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Completed

NCT Number: NCT02918357

Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

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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 / Phase 3

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histopathological proven prostate adenocarcinoma.
  • Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
  • Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
  • PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
  • Confirmatory persistent PSA greater than 0.2 ng/mL
  • Post-radiation therapy -ASTRO-Phoenix consensus definition
  • Nadir + greater than or equal to 2 ng/mL rise in PSA
  • Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
  • Age > 18.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

  • Investigational therapy for prostate cancer.
  • Unable to lie flat, still or tolerate a PET scan.
  • Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
  • Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).

Treatment and study plan

Ga-68 labeled PSMA-11 PET

Drug

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

Other names: Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED-CC, Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC, Ga-68 labeled HBED-CC PSMA

Primary outcomes

  1. Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation

    Time frame: 1 month

    PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.

  2. Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation

    Time frame: 1 month

    PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.

Secondary outcomes

  1. PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up

    Time frame: 1 month

    PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.

  2. PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up

    Time frame: 1 month

    PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.

  3. Sensitivity on a Per-patient Basis

    Time frame: 1 month

    Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.

  4. Sensitivity on a Per-region Basis

    Time frame: 1 month

    Sensitivity, on a per-region basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.

  5. Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value

    Time frame: 1 month

    Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-<0.5; 0.5-<1.0; 1.0-<2.0; 2.0-<5.0, and ≥5.0).

  6. Inter-reader Agreement Per-region

    Time frame: 1 month

    Inter-reader reproducibility for positivity at region level was reported using the Fleiss' Kappa test for multiple readers. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).

  7. Percentage of Participants With Change in Clinical Management

    Time frame: Up to 1 year

    Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET.

  8. Safety Assessment - Heart Rate

    Time frame: 1 day

    Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.

  9. Safety Assessment - Blood Pressure

    Time frame: 1 day

    Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: PSMA BCR

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2016
Registry last updated
Dec 2, 2019

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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