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Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence (PSMA BCR)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ga-68 labeled PSMA-11 PET
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ga-68 labeled PSMA-11 PET

Arm Description

PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Outcomes

Primary Outcome Measures

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

PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
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.
PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
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.
Sensitivity on a Per-patient Basis
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.
Sensitivity on a Per-region Basis
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.
Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value
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).
Inter-reader Agreement Per-region
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).
Percentage of Participants With Change in Clinical Management
Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET.
Safety Assessment - Heart Rate
Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.
Safety Assessment - Blood Pressure
Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.

Full Information

First Posted
September 27, 2016
Last Updated
November 27, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02918357
Brief Title
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Acronym
PSMA BCR
Official Title
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 15, 2016 (Actual)
Primary Completion Date
September 21, 2017 (Actual)
Study Completion Date
September 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ga-68 labeled PSMA-11 PET
Arm Type
Experimental
Arm Description
PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
Intervention Type
Drug
Intervention Name(s)
Ga-68 labeled PSMA-11 PET
Other Intervention Name(s)
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
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation
Description
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.
Time Frame
1 month
Title
Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
Description
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.
Time Frame
1 month
Title
PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
Description
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.
Time Frame
1 month
Title
Sensitivity on a Per-patient Basis
Description
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.
Time Frame
1 month
Title
Sensitivity on a Per-region Basis
Description
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.
Time Frame
1 month
Title
Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value
Description
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).
Time Frame
1 month
Title
Inter-reader Agreement Per-region
Description
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).
Time Frame
1 month
Title
Percentage of Participants With Change in Clinical Management
Description
Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET.
Time Frame
Up to 1 year
Title
Safety Assessment - Heart Rate
Description
Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.
Time Frame
1 day
Title
Safety Assessment - Blood Pressure
Description
Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.
Time Frame
1 day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hope, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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