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Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients (PSMA PreRP)

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ClinicalTrials.gov Identifier: NCT02919111
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco

Study Description
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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 high risk disease prior to prostatectomy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Ga-68 labeled PSMA-11 PET Phase 2 Phase 3

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 pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis.

This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring Ga-68-PSMA-11 to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients
Actual Study Start Date : October 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Gallium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ga-68 labeled PSMA-11 PET
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.
 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.
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


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of PSMA PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis using nodal regional correlation. [ Time Frame: one month ]
    Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the sensitivity will be calculated with the corresponding 95% confidence interval.

  2. Specificity of PSMA PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis using nodal regional correlation. [ Time Frame: one month ]
    Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the specificity will be calculated with the corresponding 95% confidence interval.

  3. Positive Predictive Value of PSMA PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis using nodal regional correlation. [ Time Frame: one month ]
    Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the Positive Predictive Value will be calculated with the corresponding 95% confidence interval.

  4. Negative Predictive Value of PSMA PET for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis using nodal regional correlation. [ Time Frame: one month ]
    Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the Negative Predictive Value will be calculated with the corresponding 95% confidence interval.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven prostate adenocarcinoma.
  • Planned prostatectomy with lymph node dissection.
  • Intermediate to high-risk disease (as determined by elevated PSA [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors).
  • Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET.
  • Karnofsky performance status of greater than 50 (or ECOG/WHO equivalent).
  • Age > 18.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

  • Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
  • Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy.
  • Including focal ablation techniques (HiFu).
  • Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919111


Locations
United States, California
UCSF Imaging Center at China Basin Recruiting
San Francisco, California, United States, 94107
Contact: Raven Smith    415-353-9448    raven.smith@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
More Information
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Responsible Party: Thomas Hope, Assistant Professor of Radiology and Biomedical Imaging, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02919111     History of Changes
Other Study ID Numbers: 16559
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018