Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study
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.
Detailed description
OUTLINE: Patients are assigned to 1 of 3 groups. GROUP I: 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. GROUP II: 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 orally (PO) once daily (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. GROUP III: Patients undergo fluciclovine or PSMA PET/CT and who have \> 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II. After completion of study treatment, patients are followed up at 37, 49, 61, 73, 85, 97, 109, and 121 weeks, at 36, 42, 48, 54, 60, and 66 months, and then annually thereafter.
Arms & interventions
- ProcedurePositron Emission Tomography
Undergo fluciclovine PET/CT
- ProcedureLymphadenectomy
Undergo lymphadenectomy
- RadiationRadiation Therapy
Undergo radiation therapy
- DrugAbiraterone Acetate
Given PO
- DrugPrednisone
Given PO
- ProcedureComputed Tomography
Undergo fluciclovine PET/CT
- DrugAbiraterone
Given PO
- ProcedurePSMA PET Scan
Undergo PSMA PET scan
Outcome measures
Primary
Undetectable PSA (< 0.2 ng/mL) rate
Time frame: At 2 years
Secondary
Total testosterone
Time frame: Up to 7 years
Median time to reinitiation of antiandrogen therapy (ADT)
Time frame: Up to 7 years
Overall survival
Time frame: Up to 7 years
Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL
Time frame: Up to 7 years
Number of patients without abnormalities with PSA < 10 ng/mL
Time frame: Up to 7 years
Number of patients with PSA < 10 mg/mL and > 3 regions of metastatic prostate cancer on fluciclovine PET/CT
Time frame: Up to 7 years
Eligibility criteria
Study locations (2)
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109