Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
NCT ID: NCT04175431
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2020-09-30
2033-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Positron Emission Tomography
Undergo fluciclovine PET/CT
Computed Tomography
Undergo fluciclovine PET/CT
PSMA PET Scan
Undergo PSMA PET scan
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.
Positron Emission Tomography
Undergo fluciclovine PET/CT
Lymphadenectomy
Undergo lymphadenectomy
Radiation Therapy
Undergo radiation therapy
Abiraterone Acetate
Given PO
Prednisone
Given PO
Computed Tomography
Undergo fluciclovine PET/CT
Abiraterone
Given PO
PSMA PET Scan
Undergo PSMA PET scan
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.
Positron Emission Tomography
Undergo fluciclovine PET/CT
Abiraterone Acetate
Given PO
Prednisone
Given PO
Computed Tomography
Undergo fluciclovine PET/CT
Abiraterone
Given PO
PSMA PET Scan
Undergo PSMA PET scan
Interventions
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Positron Emission Tomography
Undergo fluciclovine PET/CT
Lymphadenectomy
Undergo lymphadenectomy
Radiation Therapy
Undergo radiation therapy
Abiraterone Acetate
Given PO
Prednisone
Given PO
Computed Tomography
Undergo fluciclovine PET/CT
Abiraterone
Given PO
PSMA PET Scan
Undergo PSMA PET scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Blue Earth Diagnostics
INDUSTRY
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Evan Yu
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Jane Romani
Role: primary
Other Identifiers
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NCI-2019-07437
Identifier Type: REGISTRY
Identifier Source: secondary_id
10349
Identifier Type: OTHER
Identifier Source: secondary_id
RG1004972
Identifier Type: -
Identifier Source: org_study_id