Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
3 other identifiers
interventional
100
1 country
2
Brief Summary
This phase II trial studies how well prostate specific membrane antigen (PSMA) or fluciclovine positron emission tomography (PET)/computed tomography (CT) site-directed therapy works for treating patients with prostate cancer. PSMA or fluciclovine PET/CT may detect prostate cancer early and may help to show whether patients benefit from site directed treatment to PET detected abnormalities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2020
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 25, 2019
CompletedStudy Start
First participant enrolled
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2033
December 18, 2025
December 1, 2025
7.8 years
November 7, 2019
December 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Undetectable PSA (< 0.2 ng/mL) rate
At 2 years
Secondary Outcomes (6)
Total testosterone
Up to 7 years
Median time to reinitiation of antiandrogen therapy (ADT)
Up to 7 years
Overall survival
Up to 7 years
Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL
Up to 7 years
Number of patients without abnormalities with PSA < 10 ng/mL
Up to 7 years
- +1 more secondary outcomes
Study Arms (3)
Group I (fluciclovine PET/CT)
ACTIVE COMPARATORPatients 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 (surgery, radiotherapy, abiraterone, prednisone)
EXPERIMENTALPatients 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.
Group III (abiraterone, prednisone)
EXPERIMENTALPatients undergo fluciclovine or PSMA PET/CT and who have \> 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II.
Interventions
Undergo fluciclovine PET/CT
Undergo lymphadenectomy
Undergo radiation therapy
Given PO
Given PO
Undergo fluciclovine PET/CT
Given PO
Undergo PSMA PET scan
Eligibility Criteria
You may qualify if:
- 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
- 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
- +2 more criteria
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Blue Earth Diagnosticscollaborator
Study Sites (2)
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evan Yu
Fred Hutch/University of Washington Cancer Consortium
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 25, 2019
Study Start
September 30, 2020
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2033
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share