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

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ClinicalTrials.gov Identifier: NCT03762759
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : January 21, 2019
Sponsor:
Collaborator:
Telix International Pty Ltd
Information provided by (Responsible Party):
Ashesh B Jani, MD, Emory University

Tracking Information
First Submitted Date  ICMJE November 27, 2018
First Posted Date  ICMJE December 4, 2018
Last Update Posted Date January 21, 2019
Estimated Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03762759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes
Official Title  ICMJE Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes
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.
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 30 minutes.

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

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Adenocarcinoma
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Arm I (fluciclovine F18, PET/CT)
    Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
    Interventions:
    • Procedure: Computed Tomography
    • Drug: Fluciclovine F18
    • Procedure: Positron Emission Tomography
  • 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.
    Interventions:
    • Procedure: Computed Tomography
    • Radiation: Gallium Ga68-labeled PSMA-11
    • Procedure: Positron Emission Tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2018)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ashesh Jani, MD, MSEE 404-778-3827 abjani@emory.edu
Contact: David Schuster, MD 404-712-4859 dschust@emory.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03762759
Other Study ID Numbers  ICMJE IRB00106863
NCI-2018-02702 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RAD4516-18 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ashesh B Jani, MD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Telix International Pty Ltd
Investigators  ICMJE
Principal Investigator: Ashesh Jani, MD, MSEE Emory University
PRS Account Emory University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP