Prostate Adenocarcinoma Clinical Trial
Official title:
Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 1, 2031 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 - 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: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania |
United States | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Blue Earth Diagnostics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Undetectable PSA (< 0.2 ng/mL) rate | At 2 years | ||
Secondary | Total testosterone | Up to 7 years | ||
Secondary | Median time to reinitiation of antiandrogen therapy (ADT) | Up to 7 years | ||
Secondary | Overall survival | Up to 7 years | ||
Secondary | Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL | Up to 7 years | ||
Secondary | Number of patients without abnormalities with PSA < 10 ng/mL | Up to 7 years | ||
Secondary | Number of patients with PSA < 10 mg/mL and > 3 regions of metastatic prostate cancer on fluciclovine PET/CT | Up to 7 years |
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