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Research ArticleOncology

Phase 2 Study of 99mTc-Trofolastat SPECT/CT to Identify and Localize Prostate Cancer in Intermediate- and High-Risk Patients Undergoing Radical Prostatectomy and Extended Pelvic LN Dissection

Karolien E. Goffin, Steven Joniau, Peter Tenke, Kevin Slawin, Eric A. Klein, Nancy Stambler, Thomas Strack, John Babich, Thomas Armor and Vivien Wong
Journal of Nuclear Medicine September 2017, 58 (9) 1408-1413; DOI: https://doi.org/10.2967/jnumed.116.187807
Karolien E. Goffin
1Nuclear Medicine, UZ Leuven, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium
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Steven Joniau
2Urology, UZ Leuven, Department of Development and Regeneration, KU Leuven, Leuven, Belgium
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Peter Tenke
3Jahn Ferenc South Pest Hospital, Budapest, Hungary
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Kevin Slawin
4University of Texas Vanguard Urologic Institute, Houston, Texas
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Eric A. Klein
5Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio
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Nancy Stambler
6Progenics Pharmaceuticals, New York, New York; and
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Thomas Strack
6Progenics Pharmaceuticals, New York, New York; and
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John Babich
7Weill Cornell Medicine, New York, New York
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Thomas Armor
6Progenics Pharmaceuticals, New York, New York; and
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Vivien Wong
6Progenics Pharmaceuticals, New York, New York; and
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  • FIGURE 1.
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    FIGURE 1.

    Examples of fused axial 99mTc-trofolastat SPECT/CT reconstructions from previously acquired healthy volunteer (first column) and 3 study patients (top row), and matching axial contrast-enhanced T1-weighted MR images (bottom row) arranged by GS from left to right. Red arrowheads indicate location of histologically confirmed primary prostate lesions.

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    FIGURE 2.

    Box-and-whisker plots of mean reader scores (top row, ○) and TBR values (bottom row, ●) in prostate lobes: without PCa and with PCa (A); with GS ≤ 6 and GS ≥ 7 (B). Box and whiskers represent mean and interquartile range.

  • FIGURE 3.
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    FIGURE 3.

    ROC analyses curves and 95% confidence intervals (white area) of semiquantitative scoring system (A) and TBR (B) for detection of any grade PCa and semiquantitative scoring system (C) and TBR (D) for detection of GS ≥ 7 (3 + 4).

  • FIGURE 4.
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    FIGURE 4.

    Box-and-whisker plots of mean reader scores (top row, ○) and TBR values (bottom row, ●) in lobes with no PCa and in lobes with PCa of increasing GS.

  • FIGURE 5.
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    FIGURE 5.

    ROC analysis curves and 95% confidence intervals (white area) of TBR of prostate lesion using a TBR cutoff of 30.2 to predict presence of LNI. Maximal AUC is 0.77, yielding a sensitivity of 90% and a specificity of 67%.

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    TABLE 1

    Baseline Characteristics of Study Population

    CharacteristicValue
    Mean age (y)63.2 (range, 46–77)
    Clinical T-stage (n)
     T1c1 (1)
     T22 (1.9)
     T2a7 (6.7)
     T2b32 (30.5)
     T2c20 (19)
     T34 (3.8)
     T3a29 (27.6)
     T3b10 (9.5)
    Race (n)
     White102 (97.1)
     Black2 (1.9)
     Asian1 (1)
    Mean prostate-specific antigen (ng/mL)27.0 (range, 2.4–372.7)
    Prostate-specific antigen (n)
     ≤2068 (65)
     236 (35)
    Mean GS8 (range, 6–9)
    Biopsy GS (n)
     ≤65 (5)
     741 (39)
     ≥859 (56)
    Enrollment patients (n)
     United States40 (38)
     Europe65 (63)
    Ongoing ADT (n)20
    • Data in parentheses are percentages unless otherwise indicated.

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Journal of Nuclear Medicine: 58 (9)
Journal of Nuclear Medicine
Vol. 58, Issue 9
September 1, 2017
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Phase 2 Study of 99mTc-Trofolastat SPECT/CT to Identify and Localize Prostate Cancer in Intermediate- and High-Risk Patients Undergoing Radical Prostatectomy and Extended Pelvic LN Dissection
Karolien E. Goffin, Steven Joniau, Peter Tenke, Kevin Slawin, Eric A. Klein, Nancy Stambler, Thomas Strack, John Babich, Thomas Armor, Vivien Wong
Journal of Nuclear Medicine Sep 2017, 58 (9) 1408-1413; DOI: 10.2967/jnumed.116.187807

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Phase 2 Study of 99mTc-Trofolastat SPECT/CT to Identify and Localize Prostate Cancer in Intermediate- and High-Risk Patients Undergoing Radical Prostatectomy and Extended Pelvic LN Dissection
Karolien E. Goffin, Steven Joniau, Peter Tenke, Kevin Slawin, Eric A. Klein, Nancy Stambler, Thomas Strack, John Babich, Thomas Armor, Vivien Wong
Journal of Nuclear Medicine Sep 2017, 58 (9) 1408-1413; DOI: 10.2967/jnumed.116.187807
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Keywords

  • 99mTc-trofolastat (99mTc-MIP-1404)
  • SPECT/CT
  • prostate cancer
  • histopathology
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