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18F-fluciclovine PET in Metastatic Castration Resistant Prostate Cancer Treated With Abiraterone Acetate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158245
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : May 8, 2020
Sponsor:
Collaborator:
Blue Earth Diagnostics
Information provided by (Responsible Party):
Tulane University

Brief Summary:
This is a pilot phase 2 single-arm study, of men with metastatic castration-resistant prostate cancer (mCRPC). Patients will be treated with abiraterone acetate 1000 mg daily plus prednisone 5 mg (or dexamethasone 0.5 mg) daily for mCRPC.

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Drug: 18F-fluciclovine PET Scan Phase 2

Detailed Description:

Prostate cancer is a hormonally-driven disease and androgens are key in the growth of both normal prostate and prostate cancer cells. Once mCRPC is evident, most patients receive a second-generation hormonal therapy to further suppress the synthesis or androgens (abiraterone) and to block androgen receptor (AR) activation, nuclear translocation and DNA binding (enzalutamide).

Conventional imaging of prostate cancer has limitations in staging, restaging after biochemical relapse, and response assessment. Functional imaging with positron emission tomography (PET) can target various aspects of tumor biology and is clearly superior in the detection of extra-prostatic disease. 18F-fluciclovine is a synthetic amino acid transported across mammalian cell membranes by amino acid transporters that are upregulated in prostate cancer cells.

18F-fluciclovine is approved for PET imaging to identify sites of prostate cancer recurrence in men with rising prostate specific antigen (PSA) following prior definitive treatment. This study describes the changes in 18F-fluciclovine PET scan and compare these results with PSA and conventional computerized tomography (CT) and bone scans, in mCRPC patients treated with abiraterone acetate-prednisone.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Describe the changes in the 18F-fluciclovine Positron Emission Tomography (PET) in patients with metastatic castration resistant prostate cancer treated with abiraterone acetate.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Changes in 18F-fluciclovine Positron Emission Tomography (PET) in Patients With Metastatic Castration Resistant Prostate Cancer Treated With Abiraterone Acetate: A Pilot Study
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-fluciclovine PET Scan
Single intravenous administration of 18F-fluciclovine for PET Scan.
Drug: 18F-fluciclovine PET Scan
The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in PSA, allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.
Other Name: Axumin




Primary Outcome Measures :
  1. Changes in 18F-fluciclovine PET scan for patients with mCRPC on treatment with abiraterone-prednisone [ Time Frame: 12 weeks ]
    To describe the 18F-fluciclovine PET findings for patients with mCRPC prior to starting treatment with abiraterone-prednisone, and at 12 weeks after abiraterone therapy initiation.

  2. PET scan vs. conventional CT and bone scan [ Time Frame: 12 weeks ]
    A comparison of 18F-fluciclovine PET with conventional CT and bone scans for patients with mCRPC prior to starting treatment with abiraterone-prednisone, and at 12 weeks after starting abiraterone; and to correlate these changes with PSA response and progression after starting abiraterone.


Other Outcome Measures:
  1. Compare the PET scan results with the genomic alterations in circulating tumor deoxyribonucleic acid (ctDNA) [ Time Frame: 12 weeks ]
    To understand disease heterogeneity and possible heterogenous progression and change in patient management as well as to compare the 18F-fluciclovine PET findings with genomic alterations found in ctDNA especially in the androgen receptor (AR) gene, using an NGS assay of patients with mCRPC treated with abiraterone



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 18 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2;
  2. Age ≥ 18 years;
  3. Histologically confirmed adenocarcinoma of the prostate;
  4. Ongoing use of luteinizing hormone-releasing hormone (LHRH) required in the absence of surgical castration and castrate concentration of testosterone (< 50 ng/dL);
  5. Detectable PSA of at least 2 ng/dL;
  6. Metastatic disease documented by CT or bone scan within 42 days of cycle 1 day 1;
  7. Life expectancy of ≥ 6 months;
  8. Must have disease progression despite a castrate concentration of testosterone of < 50 ng/dL based on:

    A. PSA progression defined as increase in PSA of at least 2 ng/dL and 25% from nadir values of prior therapy, determined by 2 separate measurement taken at least 1 week apart;

    And/or

    B. Radiographic disease progression based on response evaluation criteria in solid tumors (RECIST) 1.1 for soft tissue disease and/or prostate cancer working group 3 (PCWG3) for bone only disease;

  9. No prior life-prolonging therapies for mCRPC are allowed, except Sipuleucel-T;
  10. The use of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is allowed;
  11. Low dose prednisone (10 mg or less) or equivalent is allowed;
  12. Acceptable liver function (within 28 days from enrollment) defined as:

    A. Bilirubin < 2.5 times upper limit of normal (ULN), except for patients with known Gilbert disease (in such cases bilirubin < 5 times ULN);

    B. AST (SGOT) and ALT (SGPT) < 3 times ULN

  13. Acceptable renal function (within 28 days from enrollment):

    A. Serum creatinine ≤ 2.0 x ULN or creatinine clearance ≥ 30 mL/min

  14. Acceptable hematologic status (within 28 days from enrollment):

    A. Absolute neutrophil count (ANC) ≥ 1000 cell/mm3 (100 x 109/L)

    B. Platelet count ≥ 100,000 platelet/mm3 (100 x 109/L)

    C. Hemoglobin ≥ 9 g/dL

  15. At least 2 weeks since prior radiation before starting study treatment (cycle 1 day 1);
  16. Able to understand and willing to sign a written informed consent document;
  17. Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate.

Exclusion Criteria:

  1. Pathological findings consistent with small cell carcinoma of the prostate;
  2. Prior treatment with docetaxel for metastatic castration-resistant prostate cancer (CRPC);
  3. Patient with normal 18F-flucicolovine PET/CT scans at baseline;
  4. Know allergies, hypersensitivity, or intolerance to abiraterone, prednisone, 18F-fluciclovine or their excipients;
  5. Any chronic medical condition requiring ≥ 10 mg daily of systemic prednisone (or equivalent);
  6. Major surgery (e.g., required general anesthesia) within 2 weeks before screening;
  7. Uncontrolled active infection (including hepatitis B or C or AIDS). Patients with hepatitis B/C who have disease under control and no significant liver function impairment, and undetectable viral load will be allowed to participate. Similarly, patients with known HIV and ≥ 400 CD4 + T cells are allowed to participate;
  8. Evidence of other metastatic malignancies within the last year;
  9. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158245


Contacts
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Contact: Pedro C. Barata, MD, MSc (504) 988-6300 pbarata@tulane.edu

Locations
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United States, Louisiana
Tulane Cancer Center Clinic Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Patrick Cotogno    504-988-6542    pcotogno@tulane.edu   
Principal Investigator: Pedro Barata, MD         
Sponsors and Collaborators
Tulane University
Blue Earth Diagnostics
Investigators
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Principal Investigator: Pedro C. Barata, MD, MSc Tulane University School of Medicine
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Responsible Party: Tulane University
ClinicalTrials.gov Identifier: NCT04158245    
Other Study ID Numbers: BED-IIT-382
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases