Gallium-68 PSMA-11 PET Imaging in Patients With Biochemical Recurrence
Gallium-68 PSMA-11 PET Imaging in Patients With Biochemical Recurrence
Sponsors
Source
University of California, San Francisco
Oversight Info
Is Fda Regulated Drug
Yes
Is Fda Regulated Device
No
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.
Overall Status
Recruiting
Start Date
2017-10-01
Completion Date
2019-12-01
Primary Completion Date
2019-12-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Sensitivity on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. |
12 months |
Enrollment
500
Condition
Intervention
Intervention Type
Drug
Intervention Name
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.
Arm Group Label
Ga-68 labeled PSMA-11 PET
Other Name
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
Eligibility
Criteria
Inclusion Criteria
- Histopathologically proven prostate adenocarcinoma.
- Rising PSA (at least two consecutive rising PSAs) after definitive therapy with
prostatectomy or radiation therapy (external beam or brachytherapy).
- Post radical prostatectomy (RP) - AUA recommendation for biochemical recurrence
after radical prostatectomy
- PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
- Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical
recurrence after radiation therapy
- Nadir + greater than or equal to 2 ng/mL rise in PSA
- Karnofsky performance status of > 50 (or ECOG/WHO equivalent).
- Age > 18.
- Ability to understand a written informed consent document, and the willingness to sign
it.
Exclusion Criteria
- Unable to lie flat, still or tolerate a PET scan.
- Concomitant investigational therapy.
- Patient undergoing active treatment for non-prostate malignancy, 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).
Gender
Male
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Thomans Hope, MD |
Principal Investigator |
University of California, San Francisco |
Location
Facility |
Status |
Contact |
Investigator |
|
UCSF Imaging Center at China Basin San Francisco California 94107 United States |
Recruiting |
Last Name: Thomas Hope, MD Role: Principal Investigator |
Location Countries
Country
United States
Verification Date
2018-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
Ga-68 labeled PSMA-11 PET
Arm Group Type
Experimental
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.
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)
Study First Submitted
November 21, 2017
Study First Submitted Qc
November 21, 2017
Study First Posted
November 27, 2017
Last Update Submitted
July 24, 2018
Last Update Submitted Qc
July 24, 2018
Last Update Posted
July 26, 2018
ClinicalTrials.gov processed this data on August 31, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.