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Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762759
Recruitment Status : Active, not recruiting
First Posted : December 4, 2018
Last Update Posted : May 6, 2023
Sponsor:
Collaborators:
Telix International Pty Ltd
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ashesh B Jani, Emory University

Study Description
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Brief Summary:
This phase II trial studies how well a positron emission tomography (PET)/computed tomography (CT) scan using fluciclovine F18 compared with a PET/CT scan with 68Ga-PSMA works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. Fluciclovine F18 and 68Ga-PSMA are types of tracers, called radiotracers, that are injected and can accumulate in tumor cells to develop images of them during a PET/CT scan. It is not yet known whether giving fluciclovine F18 or 68Ga-PSMA may work better in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Procedure: Computed Tomography Drug: Fluciclovine F18 Radiation: Gallium Ga68-labeled PSMA-11 Procedure: Positron Emission Tomography Phase 2

Detailed Description:

PRIMARY OBJECTIVES

I. Improve the outcomes of post-prostatectomy radiotherapy prostate cancer patients via selection and treatment optimization with advanced molecular imaging with dose escalation.

II. Establish the role of advanced molecular imaging with fluciclovine F18 (fluciclovine [18F]) and gallium Ga68-labeled prostate specific membrane antigen PSMA-11 (68Ga-PSMA) PET/CT in influencing post-prostatectomy radiotherapy decision-making.

III. Establish the role of advanced molecular imaging with fluciclovine 18F or 68Ga-PSMA in altering radiotherapy treatment volumes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive fluciclovine F18 intravenously (IV) and undergo a PET/CT over approximately 30 minutes.

ARM II: Patients receive 68Ga-PSMA IV, wait 60 minutes, then undergo a PET/CT over approximately 30 minutes.

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (fluciclovine F18, PET/CT)
Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
 Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CT scan
  • Computerized axial tomography
  • CAT
  • CAT scan

Drug: Fluciclovine F18
Given IV
Other Names:
  • anti-3-[18F]FACBC
  • Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
  • FACBC
  • [18F]FACBC
  • Axumin

Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • PET
  • PET scan
  • Proton magnetic resonance spectroscopic imaging
Active Comparator: Arm II (68Ga-PSMA, PET/CT)
Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
 Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CT scan
  • Computerized axial tomography
  • CAT
  • CAT scan

Radiation: Gallium Ga68-labeled PSMA-11
Given IV
Other Names:
  • 68Ga-PSMA
  • 68Ga PSMA
  • [68Ga] Prostate-specific Membrane Antigen 11
  • 68Ga-DKFZ-PSMA-11
  • 68Ga-PSMA-HBED-CC

Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • PET
  • PET scan
  • Proton magnetic resonance spectroscopic imaging


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: Up to 2 years after study start ]
    A survival analysis will be conducted on disease-free survival (DFS). The survivor functions for DFS will be estimated with Kaplan and Meier method and plotted. The logrank test will be used to test the difference in DFS of (a) both arms in aggregate with the survivor function on our prior R01 trial and (b) between the two study arms.


Secondary Outcome Measures :
  1. Decision to offer radiotherapy [ Time Frame: Up to 5 years after study start ]
    Decision to offer radiotherapy or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.

  2. Decision to treat pelvic nodes [ Time Frame: Up to 5 years after study start ]
    Decision to provide treatment on pelvic nodes or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.

  3. Decision to boost between the initial and final treatment decisions [ Time Frame: Up to 5 years after study start ]
    Decision to boost or not between the initial (pre-fluciclovine F18 or 68Ga-PSMA) and final (post-fluciclovine F18 or 68Ga-PSMA) treatment decisions will be compared using the Clopper-Pearson (exact) binomial test.

  4. Prostate bed clinical target volume (CTV) and planning target volume (PTV) [ Time Frame: Up to 5 years after study start ]
    Paired t-test will be used to compare the target volumes (CTV and PTV) and the planned dose delivered to surrounding bladder, rectum, and penile bulb between the initial (pre-positron emission tomography [PET]) and final (post-PET) radiation treatment plans.

  5. PTV of the rectum (V65, V40) [ Time Frame: Up to 5 years after study start ]
    Spearman's correlation coefficient will be used to measure the correlations of the bladder and rectum dosimetric endpoints (V65, V40) with the grades (0, 1, 2, or 3) of acute genitourinary (GU) or gastrointestinal (GI) toxicity. A Wald test will be used to test the significance level of their correlations. A Cox model will be employed to assess the relationship between the time to late GU or GI toxicity (grade ≥ 2) and the bladder and rectum dosimetric endpoints (V65, V40), respectively.

  6. PTV of the bladder (V65, V40) [ Time Frame: Up to 5 years after study start ]
    Spearman's correlation coefficient will be used to measure the correlations of the bladder and rectum dosimetric endpoints (V65, V40) with the grades (0, 1, 2, or 3) of acute GU or GI toxicity. A Wald test will be used to test the significance level of their correlations. A Cox model will be employed to assess the relationship between the time to late GU or GI toxicity (grade ≥ 2) and the bladder and rectum dosimetric endpoints (V65, V40), respectively.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adenocarcinoma of the prostate, post radical-prostatectomy
  • Detectable prostate-specific antigen (PSA)
  • Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
  • No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan
  • No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of abdomen and pelvis
  • Willingness to undergo pelvic radiotherapy

Exclusion Criteria:

  • Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy)
  • Inability to undergo fluciclovine or Ga-PSMA PET-CT
  • Definitive findings of systemic metastasis on conventional imaging or biopsy
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years

  • Severe acute co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients
Contacts and Locations
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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): NCT03762759


Locations
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United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Emory University
Telix International Pty Ltd
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Ashesh Jani, MD, MSEE Emory University
  Study Documents (Full-Text)

Documents provided by Ashesh B Jani, Emory University:
Informed Consent Form  [PDF] October 17, 2022

More Information
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Responsible Party: Ashesh B Jani, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT03762759    
Other Study ID Numbers: IRB00106863
NCI-2018-02702 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RAD4516-18 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
R01CA226992 ( U.S. NIH Grant/Contract )
P30CA138292 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Gallium 68 PSMA-11
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action