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Completed

NCT Number: NCT02830880

FACBC Prostate Therapy Response

The purpose of this study is to assess if using anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will be useful in determining if participants are responding to chemotherapy treatment. Investigators will enroll participants whose cancer has been treated with hormone therapy and now the cancer is not responding to the treatment (castration -resistant), and so therefore will be started on chemotherapy. Investigators aim to enroll thirty participants in this study.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Emory University Hospital

Atlanta, Georgia, 30322, United States

About this study

The goal of the investigation is to examine therapeutic monitoring of chemotherapy in castrate resistant prostate carcinoma with anti-3-[18F]FACBC in prostate carcinoma to determine if anti-3-[18F]FACBC amino acid imaging can serve as an accurate and efficient imaging biomarker.

Investigators will perform a baseline anti-3-[18F]FACBC PET-CT of the whole body. All participants will also undergo conventional staging including 99mTc methylene diphosphonate (MDP) bone scanning and computed tomography scan (CT) or magnetic resonance imaging (MR) of the abdomen and pelvis which are standard of care at the enrolling institution. This study will not interfere with standard patient evaluation or delay therapy.

All 30 participants will receive chemotherapy every 3 weeks for 6 cycles. Participants will undergo a repeat anti-3-[18F]FACBC PET-CT after 1 and 6 cycles and also repeat conventional imaging including bone scanning CT or MR of the abdomen and pelvis after 6 cycles. At the end of the study, the study team will then record the response (or lack thereof) on anti-3-[18F]FACBC PET-CT and correlate that response with response per standard clinical criteria including bone scan uptake for skeletal lesions, CT or MR for soft tissue and skeletal lesions, prostate-specific antigen (PSA) progression or regression, and other clinical parameters such as declining performance status.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted therapy including luteinizing hormone-releasing hormone (LHRH) agonists (Lupron or Trelstar), other anti-androgens, and/or Abiraterone or Enzalutamide may be in use.)
  • Ability to lie still for PET scanning
  • Ability to provide written informed consent

Exclusion criteria

  • Age less than 18 years
  • Inability to lie still for PET scanning
  • Inability provide written informed consent
  • Currently undergoing chemotherapy for organ confined or systemic disease. This does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting.

Treatment and study plan

FACBC PET-CT

Drug

Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.

Other names: Fluciclovine

MRI, CT, or Bone Scan

Other

Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.

Primary outcomes

  1. Percent Change Assessed by FACBC PET Scan

    Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)

    Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells.

  2. Prostate Specific Antigen Level

    Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)

    Prostate Specific Antigen (PSA) serum biomarker will be used to assess response to treatment. PSA level will be collected via blood draw. While a formal cutpoint signifying prostate cancer is not generally used as PSA levels vary between men, in general, higher PSA levels indicate prostate cancer.

  3. Number of Participants Responding to Treatment Assessed by MRI

    Time frame: Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)

    Participants will have an MRI or a CT scan to assess response to treatment. Treatment response will be reported as follows:

    • Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
    • Complete Response Unknown (CRU)
    • Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
    • Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
    • Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.

  4. Number of Participants Responding to Treatment Assessed by CT Scan

    Time frame: After Cycle 6 (Week 17)

    A CT will be used to assess response to treatment. Treatment response will be reported as follows:

    • Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
    • Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
    • Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
    • Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.

  5. Number of Participants With a Clinical Response Assessed by Bone Scan

    Time frame: Baseline, After Cycle 6 (Week 17)

    Each patient underwent 99mTc MDP whole body bone scanning at baseline, and after the 6th cycle. Bone scans findings were interpreted based on recommendations from Prostate Cancer Clinical Trial Working Group 3 (PCCTWG3) using a specialized Bone Scan Assessment Tool. The change in disease response after cycle 6 compared to the baseline assessment is presented here.

Secondary outcomes

  1. Number of Deaths

    Time frame: End of Study (up to 1 year)

    The number of deaths that have occurred was assessed at the end of study.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Blue Earth Diagnostics
  • Nihon Medi-Physics Co., Ltd.

Registry information

Official study title

Investigation of Therapy Response With Amino Acid Analogue Transport PET Imaging

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jul 13, 2016
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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