Status:
WITHDRAWN
68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer
Lead Sponsor:
Dana Mathews
Conditions:
Prostate Cancer
Prostate Cancer Metastatic
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The goal of this research is to examine the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to detect sites of re...
Detailed Description
In developed countries, prostate cancer is the most common malignancy in men and the third leading cause of death in men. Following primary therapy for prostate cancer, a substantial number of patient...
Eligibility Criteria
Inclusion
- Patients with suspected BCR of prostate cancer following initial treatment with either prostatectomy or definitive EBRT of the prostate or patients with known metastatic prostate cancer who have failed systemic therapy.
- Patients being considered for salvage therapy.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Patients must be medically stable as judged by the patient's physician.
- Patients must be able to lie still for 20-40 minutes for the PET/CT scans.
- Ability to understand and the willingness to sign a written informed consent.
- Patients with BCR and no known lesions should not be on antiandrogen therapy at the time of scans. Patients with known metastases who are currently being treated with anti-androgen therapy may remain on this medication.
Exclusion
- Patients who have or have had a biopsy proven concurrent other malignancy, excluding skin cancers.
- Patients may not weigh more than the maximum weight limit for the PET /CT scanner table (\> 200 kg or 440 pounds).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11. Furosemide will not be administered to patients with known allergy.
- Patients must not be claustrophobic.
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04483414
Start Date
March 19 2021
End Date
April 5 2023
Last Update
May 19 2023
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390