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NCT Number: NCT05948657

Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr

This study will be assessing the ability of PSMA-PET CT to determine the absence of clinically significant prostate cancer in patients on active surveillance (AS) with low risk and favorable intermediate-risk prostate cancer.

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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

Not applicable

Primary location

UCLA, Los Angeles, California, United States

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About this study

This is a prospective, multicenter, nonrandomized single-arm study assessing the diagnostic accuracy of PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) in determining the absence of clinically significant prostate cancer in patients on active surveillance (AS).The trial will enroll 200 subjects for low and favorable intermediate-risk prostate cancer patients per NCCN guidelines who have elected to pursue active surveillance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males aged ≥ 18.
  • Histologically confirmed low or favorable intermediate risk prostate cancer per NCCN guidelines. (Note: Grade Group 2 must have 20% or less involvement in every core and no presence of cribiform or intraductal carcinoma).
  • PSA < 20 ng/ml.
  • Ability to undergo yearly PSMA-PET CT.
  • Ability to undergo yearly prostate mpMRI.
  • Ability to undergo transrectal or transperineal template and fusion prostate biopsy.
  • Willingness to undergo yearly prostate biopsies.

Exclusion criteria

  • History of prior treatment for prostate cancer.
  • History of systemic therapy for prostate cancer.
  • Inability to undergo transrectal ultrasound.
  • Life expectancy less than 10 years.
  • Not interested in pursuing active surveillance.
  • Initial diagnosis of prostate cancer greater than 15 months.

Treatment and study plan

PSMA-PET CT

Diagnostic Test

Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.

Primary outcomes

  1. Negative predictive value (NPV)

    Time frame: Baseline

    Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.

  2. Negative predictive value (NPV)

    Time frame: 12 months

    Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.

  3. Negative predictive value (NPV)

    Time frame: 24 months

    Negative predictive value (NPV): The NPV is defined as the number of negative image results with identified clinically insignificant prostate cancer on biopsy divided by the number of negative image results.

Secondary outcomes

  1. Positive predictive value (PPV) of PSMA PET.

    Time frame: Baseline

    PPV of PSMA PET. Positive predictive value (PPV): The PPV is defined as the number of positive image results with identified csPCa on biopsy divided by the number of positive image results.

  2. Positive predictive value (PPV) of PSMA PET.

    Time frame: 12 months

    PPV of PSMA PET. Positive predictive value (PPV): The PPV is defined as the number of positive image results with identified csPCa on biopsy divided by the number of positive image results.

  3. Positive predictive value (PPV) of PSMA PET.

    Time frame: 24 months

    PPV of PSMA PET. Positive predictive value (PPV): The PPV is defined as the number of positive image results with identified csPCa on biopsy divided by the number of positive image results.

  4. Number of patients with negative PSMA pet scan.

    Time frame: Baseline

  5. Number of patients with negative PSMA pet scan.

    Time frame: 12 months

  6. Number of patients with negative PSMA pet scan.

    Time frame: 24 months

  7. Number of positive scans on mpMRI

    Time frame: Baseline

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.

  8. Number of positive scans on mpMRI

    Time frame: 12 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.

  9. Number of positive scans on mpMRI

    Time frame: 24 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.

  10. Number of positive scans on PSMA-PET

    Time frame: Baseline

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.

  11. Number of positive scans on PSMA-PET

    Time frame: 12 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.

  12. Number of positive scans on PSMA-PET

    Time frame: 24 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.

  13. Number of positive scans on both PSMA-PET and mpMRI

    Time frame: Baseline

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.

  14. Number of positive scans on both PSMA-PET and mpMRI

    Time frame: 12 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.

  15. Number of positive scans on both PSMA-PET and mpMRI

    Time frame: 24 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Sensitivity: The sensitivity will be defined as the number of positive image results with a csPCa upon biopsy divided by the number of biopsied patients with csPCa following the imaging.

  16. Number of negative scans on mpMRI

    Time frame: Baseline

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.

  17. Number of negative scans on mpMRI

    Time frame: 12 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.

  18. Number of negative scans on mpMRI

    Time frame: 24 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.

  19. Number of negative scans on PSMA-PET

    Time frame: Baseline

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.

  20. Number of negative scans on PSMA-PET

    Time frame: 12 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.

  21. Number of negative scans on PSMA-PET

    Time frame: 24 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.

  22. Number of negative scans on both PSMA-PET and mpMRI

    Time frame: Baseline

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.

  23. Number of negative scans on both PSMA-PET and mpMRI

    Time frame: 12 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.

  24. Number of negative scans on both PSMA-PET and mpMRI

    Time frame: 24 months

    Specificity and sensitivity of PSMA-PET, mpMRI, and the combination.

    Specificity: The specificity is defined as the number of negative image results followed by the absence of csPCa in the corresponding biopsy divided by the number of biopsies that did not identify csPCa.

  25. Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.

    Time frame: Baseline

    The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.

  26. Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.

    Time frame: 12 months

    The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.

  27. Number of patients who have clinically significant Prostate Cancer (csPCa) detected by PSMA-PET.

    Time frame: 24 months

    The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.

  28. Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.

    Time frame: Baseline

    The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.

  29. Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.

    Time frame: 12 months

    The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.

  30. Number of patients who have clinically significant Prostate Cancer (csPCa) detected by mpMRI.

    Time frame: 24 months

    The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.

  31. Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.

    Time frame: Baseline

    The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.

  32. Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.

    Time frame: 12 months

    The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.

  33. Number of patients who have clinically significant Prostate Cancer (csPCa) detected on PSMA-PET and mpMRI.

    Time frame: 24 months

    The proportion of csPCa detected by PSMA-PET, mpMRI, and the combination. Proportion of patients with csPCa: this will be the number of patients identified as having csPCa divided by the number of patients with a biopsy.

Study contacts

Contact information is provided by the study sponsor or research team.

Holly Kuczynski

CONTACT

[email protected]

646-962-7523

Sarah Yuan

CONTACT

[email protected]

646-962-6040

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

ESCAPE - Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr

Acronym: ESCAPE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2023
Registry last updated
May 4, 2026

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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