Gallium-68 PSMA-11 PET Imaging in Patients With Biochemical Recurrence
Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence
Sponsors
Source
University of California, San Francisco
Oversight Info
Has Dmc
Yes
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 its ability to detection prostate cancer in patients
with biochemical recurrence after prostatectomy and radiation therapy.
Overall Status
Active, not recruiting
Start Date
2017-09-20
Completion Date
2020-09-01
Primary Completion Date
2020-09-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Sensitivity on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in prostate bed confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. |
1 day |
|
Sensitivity on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in pelvis outside of prostate bed including lymph nodes confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. |
1 Day |
|
Sensitivity on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in extrapelvic soft tissue, lymph nodes and organ metastases (non-bone) confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. |
1 Day |
|
Sensitivity on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in bone metastases confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. |
1 Day |
Secondary Outcome
Measure |
Time Frame |
|
Positive predictive value (PPV) for detection of tumor location in prostate bed confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. |
1 Day |
|
PPV for detection of tumor location in pelvis outside of prostate bed including lymph nodes confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. |
1 Day |
|
PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in extrapelvic soft tissue, lymph nodes and organ metastases (non-bone) confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. |
1 Day |
|
PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location in bone metastases confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. |
1 Day |
|
Detection rates of 68Ga-PSMA-11 PET stratified by PSA value |
1 Day |
|
Impact of 68Ga-PSMA-11 PET on clinical management in patients with biochemical recurrence (BCR) |
Up to 6 months |
|
Inter-reader reproducibility for positivity |
1 Day |
Enrollment
345
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 prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after
definitive therapy with prostatectomy or radiation therapy (external beam or
brachytherapy).
- Post radical prostatectomy (RP) - American Urological Association (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 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
- 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 |
|
Thomas Hope, MD |
Principal Investigator |
University of California, San Francisco |
Location
Facility |
|
University of California, San Francisco San Francisco California 94143 United States |
Location Countries
Country
United States
Verification Date
2019-09-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor-Investigator
Investigator Affiliation
University of California, San Francisco
Investigator Full Name
Thomas Hope
Investigator Title
Assistant Professor
Has Expanded Access
No
Condition Browse
Secondary Id
NCI-2018-00040
Number Of Arms
1
Intervention Browse
Mesh Term
Edetic Acid
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
Patient Data
Sharing Ipd
No
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
September 30, 2019
Last Update Submitted Qc
September 30, 2019
Last Update Posted
October 1, 2019
ClinicalTrials.gov processed this data on December 06, 2019
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.