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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Adenocarcinoma

Intervention / Treatment
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* Procedure: Positron Emission Tomography
* Procedure: Lymphadenectomy
* Radiation: Radiation Therapy
* Drug: Abiraterone Acetate
* Drug: Prednisone
* Procedure: Computed Tomography
* Drug: Abiraterone
* Procedure: PSMA PET Scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (fluciclovine PET/CT)<br>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<br>* Undergo fluciclovine PET/CT<br>* Other names: Positron-Emission Tomography;Procedure: Computed Tomography<br>* Undergo fluciclovine PET/CT<br>* Other names: CT Scan;Procedure: PSMA PET Scan<br>* Undergo PSMA PET scan<br>* Other names: PSMA-Positron emission tomography;|
| Experimental: Group II (surgery, radiotherapy, abiraterone, prednisone)<br>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. | Procedure: Positron Emission Tomography<br>* Undergo fluciclovine PET/CT<br>* Other names: Positron-Emission Tomography;Procedure: Lymphadenectomy<br>* Undergo lymphadenectomy<br>* Other names: excision of the lymph node;Radiation: Radiation Therapy<br>* Undergo radiation therapy<br>* Other names: NOS;Drug: Abiraterone Acetate<br>* Given PO<br>* Other names: Androsta-5;Drug: Prednisone<br>* Given PO<br>* Other names: Servisone;Procedure: Computed Tomography<br>* Undergo fluciclovine PET/CT<br>* Other names: CT Scan;Drug: Abiraterone<br>* Given PO<br>* Other names: CB 7598;Procedure: PSMA PET Scan<br>* Undergo PSMA PET scan<br>* Other names: PSMA-Positron emission tomography;|
| Experimental: Group III (abiraterone, prednisone)<br>Patients undergo fluciclovine or PSMA PET/CT and who have > 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II. | Procedure: Positron Emission Tomography<br>* Undergo fluciclovine PET/CT<br>* Other names: Positron-Emission Tomography;Drug: Abiraterone Acetate<br>* Given PO<br>* Other names: Androsta-5;Drug: Prednisone<br>* Given PO<br>* Other names: Servisone;Procedure: Computed Tomography<br>* Undergo fluciclovine PET/CT<br>* Other names: CT Scan;Drug: Abiraterone<br>* Given PO<br>* Other names: CB 7598;Procedure: PSMA PET Scan<br>* Undergo PSMA PET scan<br>* Other names: PSMA-Positron emission tomography;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |