Status:
UNKNOWN
68Ga-PSMA PET-CT Scan for Diagnosis and Management of Prostate Cancer
Lead Sponsor:
Ebrahim Delpassand
Collaborating Sponsors:
Radiomedix, Inc.
Excel Diagnostics and Nuclear Oncology Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II clinical trial study to show how well the 68Ga-PSMA-11 (ProstaMedix™) PET-CT scan works in detecting tumor location and size in patients with suspected or confirmed prostate cancer,...
Detailed Description
68Ga-PSMA-11 is a radioactive imaging contrast agent for use in PET CT scan that seeks to identify prostate cancer cells that have a specific protein target called prostate-specific membrane antigen (...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- General requirements:
- Karnofsky performance status of ≥50 (or ECOG/WHO equivalent).
- Age \> 18 years .
- Ability to understand a written informed consent document, and the willingness to sign it.
- i. inclusion criteria specific for the pre-prostatectomy group:
- 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).
- 4\. ii. inclusion criteria specific for biochemical recurrence group:
- Histopathological proven prostate adenocarcinoma.
- Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Post radical prostatectomy (RP) - AUA recommendation, PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
- Post-radiation therapy -ASTRO-Phoenix consensus definition, Nadir + greater than or equal to 2 ng/mL rise in PSA 5. Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET
- Exclusion Criteria
- General requirements:
- Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
- Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criterion 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).
- i. Exclusion criteria specific for the pre-prostatectomy group: Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu) within the last 2 months.
- 3\. ii. Exclusion criteria specific for biochemical recurrence group:
- Investigational therapy for prostate cancer for less than 2 months.
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT02282137
Start Date
May 1 2015
End Date
December 1 2023
Last Update
August 19 2020
Active Locations (1)
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1
Radio- Isotope Therapy of America
Houston, Texas, United States, 77042