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New treatment option for Prostate Adenocarcinoma
Official title Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
ClinicalTrials.gov ID: NCT04175431
What this study is testing
What is Abiraterone Acetate?
Abiraterone Acetate is an investigational medicine, being studied as a potential treatment for prostate adenocarcinoma.
Also referred to as 154229-18-2, Yonsa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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 \ = 0.2 with this biochemical recurrence, a second PSA value must be confirmed to be...
- PSA doubling time must be calculated utilizing either all PSA measurements \> 0.1 ng/mL from most recent biochemically-recurred (BCR) or the most...
You likely can't join 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...
- Patient with a serious underlying medical condition that would otherwise impair the patient's ability to undergo fluciclovine or PSMA PET/CT imaging...
- 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
See the full eligibility 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 \ = 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...
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.