Status:
COMPLETED
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
Lead Sponsor:
University of Michigan
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Toget...
Detailed Description
This study evaluates Gallium-68 labelled PSMA-11 (also called Gallium-68 labelled PSMA-HBED-CC, or Gallium-68 labelled PSMA N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid), abbreviated he...
Eligibility Criteria
Inclusion
- Histopathological proven prostate adenocarcinoma.
- Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Post radical prostatectomy (RP) - according to American Urological Association (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.
- Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.
- Karnofsky performance status of ≥ 50.
- Age ≥ 18.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion
- Current investigational therapy for prostate cancer.
- Unable to lie flat, still or tolerate a PET/CT scan.
- Prior history of a malignancy within the last 2 years, except skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized, and except superficial bladder cancer.
- Prisoner.
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2022
Estimated Enrollment :
1435 Patients enrolled
Trial Details
Trial ID
NCT03396874
Start Date
February 9 2018
End Date
August 9 2022
Last Update
November 3 2023
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109