Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
Recruiting
Phase 2Interventional Study
Prostate Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
University of Washington · Other
Who this trial is looking for
This trial is looking for men who have been diagnosed with prostate cancer and have previously had surgery and radiation treatment. Participants will undergo special imaging to see if they can benefit from targeted therapy.
Are You a Good Fit for This Trial?
You may be able to join if
I have prostate adenocarcinoma.
I have had a radical prostatectomy.
I have had radiation therapy to the prostatic area.
My PSA level is between 0.2 and 10 ng/mL.
I am at least 18 years old.
I can understand and give consent for this trial.
My testosterone level is above 120 ng/dL.
I have good overall health.
You may not be able to join if
I have chronic active hepatitis B or C.
I have had another cancer that needed treatment in the last 2 years.
I have a serious medical condition that affects my ability to participate.
I have a mental condition that prevents me from understanding consent.
I am expected to live less than 12 weeks.
I cannot lie still for imaging tests.
I weigh more than 300 lbs.
I have another condition that my doctor thinks would prevent me from participating.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Locations
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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 +/- whol…
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
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