An Investigational Scan (68Ga PSMA-HBED-CC PET / CT Scan) in Imaging Patients with Biochemical Recurrence of Prostate Cancer
This phase IIb / III trial studies how well 68Ga PSMA-HBED-CC positron emission tomography (PET) / computed tomography (CT) scan works in imaging patients with prostate cancer that is suspected to have come back based on elevated levels of prostate specific antigen but might not be causing disease-related symptoms (biochemical recurrence). Diagnostic procedures, such as 68Ga PSMA-HBED-CC PET / CT, may help find and diagnose prostate cancer.
- Pathologically proven prostate adenocarcinoma
- Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy) * If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association [AUA] recommendation for biochemical recurrence) * If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society for Therapeutic Radiation and Oncology [ASTRO] recommendation for biochemical recurrence)
- A PSA level result within the last 2 months
- Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an investigational new drug [IND] for initial efficacy investigations)
- No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion)
- Karnofsky performance status (KPS) of >= 50 (Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] 0, 1, or 2) within the last 3 months
- Ability to understand and willingness to provide informed consent
- Cannot receive furosemide
- History of Stevens-Johnson syndrome
- History or diagnosis of Paget’s disease
- Malignancy other than current disease under study
- Allergy to sulfa or sulfa-containing medications
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Locations & Contacts
Contact: Michael M. Graham
Trial Objectives and Outline
I. Determine sensitivity on a per-subject and per-region basis of gallium 68-labeled prostate specific membrane antigen-11 N,N'-bis [2-hydroxy-5-(carboxyethyl)benzyl] ethylenediamine-N,N'-diacetic acid (68Ga PSMA-HBED-CC) PET/CT for detecting tumor location, confirming with conventional imaging, clinical follow-up, and histopathology/biopsy where available.
I. Determine positive predictive value on a per-subject and per-region basis of 68Ga PSMA-HBED-CC PET/CT for detecting tumor location, confirming with histopathology and conventional imaging.
II. Determine sensitivity on per-subject and per-region basis of 68Ga PSMA-HBED-CC PET/CT for detecting tumor location, confirming with histopathology.
III. Determine detection rates on a per-subject basis of 68Ga PSMA-HBED-CC PET/CT stratified by PSA value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 < 2.0, 2.0 - < 5.0, 5.0 or greater.
IV. Continue to evaluate safety of 68Ga PSMA-HBED-CC injection as categorized by Common Terminology Criteria for Adverse Events (CTCAE) 4.03.
I. Determine the impact of 68Ga PSMA-HBED-CC PET/CT on clinical management in patients who have prostate cancer with biochemical recurrence.
Patients receive Ga 68-labeled PSMA-11 intravenously (IV) and then undergo PET/CT scan at baseline. Patients may undergo a second Ga 68-labeled PSMA-11 PET/CT scan if medically indicated.
After completion of study, patients are followed up for 12 months.
Trial Phase & Type
University of Iowa / Holden Comprehensive Cancer Center
Michael M. Graham
Secondary IDs NCI-2019-01061
Clinicaltrials.gov ID NCT03822845