Prostate Cancer Clinical Trial
68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment
Summary
The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.
Full Description
PRIMARY OBJECTIVES:
I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen.
Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.
Eligibility Criteria
Inclusion Criteria:
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) - American Urology Association (AUA) recommendation
PSA greater than 0.2 ng/mL measured 6 to 13 weeks after RP
Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition
A rise of PSA measurement of 2 or more ng/mL over the nadir
Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group [ECOG] / World Health Organization [WHO] equivalent)
Able to provide written consent
Exclusion Criteria:
Investigational therapy for prostate cancer.
Unable to lie flat, still or tolerate a positron emission tomograpy (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.
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There is 1 Location for this study
Palo Alto California, 94304, United States
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