drug: Abiraterone Acetate
    • Drug: Prednisone
    • Other: LHRH agent
  • Experimental: Group III (ADT/abiraterone/prednisone)
    Patients who have > 3 regions of metastatic disease receive ADT, abiraterone acetate, and prednisone as in Group II.
    Interventions:
    • Diagnostic Test: fluciclovine-PET/CT scan
    • Drug: Abiraterone Acetate
    • Drug: Prednisone
    • Other: LHRH agent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 20, 2019)
165
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2026
Estimated Primary Completion Date July 1, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rachel Kang 206-606-1097 rkang123@seattlecca.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04175431
Other Study ID Numbers  ICMJE RG1004972
NCI-2019-07437 ( Registry Identifier: NCI / CTRP )
P30CA015704 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Blue Earth Diagnostics
Investigators  ICMJE
Principal Investigator: Evan Yu Fred Hutch/University of Washington Cancer Consortium
PRS Account University of Washington
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP