68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/16/2019 |
| Start Date: | May 20, 2017 |
| End Date: | August 2021 |
68Ga-PSMA PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA
This trial studies how well gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC
(68Ga-PSMA) positron emission tomography (PET)/computed tomography (CT) works in detecting
prostate cancer that may have come back in patients with elevated prostate-specific antigen
(PSA) after initial treatment. A rise in blood level of PSA, a protein made by the prostate,
after treatment with surgery or radiation in patients without symptoms indicates that the
cancer may have come back (recurrence). PSA however cannot determine whether the disease is
located only in the prostate or other places in the body. 68Ga-PSMA is a radioactive tracer
that targets and specifically binds to tumor cells expressing PSA making them lighting up.
PET and CT make computerizing pictures of areas inside the body where the radioactive
substance is lighting up. 68Ga-PSMA PET/CT may be able to see smaller tumors than standard
imaging and may help determine whether prostate cancer has come back and where it is in the
body.
(68Ga-PSMA) positron emission tomography (PET)/computed tomography (CT) works in detecting
prostate cancer that may have come back in patients with elevated prostate-specific antigen
(PSA) after initial treatment. A rise in blood level of PSA, a protein made by the prostate,
after treatment with surgery or radiation in patients without symptoms indicates that the
cancer may have come back (recurrence). PSA however cannot determine whether the disease is
located only in the prostate or other places in the body. 68Ga-PSMA is a radioactive tracer
that targets and specifically binds to tumor cells expressing PSA making them lighting up.
PET and CT make computerizing pictures of areas inside the body where the radioactive
substance is lighting up. 68Ga-PSMA PET/CT may be able to see smaller tumors than standard
imaging and may help determine whether prostate cancer has come back and where it is in the
body.
PRIMARY OBJECTIVES:
I. To evaluate 68Ga-PSMA PET/CT for detection of recurrent prostate cancer after initial
therapy in patients with elevated PSA.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC intravenously
(IV). Beginning 45-60 minutes later, patients under whole body (skull base to mid-thighs)
PET/CT scan.
After completion of study procedure, patients are followed up every 12-24 weeks for 12
months.
I. To evaluate 68Ga-PSMA PET/CT for detection of recurrent prostate cancer after initial
therapy in patients with elevated PSA.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC intravenously
(IV). Beginning 45-60 minutes later, patients under whole body (skull base to mid-thighs)
PET/CT scan.
After completion of study procedure, patients are followed up every 12-24 weeks for 12
months.
Inclusion Criteria:
- Histopathological proven prostate adenocarcinoma
- Rising 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 6-13 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
- Able to provide written consent
- Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group
[ECOG]/World Health Organization [WHO] equivalent)
Exclusion Criteria:
- Investigational therapy for prostate cancer.
- 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).
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Andrei Iagaru, MD
Phone: 650-725-6409
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