Site-directed therapy using PSMA or FACBC PET/CT for prostate cancer treatment
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 study is testing if using special imaging techniques to guide targeted treatments can help men with prostate cancer get better results from their therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | radiation, prednisone |
| Locations | 2 sites (Pittsburgh, Pennsylvania and 1 other locations) |
| Trial ID | NCT04175431 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of prostate specific membrane antigen (PSMA) or fluciclovine PET/CT in guiding site-directed therapy for patients with prostate adenocarcinoma. Patients are divided into three groups based on the presence of metastatic disease detected by PET/CT, with treatment options including lymphadenectomy, radiation therapy, and abiraterone acetate combined with prednisone. The study aims to monitor PSA levels and assess the benefits of targeted treatment based on imaging results. Follow-up assessments will occur over several years to evaluate long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed prostate adenocarcinoma who have undergone radical prostatectomy and have specific PSA levels indicating biochemical recurrence.
Not a fit: Patients with PSA levels outside the specified range or those who have not undergone prior radical prostatectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment strategies for prostate cancer patients.
How similar studies have performed: Other studies have shown promise in using PET imaging for targeted therapy in prostate cancer, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
Pittsburgh, Pennsylvania and 1 other locations
- University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh, Pennsylvania, United States (Recruiting)
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Evan Yu — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Jane Romani
- Email: jromani@fredhutch.org
- Phone: 206-606-1909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.