Prostate Cancer Clinical Trial

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

Summary

This phase II trial studies how well fluciclovine positron emission tomography (PET)/computed tomography (CT) site-directed therapy works for treating patients with prostate cancer. Fluciclovine PET/CT may detect prostate cancer early and may help to show whether patients benefit from site directed treatment to PET detected abnormalities.

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Full Description

OUTLINE: Patients are assigned to 1 of 3 groups.

GROUP I: Patients undergo fluciclovine PET/CT and who do not have any abnormalities outside the prostatic fossa by fluciclovine PET/CT imaging undergo PSA recheckes every 3 months, and undergo fluciclovine PET/CT once PSA is > 2 ng/ml. If still no abnormalities are found outside of the prostatic fossa, patients continue to undergo PSA recheckes every 3 months, and undergo fluciclovine 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 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. 6 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 abiraterone acetate and prednisone.

GROUP III: Patients undergo fluciclovine 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.

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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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

165

Study ID:

NCT04175431

Recruitment Status:

Recruiting

Sponsor:

University of Washington

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There is 1 Location for this study

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Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States More Info
Natalie Mutter
Contact
206-606-1230
[email protected]
Evan Yu
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

165

Study ID:

NCT04175431

Recruitment Status:

Recruiting

Sponsor:


University of Washington

How clear is this clinincal trial information?

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