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

Prostate Cancer Clinical Trial

— PSMA BCR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918357
• Other study ID #: 165510
• Secondary ID: NCI-2018-00039
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 15, 2016
• Est. completion date: September 21, 2017

Study information

• Verified date: November 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: September 21, 2017
• Est. primary completion date: September 21, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Recurrence

Intervention

Drug:
• Ga-68 labeled PSMA-11 PET
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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Primary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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).	1 month
Secondary	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).	1 month
Secondary	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.	Up to 1 year
Secondary	Safety Assessment - Heart Rate	Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.	1 day
Secondary	Safety Assessment - Blood Pressure	Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.	1 day