Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study

Who is this study for? Adult patients with prostate cancer
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
University of Pittsburgh Cancer Institute (UPCI)
RECRUITING
Pittsburgh
Washington
Fred Hutch/University of Washington Cancer Consortium
RECRUITING
Seattle
Contact Information
Primary
Patrick Panlasigui
ppanlas2@fredhutch.org
206-606-7486
Time Frame
Start Date: 2020-09-30
Estimated Completion Date: 2031-07-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Group I (fluciclovine PET/CT)
Patients for whom initial fluciclovine or PSMA PET/CT does not reveal any abnormalities outside the prostatic fossa undergo PSA rechecks every 3 months, and undergo fluciclovine or PSMA PET/CT once PSA is \> 2 ng/ml. If still no abnormalities are found outside of the prostatic fossa, patients continue to undergo PSA rechecks every 3 months, and undergo fluciclovine or PSMA PET/CT once PSA is \> 5 ng/ml. Patients are off study for treatment plan once PSA reaches 10 ng/ml.
Experimental: Group II (surgery, radiotherapy, abiraterone, prednisone)
Patients undergo fluciclovine or PSMA 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. Six to ten weeks after surgery, patients receive abiraterone acetate 1000 mg PO 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 of abiraterone acetate and prednisone.
Experimental: Group III (abiraterone, prednisone)
Patients undergo fluciclovine or PSMA PET/CT and who have \> 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II.
Related Therapeutic Areas
Sponsors
Collaborators: Blue Earth Diagnostics
Leads: University of Washington

This content was sourced from clinicaltrials.gov