Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study

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 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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Adenocarcinoma
• Intervention / Treatment: Drug: Prednisone; Radiation: Radiation Therapy; Drug: Abiraterone Acetate; Drug: Abiraterone; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Procedure: Lymphadenectomy; Procedure: PSMA PET Scan

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Patrick Panlasigui; Phone Number: 206-606-7486; Email: ppanlas2@fredhutch.org

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Cancer Institute (UPCI)
      • Principal Investigator: Risa Wong
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Principal Investigator: Evan Yu
      • Contact: Patrick Panlasigui; Phone Number: 206-606-7486; Email: ppanlas2@fredhutch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Prednisone; Given PO; Other Names: Deltasone; Prednicort; Prednilonga; Prednisone Intensol; Rayos; Servisone; Dehydrocortisone; Sterapred; Drug: Abiraterone Acetate; Given PO; Other Names: Zytiga; Yonsa; 154229-18-2; Androsta-5; Drug: Abiraterone; Given PO; Other Names: CB 7598; 154229-19-3; 17-(3-Pyridyl)androsta-5; 16-dien-3beta-ol; Procedure: Positron Emission Tomography; Undergo fluciclovine PET/CT; Other Names: PET Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; Medical Imaging; positron emission tomography scan; Procedure: Computed Tomography; Undergo fluciclovine PET/CT; Other Names: CAT; CAT Scan; CT Scan; computerized tomography; computerized axial tomography; Procedure: PSMA PET Scan; Undergo PSMA PET scan; Other Names: PSMA PET; Prostate-specific Membrane Antigen PET; PSMA-Positron emission tomography
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.	Procedure: Positron Emission Tomography; Undergo fluciclovine PET/CT; Other Names: PET Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; Medical Imaging; positron emission tomography scan; Procedure: Computed Tomography; Undergo fluciclovine PET/CT; Other Names: CAT; CAT Scan; CT Scan; computerized tomography; computerized axial tomography; Procedure: PSMA PET Scan; Undergo PSMA PET scan; Other Names: PSMA PET; Prostate-specific Membrane Antigen PET; PSMA-Positron emission tomography
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.	Drug: Prednisone; Given PO; Other Names: Deltasone; Prednicort; Prednilonga; Prednisone Intensol; Rayos; Servisone; Dehydrocortisone; Sterapred; Radiation: Radiation Therapy; Undergo radiation therapy; Other Names: Cancer Radiotherapy; ENERGY_TYPE; Irradiated; Irradiation; Radiotherapeutics; RT; Therapy, Radiation; NOS; Drug: Abiraterone Acetate; Given PO; Other Names: Zytiga; Yonsa; 154229-18-2; Androsta-5; Drug: Abiraterone; Given PO; Other Names: CB 7598; 154229-19-3; 17-(3-Pyridyl)androsta-5; 16-dien-3beta-ol; Procedure: Positron Emission Tomography; Undergo fluciclovine PET/CT; Other Names: PET Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; Medical Imaging; positron emission tomography scan; Procedure: Computed Tomography; Undergo fluciclovine PET/CT; Other Names: CAT; CAT Scan; CT Scan; computerized tomography; computerized axial tomography; Procedure: Lymphadenectomy; Undergo lymphadenectomy; Other Names: excision of the lymph node; Lymph Node Dissection; lymph node excision; Procedure: PSMA PET Scan; Undergo PSMA PET scan; Other Names: PSMA PET; Prostate-specific Membrane Antigen PET; PSMA-Positron emission tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Undetectable PSA (< 0.2 ng/mL) rate	At 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Total testosterone	Up to 7 years
Median time to reinitiation of antiandrogen therapy (ADT)	Up to 7 years
Overall survival	Up to 7 years
Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL	Up to 7 years
Number of patients without abnormalities with PSA < 10 ng/mL	Up to 7 years
Number of patients with PSA < 10 mg/mL and > 3 regions of metastatic prostate cancer on fluciclovine PET/CT	Up to 7 years

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Blue Earth Diagnostics
• Investigators: Principal Investigator: Evan Yu, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Prednisone; Abiraterone Acetate
• Other Study ID Numbers: RG1004972; 10349 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2019-07437 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No