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NCT Number: NCT05141760

18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients

This prospective phase II study assesses the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007)) and multiparametric magnetic resonance imaging (MRI) for locoregional staging of clinically significant prostate cancer in men undergoing radical prostatectomy and bilateral pelvic lymph node dissection. The design will be a multicenter validating-paired cohort study using radical prostatectomy and pelvic lymph node dissection as the gold standard comparator. Each patient will undergo both 18F-PSMA-1007 PET and 3T MRI allowing comparison of each imaging modality within each subject. Furthermore, PET and MRI will be compared to standard-of-care imaging techniques (CT abdomen/pelvis and 99mTc-MDP Bone scan).

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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

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients or their legal medical decision makers will sign an informed consent prior to entering the study.
  • Adult patient (≥ 18 years old) with a diagnosis of at least Gleason Grade Group 2 prostate cancer.
  • Appropriate staging investigations have been performed prior to the participation in the study (i.e. CT abdomen/pelvis and 99mTc-MDP bone scan)

Exclusion criteria

  • Unable to obtain consent
  • Weight >250 kg (weight limitation of scanners)
  • Unable to lie flat for 30 minutes to complete the PET or MRI imaging
  • Severe claustrophobia precluding image acquisition
  • Lack of intravenous access
  • Non-MRI compatible pacemaker or hardware
  • eGFR < 40 mL/min/1.73 m2 and/or a history of a severe reaction to MRI contrast
  • Prior androgen deprivation therapy

Treatment and study plan

PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)

Diagnostic Test

Additional staging PET and MRI scan prior to prostatectomy and lymph node dissection

Primary outcomes

  1. Tumor T-staging

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b)

Secondary outcomes

  1. Sensitivity of PSMA-1007 PET

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Compare final histology against PSMA-1007 PET

  2. Sensitivity of MRI

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Compare final histology against MR imaging

  3. Specificity of PSMA-1007 PET

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Compare final histology against PSMA-1007 PET

  4. Specificity of MRI

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Compare final histology against MR imaging

  5. Negative Predictive Value of PSMA-1007 PET

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Compare final histology against PSMA-1007 PET

  6. Negative Predictive Value of MRI

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Compare final histology against MR imaging

  7. Positive Predictive Value of PSMA-1007 PET

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Compare final histology against PSMA-1007 PET

  8. Positive Predictive Value of MRI

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Compare final histology against MRI

  9. Nodal Staging

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Accuracy of nodal disease on PSMA-1007 PET and MRI compared to bone scan + CT

  10. Metastatic Staging

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Accuracy of PSMA-1007 PET and MRI compared to bone scan + CT

  11. Longest Tumor diameter

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Compare final histology against PSMA-1007 PET and MRI measurements

  12. Identification of dominant lesion

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Compare rate of dominant lesion identification of PSMA-1007 PET and MRI against final histology

  13. Identification of non-dominant lesion

    Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging

    Compare rate of non-dominant lesion identification of PSMA-1007 PET and MRI against final histology

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Urological Association Scholarship Foundation

Registry information

Official study title

Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2021
Registry last updated
Jun 6, 2024

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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