PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ga-68 PSMA11
F-18 PSMA 1007
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, PET/CT, PSMA, C-11 Choline
Eligibility Criteria
Inclusion Criteria:
- Histopathological proven prostate adenocarcinoma.
Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. > 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies)
- Karnofsky performance status of 50 (or ECOG/WHO equivalent).
- CT or as part of the PET study or performed within one month of PSMA PET.
- Age > 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
- Undergoing investigational therapy for prostate cancer.
- Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy or androgen deprivation. Androgen deprivation within the last 4 months excluding finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate resistant subjects).
- 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).
- Absence of PSA and total testosterone tests within 4 weeks.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PET/CT Ga-68 PSMA
PET/CT F-18 Labeled PSMA 1007
Arm Description
Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT
F-18 Labeled PSMA 1007 PET/CT
Outcomes
Primary Outcome Measures
Tumor Detection on PET/CT
Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.
Secondary Outcome Measures
Impact of PSMA and C-11 choline PET on clinical management
Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management
Incidence of adverse events attributable to PSMA
Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03768349
Brief Title
PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
Official Title
PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
February 3, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
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
Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, PET/CT, PSMA, C-11 Choline
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/CT Ga-68 PSMA
Arm Type
Experimental
Arm Description
Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT
Arm Title
PET/CT F-18 Labeled PSMA 1007
Arm Type
Experimental
Arm Description
F-18 Labeled PSMA 1007 PET/CT
Intervention Type
Drug
Intervention Name(s)
Ga-68 PSMA11
Intervention Description
Ga-68 PSMA11 PET/CT for detection of tumor location
Intervention Type
Drug
Intervention Name(s)
F-18 PSMA 1007
Intervention Description
F-18 PSMA 1007 PET/CT for detection of tumor location
Primary Outcome Measure Information:
Title
Tumor Detection on PET/CT
Description
Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.
Time Frame
12 Months post PET/CT
Secondary Outcome Measure Information:
Title
Impact of PSMA and C-11 choline PET on clinical management
Description
Descriptive statistics will be used to evaluate the impact of PSMA and C-11 choline PET on clinical management
Time Frame
12 Months
Title
Incidence of adverse events attributable to PSMA
Description
Adverse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Time Frame
12 Months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histopathological proven prostate adenocarcinoma.
Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. > 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies)
Karnofsky performance status of 50 (or ECOG/WHO equivalent).
CT or as part of the PET study or performed within one month of PSMA PET.
Age > 18.
Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
Undergoing investigational therapy for prostate cancer.
Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy or androgen deprivation. Androgen deprivation within the last 4 months excluding finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate resistant subjects).
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).
Absence of PSA and total testosterone tests within 4 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Val Lowe, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The IPD data from this trial will be available to other researchers that will collate similar data from multiple sites to provide data to the FDA.
IPD Sharing Time Frame
After completion of the trial and IPD will be available for 2 years.
IPD Sharing Access Criteria
Researchers collating data from multiple sites for submission to the FDA will be provided access to the IPD.
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
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