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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 : March 4, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Blue Earth Diagnostics
Information provided by (Responsible Party):
University of Washington

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.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma PSA Level Greater Than or Equal to 0.5 PSA Level Less Than Ten Diagnostic Test: fluciclovine-PET/CT scan Procedure: Lymphadenectomy Radiation: Radiation Therapy Drug: Abiraterone Acetate Drug: Prednisone Other: LHRH agent Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fluciclovine (FACBC) PET/CT Site-Directed Therapy of Oligometastatic Prostate Cancer (Flu-BLAST-PC)
Estimated Study Start Date : March 25, 2020
Estimated Primary Completion Date : July 1, 2026
Estimated Study Completion Date : July 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.
Diagnostic Test: fluciclovine-PET/CT scan
Undergo fluciclovine PET/CT
Other Names:
  • Medical Imaging
  • PET Scan
  • Positron Emission Tomography
  • Computed Tomography
  • CAT 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.
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

Experimental: Group III (ADT/abiraterone/prednisone)
Patients who have > 3 regions of metastatic disease receive ADT, abiraterone acetate, and prednisone as in Group II.
Diagnostic Test: fluciclovine-PET/CT scan
Undergo fluciclovine PET/CT
Other Names:
  • Medical Imaging
  • PET Scan
  • Positron Emission Tomography
  • Computed Tomography
  • CAT Scan

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




Primary Outcome Measures :
  1. Undetectable PSA (< 0.2 ng/mL) rate [ Time Frame: At 2 years ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175431


Contacts
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Contact: Rachel Kang 206-606-1097 rkang123@seattlecca.org

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Contact: Rachel Kang         
Principal Investigator: Evan Yu         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Blue Earth Diagnostics
Investigators
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Principal Investigator: Evan Yu Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT04175431    
Other Study ID Numbers: RG1004972
NCI-2019-07437 ( Registry Identifier: NCI / CTRP )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Prednisone
Abiraterone Acetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors